ML18082A687

Draft Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) March 1, 2018 Teleconference Meeting, Pages 1-91

ML18082A687
Person / Time
Issue date:	03/01/2018
From:	Advisory Committee on Reactor Safeguards
To:
Holiday, Sophie
References
NRC-3560
Download: ML18082A687 (91)

Text

Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number:

(n/a)

Location:

teleconference Date:

Thursday, March 1, 2018 Work Order No.:

NRC-3560 Pages 1-91 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 (202) 234-4433

2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION

+ + + + +

ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES

+ + + + +

TELECONFERENCE

+ + + + +

THURSDAY, MARCH 1, 2018

+ + + + +

The meeting was convened via teleconference at 2:00 p.m., Philip O. Alderson, M.D., ACMUI Chairman, presiding.

MEMBERS PRESENT:

PHILIP O. ALDERSON, M.D., Chairman VASKEN DILSIZIAN, M.D., Nuclear Cardiologist DARLENE F. METTER, M.D., Diagnostic Radiologist MICHAEL OHARA, Ph.D., FDA Representative CHRISTOPHER J. PALESTRO, M.D., Nuclear Medicine Physician MICHAEL A. SHEETZ, Radiation Safety Officer JOHN J. SUH, M.D., Radiation Oncologist LAURA M. WEIL, Patients Rights Advocate PAT B. ZANZONICO, Ph.D., Vice Chairman

3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NON-VOTING MEMBERS PRESENT:

RICHARD GREEN MEGAN SHOBER ZOUBIR OUHIB NRC STAFF PRESENT:

CHRISTIAN EINBERG, Acting Deputy Director, NMSS/MSST DOUGLAS BOLLOCK, ACMUI Designated Federal Officer SOPHIE HOLIDAY, ACMUI Alternate Designated Official and ACMUI Coordinator MARYANN AYOADE, NMSS/MSST/MSEB JENNIFER BISHOP, R-III/DNMS SAID DAIBES, Ph.D., NMSS/MSST/MSEB ROBIN ELLIOTT, R-I/DNMS SARA FORSTER, R-III/DNMS LATISCHA HANSON, R-IV/DNMS VINCENT HOLAHAN, Ph.D., NMSS/MSST ESTHER HOUSEMAN, OGC/GCLR/RMR DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB JAN NGUYEN, RI/DNMS PATTY PELKE, R-III/DNMS GRETCHEN RIVERA-CAPELLA, NMSS/MSST/MSEB RAEANN SHANE, NMSS

4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NRC STAFF PRESENT (cont.):

ZAHID SULAIMAN, R-III/DNMS KATHERINE TAPP, Ph.D., NMSS/MSTR/MSEB LESTER TRIPP, R-I/DNMS TARA WEIDNER, R-I/DNMS JENNY WEIL, OCA IRENE WU, NMSS/MSST/MSEB MEMBERS OF THE PUBLIC:

BETTE BLANKENSHIP, American Association of Physicists in Medicine (AAPM)

MARY BURKHART, Illinois Emergency Management Agency (IEMA)

DAVID BURPEE, Bayer Health Care WHITNEY COX, IEMA ROBERT DANSEREAU, New York State Department of Health BRIAN ERASMUS, British Technology Group (BTG)

SHERRIE FLAHERTY, Minnesota Radioactive Materials Unit KAREN FLANIGAN, New Jersey Radioactive Materials Program SANDRA GABRIEL, unaffiliated MUNIR GHESANI, NYU Langone Health BENNETT GREENSPAN, Society of Nuclear Medicine and Molecular Imaging (SNMMI)

5 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MICHAEL GUASTELLA, Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR)

CAITLIN KUBLER, SNMMI RALPH LIETO, St. Joseph Mercy Health System CAROL MARCUS, University of California at Los Angeles (UCLA)

RICHARD MARTIN, American Association of Physicists in Medicine (AAPM)

MICHAEL PETERS, American College of Radiology (ACR)

JOSEPHINE PICCONE, unaffiliated WAYNE POWELL, SNMMI A. ROBERT SCHLEIPMAN, Partners Healthcare EUGENIO SILVERSTRINI, Northwell Health BOBBY SMITH, Mississippi State Department of Health GLENN SULLIVAN, Cardinal Health CINDY TOMLINSON, American Society of Radiation Oncology (ASTRO)

TONY WANG, New York Presbyterian/Columbia University Medical Center JAMES YU, Yale School of Medicine

6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 C-O-N-T-E-N-T-S Call to Order and Welcome..........................7 Opening Remarks....................................7 Report of the Subcommittee........................14 Comments and Questions............................19 Opportunity for Public Comment....................30 Closing Comments..................................77 Public Comments Submitted.........................85

7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1

2:06 p.m.

2 CHAIRMAN ALDERSON: (presiding) Good 3

afternoon, and welcome to today's ACMUI public 4

teleconference.

5 I'm Phil Alderson. I'm the current Chair 6

of the ACMUI.

7 Today we'll be discussing the topic of 8

the Interim Report on Training and Experience 9

Requirements.

10 I'll now turn this meeting to Mr. Bollock 11 from the NRC for opening remarks.

12 MR. BOLLOCK: Thank you, Dr. Alderson.

13 As the Designated Federal Officer for 14 this meeting, I'm pleased to welcome you to this 15 public meeting of the Advisory Committee on the 16 Medical Use of Isotopes.

17 My name is Doug Bollock. I am the Branch 18 Chief of the Medical Safety and Events Assessment 19 Branch, and I've been designated as the Federal 20 Officer for the Advisory Committee, in accordance 21 with 10 CFR Part 7.11.

22 Present today as the Alternate Designated 23 Federal Officer is Sophie Holiday, our ACMUI 24 Coordinator.

25

8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 This is an announced meeting of the 1

Committee. It is being held in accordance with the 2

rules and regulations of the Federal Advisory 3

Committee Act and the Nuclear Regulatory Commission.

4 This meeting is being transcribed by the 5

NRC, and it may also be transcribed and recorded by 6

others.

7 The meeting was announced in the January 8

23rd, 2018 Federal Register, Volume 83, page 3191.

9 The function of the Committee is to 10 advise the staff on issues and questions that arise 11 on the medical use of byproduct materials. The 12 Committee provides counsel to the staff, but does not 13 determine or direct the actual decisions of the staff 14 or the Commission. The NRC solicits the views of the 15 Committee and values their opinions.

16 I request that, whenever possible, we try 17 to reach a consensus on the various issues that we 18 will discuss today, but I also recognize there may be 19 minority or dissenting opinions. If you have such 20 opinions, please allow them to be read into the 21 record.

22 At this point, I would like to perform 23 roll call of the ACMUI membership participating 24 today.

25

9 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Dr. Phil Alderson?

1 CHAIRMAN ALDERSON: Here.

2 MR. BOLLOCK: Dr. Pat Zanzonico?

3 (No response.)

4 Okay. Dr. Vasken Dilsizian?

5 MEMBER DILSIZIAN: Here.

6 MR. BOLLOCK: Dr. Ronald Ennis?

7 (No response.)

8 Okay. Moving on, Dr. Darlene Metter?

9 MEMBER METTER: Here.

10 MR. BOLLOCK: Thank you.

11 Dr. Michael O'Hara?

12 MEMBER O'HARA: Here.

13 MR. BOLLOCK: Thank you.

14 Dr. Christopher Palestro?

15 MEMBER PALESTRO: Here.

16 MR. BOLLOCK: Thank you.

17 Mr. Michael Sheetz?

18 MEMBER SHEETZ: Here.

19 MR. BOLLOCK: Thank you.

20 Dr. John Suh?

21 MEMBER SUH: Here.

22 MR. BOLLOCK: Thank you.

23 And Ms. Laura Weil?

24 MEMBER WEIL: Here.

25

10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MR. BOLLOCK: Thank you.

1 Dr. Zanzonico, did you join us on the 2

conference line?

3 MS. HOLIDAY: I think he might have 4

dialed in with a different passcode.

5 MR. BOLLOCK: Okay. So, we'll try to 6

get Dr. Zanzonico in, but we believe he is able to 7

listen to us at least at this point.

8 OPERATOR: Excuse me. This is the 9

operator. If he is on the line, he can press *0 and 10 I can open his line for him.

11 MS. HOLIDAY: Thank you.

12 MR. BOLLOCK: Okay. Also on the phone, 13 do we have Mr. Zoubir Ouhib?

14 MR. OUHIB: Here.

15 MR. BOLLOCK: Thank you.

16 Mr. Richard Green?

17 MR. GREEN: Here.

18 MR. BOLLOCK: And Ms. Megan Shober?

19 MS. SHOBER: Here.

20 MR. BOLLOCK: Thank you.

21 Mr. Zoubir Ouhib has been selected as the 22 ACMUI Therapy Medical Physicist. Mr. Richard Green 23 has been selected as the ACMUI Nuclear Pharmacist, 24 and Ms. Megan Shober has been selected as the ACMUI 25

11 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Agreement State Representative. Messrs. Ouhib and 1

Green and Ms. Shober are pending security clearance, 2

but may participate in the meeting. However, they 3

do not have voting rights at this time.

4 I now ask NRC staff members who are 5

present to identify themselves. I'll start with the 6

individuals in the room here.

7 DR. HOLAHAN: Vincent Holahan.

8 MS. WU: Irene Wu.

9 DR. DAIBES: Said Daibes.

10 MS. HOLIDAY: Sophie Holiday.

11 MS. HOUSEMAN: Esther Houseman.

12 DR. HOWE: Donna-Beth Howe.

13 MR. EINBERG: Chris Einberg.

14 MS. HOLIDAY: Dr. Katie Tapp is also on 15 the phone.

16 MR. BOLLOCK: All right. Okay. Now 17 I'll go to the NRC Headquarters employees on the 18 phone. Are there any other employees on the phone?

19 MS. HOLIDAY: Maryann Ayoade is also on 20 the phone.

21 MR. BOLLOCK: Okay. Thank you.

22 Members of the public who notified Ms.

23 Holiday that they would be participating in our phone 24 conference will be captured in the transcript. Those 25

12 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of you who did not provide prior notification, please 1

contact Ms.

Holiday at sophie.holiday@nrc.gov.

2 That's S-O-P-H-I-E dot H-O-L-I-D-A-Y @nrc.gov. Or 3

her telephone number is 301-415-7865.

4 We have a bridgeline available, and that 5

phone number is 888-790-6447. The passcode to access 6

the bridgeline is 2790867 followed by the pound key.

7 It is also using the GoToWebinar 8

application to view the presentation handouts real 9

time.

You can access this by going to 10 www.gotowebinar.com and searching for the meeting ID 11 506-651-115.

12 The purpose of this meeting is to discuss 13 the Draft Report for the standing ACMUI Training 14 Experience Subcommittee. Individuals who would like 15 to ask a question or make a comment regarding a 16 specific issue the Committee has discussed should 17 request permission to be recognized by the ACMUI 18 Chairperson, Dr. Philip Alderson. Dr. Alderson, at 19 his option, may entertain comments or questions from 20 members of the public who are participating with us 21 today.

22 Comments and questions are usually 23 addressed by the Committee near the end of the 24 presentation after the Committee has fully discussed 25

13 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the topic. We ask that one person speak at a time, 1

as this meeting is also closed captioned.

2 I would also like to add that the 3

handouts and agenda for this meeting are available at 4

the NRC's public website.

5 At this time, I ask that everyone on the 6

call who is not speaking to place their phones on 7

mute. If you do not have the capability to mute your 8

phone, please press *6 to utilize the conference line 9

mute and unmute functions. I would ask everyone to 10 exercise extreme care to ensure that the background 11 noise is kept at a minimum, as any stray background 12 sounds can be very disruptive on a conference call 13 this large.

14 At this point, I would like to turn the 15 meeting back over to Dr. Alderson.

16 VICE CHAIRMAN ZANZONICO: Doug, this is 17 Pat Zanzonico. Can you confirm that you can now hear 18 me?

19 MR. BOLLOCK: Hi, Dr. Zanzonico. Yes, 20 we can hear you. Thank you.

21 VICE CHAIRMAN ZANZONICO: Thank you.

22 CHAIRMAN ALDERSON: Thank you. Good to 23 have you with us, Dr. Zanzonico.

24 This is Dr. Alderson. And as was said 25

14 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 before, we are discussing today the Interim Report of 1

the Committee's Subcommittee on Training and 2

Experience Requirements. The members of that 3

Subcommittee are Dr. Darlene Metter, Dr. John Suh, 4

Ms. Laura Weil, and Dr. Christopher Palestro, who is 5

the Chair of the Subcommittee.

6 I will now turn the meeting over to Dr.

7 Palestro.

8 MEMBER PALESTRO:

Thank

you, Dr.

9 Alderson.

10 And as Dr. Alderson indicated, this is 11 our Subcommittee's Draft Interim Report. I would 12 like to extend my thanks to Drs. Darlene Metter and 13 John Suh and to Ms. Laura Weil for their invaluable 14 contributions and efforts to put this report 15 together.

16 I

begin with the charge of this 17 Committee. And the specific charge of this 18 Subcommittee is to periodically review the training 19 and experience requirements that are currently in 20 effect for all modalities, which includes both 21 unsealed byproduct materials, 10 CFR 35.100, 200, 22 300, and 1000, as well sealed byproduct materials, 23 35.400,

500, 600, and

1000, and to make 24 recommendations for changes as needed.

25

15 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The guiding principle of our Subcommittee 1

is that we recognize that any recommendations for or 2

against changes in training and experience should 3

ensure that the requirements and provisions in Part 4

35 which, quote, "provide for the radiation safety of 5

workers, the general public, patients, and human 6

research subjects," closed quotes, are satisfied, 7

while simultaneously ensuring that patient access to 8

these procedures is not unnecessarily compromised.

9 And I think it would behoove us to review 10 some of the background, as it gets a bit complicated.

11 In June 2015, as a result of concerns expressed by 12 various stakeholders, a Subcommittee was formed to 13 determine if the 700-hour training requirement placed 14 a hardship on patient access to alpha-and beta-15 emitting therapeutic radiopharmaceuticals and, if 16 necessary, to make recommendations for potential 17 changes and establish recommendations for the total 18 number of hours of training and experience for use of 19 unsealed byproduct material for which a written 20 directive is required. 10 CFR 35.390.

21 Based on its investigation, the 22 Subcommittee concluded that the current requirement 23 of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> for Authorized Users does not adversely 24 affect patient access to these radiopharmaceuticals 25

16 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 and that no change in the training and experience 1

requirements was warranted.

2 The Subcommittee did note, however, that 3

nearly 15 years had passed since the requirements had 4

been updated and recommended that the ACMUI form a 5

subcommittee to periodically review the training and 6

experience requirements for all modalities currently 7

in effect, and to make recommendations for changes as 8

needed. The ACMUI accepted this recommendation, and 9

the Subcommittee on Training and Experience 10 Requirements for All Modalities was formed.

11 The Subcommittee developed a procedure 12 for review of the training and experience 13 requirements, and in order to optimize the review 14 process, planned to begin with 10 CFR 35.100, 15 followed by 35.200, 35.300, et cetera. Due to 16 ongoing concerns about patient access, however, the 17 Subcommittee was directed to prioritize the review of 18 the training and experience requirements for use of 19 unsealed byproduct material for which a written 20 directive is required.

21 Current status. There have been two 22 developments since the ACMUI recommended against 23 changing training and experience requirements under 24 10 CFR 35.390. On January 26th, 2018, the United 25

17 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 States Food and Drug Administrative approved 1

lutetium-177 dotatate for treatment of certain 2

neuroendocrine tumors, given the encouraging results 3

that had been obtained with this agent in clinical 4

trials.

5 In contrast to other therapeutic 6

radiopharmaceuticals which have been approved for 7

very specific situations or indications, such as when 8

other treatments have failed, the indications for 9

lutetium-177 dotatate are much broader and include 10 treatments of somatostatin receptor-positive 11 gastroenteropancreatic neuroendocrine

tumor, or 12 GEP-NETs, N-E-T-S, including foregut, midgut, and 13 hindgut neuroendocrine tumors in adults. And that 14 is from the NDA 208700 approval letter from the FDA.

15 Given the excellent results obtained with 16 lutetium-177 dotatate in clinical trials, the broad 17 indications for its

use, and the fact that 18 neuroendocrine tumors are now the second most common 19 gastrointestinal tumor, it is likely that there will 20 be considerable demand for this agent.

21 In another interim development, the 22 Subcommittee notes with some concern a precipitous 23 decrease in the number of first-time candidates 24 sitting for the certification examination of the 25

18 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 American Board of Nuclear Medicine. In 2016, fewer 1

than 50 individuals sat for this examination, in 2

contrast to 80 to 100 individuals in the past.

3 Furthermore, a

review of 4

the Accreditation Council for Graduate Medical 5

Education database shows a steady decline over the 6

past decade in both the number of nuclear medicine 7

residency programs and the number of residents 8

enrolled in those programs from 57 programs with 161 9

residents in academic year 2007-2008 to 41 programs 10 with 75 residents in academic year 2017-2018. While 11 it is difficult to judge the impact of this decline 12 on patient access, the numerous letters that have 13 been written and the discussions and presentations 14 on this topic that have taken place over the past few 15 years have focused on whether or not there is a 16 sufficient number of Authorized Users. No data had 17 been offered to suggest there is a surplus, nor have 18 future needs been addressed. Thus, the Subcommittee 19 views the decrease in the number of nuclear medicine 20 physicians as a potentially serious problem, perhaps 21 not immediately, but certainly in the future.

22 In view of the potential problems in 23 patient access that could be created by an increase 24 in the number of procedures, combined with a decrease 25

19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 in the number of Authorized Users, the Subcommittee 1

believes that it is time to reconsider the creation 2

of an alternative pathway for Authorized Users for 3

10 CFR 35.390, training for use of unsealed byproduct 4

material for which a written directive is required.

5 While the requirements of an alternative 6

pathway are beyond the scope of this Interim Report, 7

the Subcommittee offers the following items for 8

consideration:

9 The length and scope of the training; 10 The minimum number of administrations 11 that an individual must perform, and whether a total 12 number is sufficient or a specific number per class, 13 alpha and beta; 14 Written certification versus formal 15 examination, and maintenance of competence.

16 The Subcommittee welcomes comments and 17 suggestions.

18 And that concludes the report.

19 MS. HOLIDAY: So, at this time, are there 20 any comments from members on this Subcommittee?

21 MEMBER SUH: This is John Suh.

22 I agree with what has been said in the 23 report.

24 MEMBER METTER: This is Darlene Metter.

25

20 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I agree, too. And I would also like to 1

also mention that in Dr. Palestro's final sentence or 2

near the end, the length and scope of training I think 3

is going to be very important, too, as far as a 4

curriculum development. And, again, assessment of 5

competencies is going to be highly important.

6 MR. GREEN: This is Richard Green.

7 I'm very appreciative of the thorough 8

report and the time taken by the Subcommittee.

9 It's interesting to note that, as stated, 10 nearly 15 years have passed since this was last 11 updated. And being a fan of history, it would be 12 interesting to determine how these values were 13 established. The world certainly has changed. The 14 numbers of radiopharmaceuticals and prices and 15 classes have changed. I think it's certainly time 16 to reevaluate what these values were and what they 17 might be going forward.

18 MEMBER PALESTRO: This is Dr. Palestro.

19 If I can respond to Mr. Green's comment?

20 The answer is we have spent a good deal 21 of time, and NRC staff has put in a lot of time, 22 trying to ascertain how particularly the number of 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> were established. And the answer is it just 24 simply isn't clear from the historical data that are 25

21 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 available. I mean, I think we all agree that the 1

numbers were established with the concept of ensuring 2

the highest quality and safety of care, but why those 3

numbers, in particular, were chosen simply is just 4

not obvious.

5 VICE CHAIRMAN ZANZONICO: This is Pat 6

Zanzonico.

7 I would like to ask a question. If I 8

understood correctly, Dr. Palestro, the Subcommittee 9

concluded that, at least at the moment, there was no 10 shortage of Authorized Users that was currently 11 restricting patient access to these procedures. And 12 that's, obviously, an important criterion, among 13 others, in evaluating whether training requirements, 14 training and experience requirements need to be 15 adjusted.

16 The specific question I have is, as long 17 as the judgment is that there is no shortage of 18 Authorized Users and no restriction in terms of 19 patient access, is there any compelling reason, did 20 the Subcommittee think there would be any compelling 21 reason to offer the training and experience 22 requirements? For example, assuming there is 23 adequate access, patient access, would you still 24 consider either decreasing or increasing the number 25

22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of hours and other training and experience 1

requirements? Or is it necessarily tied to the issue 2

of patient access?

3 MEMBER PALESTRO: Yes, this is Dr.

4 Palestro.

5 In response to your

question, the 6

Subcommittee was formed with the express intention of 7

going through each of the various 35 hundred parts to 8

try to sort that out and determine what, if any, 9

adjustments needed to be made. However, as I 10 indicated in the report, we've been directed to focus 11 specifically on 35.390 because, even though the 12 previous Subcommittee had found no evidence of 13 limiting patient access, these concerns were still 14 expressed by various stakeholders. And now, it is 15 complicated potentially by the fact that we have this 16 new lutetium-177 dotatate coupled with a decrease in 17 the number of nuclear physicians.

18 So, the answer to is there a shortage at 19 the present time, based on what the Subcommittee 20 presented and reviewed, and the ACMUI endorsed two, 21 or maybe it's coming up on three years ago, not at 22 the present time. But we are looking towards the 23 future. I think there is, and I hope I conveyed it 24 in the report, that the potential exists for a 25

23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 shortage in the future. And I personally feel -- and 1

I think the Subcommittee would agree with me -- that 2

it would be better to be proactive rather than 3

reactive, as these things take time to develop.

4 VICE CHAIRMAN ZANZONICO: Understood.

5 Thank you.

6 MEMBER WEIL: If I may add -- this is 7

Laura Weil -- while the Subcommittee's research found 8

no evidence of shortage of Authorized Users, I think 9

it would be a mistake to state that we found that 10 there was demonstrable adequate numbers of Authorized 11 Users in all healthcare settings and in all areas of 12 the United States. We saw no evidence that there is 13 shortage, but we can't say affirmatively that there 14 are enough Authorized Users in all places.

15 MEMBER SHEETZ: This is Mike Sheetz.

16 I'd like to thank the Subcommittee for 17 their work on this topic, and I understand it's a 18 controversial issue.

19 However, I would be cautious in creating 20 an alternative pathway for a use covered under 10 CFR 21 35.390. In my experience, this category includes a 22 multitude of radiopharmaceutical therapies which 23 requires a strong background and understanding in 24 radioprotection, radionuclide handling, and clinical 25

24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 patient care.

1 While some of these therapies may be 2

relatively straightforward with minimal radiation 3

safety issues, others such as the new lutetium-177 4

therapy involves a complex administration procedure, 5

you know, with medical health physics and radiation 6

safety concerns. So, again, therefore, we need to 7

be cautious in reducing the training and experience 8

requirements for this category of radiopharmaceutical 9

therapy.

10 The current training requirements for 11 35.390 require an AU to be Board-certified in nuclear 12 medicine or radiation oncology or, essentially, have 13 completed the equivalent residency program training.

14 I think it's essential for physicians to have this 15 broad background and training provided by these 16 medical specialties to be approved as an AU for 35.390 17 uses. So, I would look to these medical specialty 18 boards to establish what the appropriate training and 19 experience is to practice radiopharmaceutical therapy 20 covered under 35.390.

21 And with respect to the potential patient 22 access issue, I would also look to these medical 23 specialty boards for them to address and make the 24 determination for any changes in current regulatory 25

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 requirements.

1 Thank you.

2 MEMBER PALESTRO: This is Dr. Palestro.

3 Thank you for the comment. In response, 4

I guess because there's been so much discussion about 5

decreasing requirements and shortening

the, 6

quote/unquote, "number of hours," nowhere in the 7

report, nor is it in the Subcommittee's concept, that 8

the thoroughness of training be limited or that an 9

insufficient amount of training and experience and 10 education result.

Whatever 11 suggestions/recommendations made going forward would 12 be made with the concept that any individuals going 13 through the alternative or alternative pathway would 14 have sufficient education, training, and experience.

15 MR. OUHIB: This is Zoubir Ouhib.

16 I will have to echo what was just said, 17 and I think the idea that perhaps, while not proven, 18 that there might be a shortage of Authorized Users, 19 I think lowered the standards will be a huge mistake, 20 in my opinion, which would potentially lead to some 21 outcome that would not be desirable. So, I think the 22 Committee has put a very solid document here to 23 follow.

24 Thank you.

25

26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER DILSIZIAN: Vasken Dilsizian 1

here.

2 I guess I just want to bring in the 3

perspective of a

cardiologist and non-nuclear 4

medicine radiologist who happened to go beyond the 5

cardio training to adequate training to be able to 6

interpret nuclear medicine studies along with nuclear 7

cardiology.

8 So, what I'm saying is that, if there are 9

oncologists, cardiologists, endocrinologists, 10 neurologists who are interested in contributing to 11 the field of science, advancing medical care, 12 providing patient care, after having fulfilled 13 appropriate training as defined by the Committee or 14 by these societies, then this alternative pathway 15 should be available to those physicians. There's no 16 reason why we should not have others who are 17 interested in expanding the field like cardiologists 18 have done. Nuclear cardiology has blossomed since 19 nuclear cardiologists have had access to the imaging, 20 has had a multitude of prognostic outcome data. The 21 field has grown; patients have benefitted. I don't 22 think that we should have a blind approach to not 23 including other medicine subspecialties besides 24 imaging.

25

27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So, I support the concept of defining 1

what it would take to be a competent physician to 2

administer the therapy dose and, then, allow any of 3

the physicians or subspecialties to determine whether 4

they're willing to go through that pathway.

5 MEMBER METTER: This is Darlene Metter.

6 What Vasken just said pretty much is what 7

I believe, in my view, what an alternate pathway is.

8 An alternate pathway is another pathway to achieve 9

the same result. And so, these individuals should 10 have the equal competence as someone who has been 11 certified as a Diplomate of the ABR/ABNM or Radiation 12 Oncology Board certification.

13 I think the problem that we were dealing 14 with was, how do you assess competency in the sense 15 of hours? You have to have a good curriculum for 16 sure, but how do you assess competency? Is it going 17 to be a formal exam or is it going to be just through 18 Board certification? Or what are the pathways do we 19 look at to assess an individual's competency for the 20 radiopharmaceuticals that they'll be administering?

21 MR. GREEN: This is Richard Green.

22 I'd like to echo some of Dr. Palestro's 23 comments.

And just evaluation of the T&E 24 requirements never has been equated with reducing; 25

28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 it's evaluating. But we never had alpha emitters in 1

commercial use, in commercial availability, as we do 2

today. Fifteen years ago when these T&E requirements 3

were evaluated, we never had a mixed beta-gamma 4

emitter like lutetium administered in three courses 5

of therapy at 200 millicuries each.

6 So, we need to evaluate whether what we 7

have today is appropriate and, as Dr. Metter and Dr.

8 Dilsizian have said, make sure that physicians who 9

are supervising these therapies and treating these 10 patients have the right training and experience that 11 is now equated with a decrease. You have to evaluate 12 the adequacy of training and what is really needed to 13 treat patients and meet patients' needs, and they 14 will go wherever that happens to go.

15 CHAIRMAN ALDERSON:

This is Dr.

16 Alderson.

17 Are there further comments from the 18 Committee?

19 MEMBER PALESTRO: Yes, Dr. Alderson, 20 it's Dr. Palestro.

21 I just want to reiterate -- and again, to 22 eliminate any potential confusion -- that the 23 Subcommittee, or that the alternative pathway is not 24 necessarily equated with reducing the number of hours 25

29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 or a shortcut to qualifying for being able to 1

administer these various agents. It's simply just 2

that an alternative pathway could turn out qualified, 3

equally qualified, equally competent individuals.

4 CHAIRMAN ALDERSON: All right. Yes, 5

good. Well said. Well said.

6 Are there further comments from members 7

of the Committee before this goes to the open 8

conference call, to the public?

9 MEMBER SHEETZ: This is Mike Sheetz.

10 I just have one thing to point out. In 11 the current 35.390 requirements, there is an 12 alternative pathway to Board certification, and it 13 includes 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, 200 of which have to be in 14 didactic classroom radiation physics, protection, 15 radiochemistry, radiobiology. So, there exists an 16 alternative pathway to Board certification, but it 17 requires 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. So, I think the issue is, do we 18 come up with a different set of alternatives or 19 criteria than the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />?

20 CHAIRMAN ALDERSON: Are there other 21 comments from the ACMUI?

22 (No response.)

23 Hearing none, I think it's time, then, to 24 go to the operator and see if we have people on the 25

30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 phone who would like to make a comment.

1 OPERATOR: If you would like to ask a 2

question, please press *1 from your phone, unmute 3

your line, and speak your name clearly when prompted.

4 If you would like to withdraw your question, please 5

press *2.

6 One moment while we wait for the first 7

question.

8 (Pause.)

9 Our first question comes from Cindy 10 Tomlinson, ASTRO.

11 Your line is open.

12 MS. TOMLINSON: Thank you.

13 Chairman

Alderson, this is Cindy 14 Tomlinson with ASTRO. Can you hear me okay?

15 CHAIRMAN ALDERSON: Yes, fine.

16 MS. TOMLINSON: Okay. Great.

17 So, I just wanted to thank you for 18 allowing to provide this statement on behalf of ASTRO 19 in response to the Subcommittee's report discussed 20 today. I did submit a written statement. So, I'm 21 just going to summarize what we've stated there.

22 As we stated in October of 2016 to the 23 ACMUI, ASTRO strongly opposes any reduction in the 24 training and experience requirements found in 10 CFR 25

31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 35.390. We believe that these requirements are 1

appropriate, protect the safety of patients, the 2

public, and practitioners, and should not be changed.

3 Radiopharmaceuticals are highly 4

effective in treating cancer, but also potentially 5

hazardous drugs with probable harmful effects to both 6

the patient and the public if not used correctly and 7

under the supervision of a highly trained physician.

8 The rigorous T&E requirements contribute 9

to the excellent safety record of 10 radiopharmaceuticals. We believe that it is 11 important that the person administering the 12 radiopharmaceuticals is appropriately trained in the 13 safe handling, exposure risks, and the management of 14 side effects of radiation.

15 In its report, the Subcommittee expressed 16 its concerns with the decline in the number of nuclear 17 medicine physicians sitting for the certification 18 examination of the American Board of Nuclear 19 Medicine. However, the Subcommittee does not 20 discuss other AUs, including radiation oncologists.

21 The American Board of Radiology estimates 22 that, between 2007 and 20017, approximately 1,650 23 radiation oncologists have been certified by the ABR 24 with an Authorized User eligibility definition and 25

32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 may become Authorized Users. In addition, ASTRO 1

estimates that there are approximately at least 2200 2

radiation oncology facilities in the U.S., which 3

means that, aside from nuclear-medicine-trained AUs 4

nationwide, there are likely enough AUs just among 5

the radiation oncologists.

6 We are not aware of a perceived shortage 7

of radiation oncologists anywhere in the country.

8 However, without being able to identify which AUs are 9

licensed under 35.390 and 35.300, it is not possible 10 to confirm whether there is an actual AU shortage or 11 just a perceived one. Additionally, ASTRO has not 12 heard what would be an ideal number of AUs. Our 13 members are ready to care for patients needing any 14 radiopharmaceutical.

15 In conclusion, for those reasons, we 16 oppose reduction in the T&E requirements for 17 10 CFR 35.390, and we look forward to providing input 18 to the Subcommittee as it continues its 19 deliberations.

20 Thank you.

21 CHAIRMAN ALDERSON: Yes. Thank you for 22 that statement.

23 Would anyone on the ACMUI like to 24 comment?

25

33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER PALESTRO: Yes, Dr. Alderson, 1

it's Dr. Palestro. I have a couple of questions, 2

actually.

3 CHAIRMAN ALDERSON: Please.

4 MS. TOMLINSON: Okay.

5 MEMBER PALESTRO: Okay. Question No. 1, 6

according to your letter, about 1,650 radiation 7

oncologists have been certified with Authorized User 8

eligibility over the past decade, which translates 9

into 165 per year. And I'm just using an average.

10 If we look at nuclear medicine AUs during that same 11 time, based on Board certification, it's roughly 12 about 80 per year. So, all together, over the past 13 10 years, we've been -- or I should say there are 14 about 245 AUs being authorized between these two 15 groups. And I'm not including diagnostic radiology 16 because I really don't know those numbers.

17 However, if, in fact, the trend in 18 nuclear medicine holds, where we've decreased from 19 about 80 down to 40 or 45, that's a 16-percent 20 decrease in incoming or newly authorized AUs, if you 21 will, per year. I don't know how to judge that, but 22 that, to me, is a substantial decrease. If we were 23 to take a very critical view or a very severe view, 24 if all nuclear medicine AUs disappear, and we're 25

34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 talking 85 for those per year or 80 per year, that's 1

a decrease of 35 percent in the total of new AUs, new 2

individuals becoming AUs each year. So, again, 3

those, to my way of thinking, really are numbers to 4

be concerned about.

5 And then, the next question is, you said 6

likely enough AUs just among the radiation 7

oncologists. I would like to know, because this is 8

something that we grappled with a couple of years ago 9

and everyone continues to grapple with, on what basis 10 can you conclude, or do you conclude, that there are, 11 in fact, likely to be enough AUs just based on 12 radiation oncologists alone?

13 MS. TOMLINSON: Right. So, when this 14 issue came up a couple of years ago, we asked the NRC 15 to see if we could get numbers for how many AUs are 16 licensed under 35.390 and under 35.300. And the NRC 17 is unable to do that with any certainty because of 18 the way that they track Authorized Users and with the 19 Agreement States. So, it's really hard for us to -- I 20 mean, I think we're both in agreement that we just 21 don't know, right?

22 MEMBER PALESTRO: Yes. Okay. Yes.

23 MS. TOMLINSON: Yes, we don't know. We 24 don't know what an ideal number is, either.

25

35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER PALESTRO: That's correct.

1 MS. TOMLINSON: So, without knowing 2

that, it's hard to say if a decline is okay or not 3

okay.

4 MEMBER PALESTRO: Okay.

5 MS. TOMLINSON: So, I think it would be 6

helpful if there were some way for the NRC to -- and 7

I don't know, again, if this is something that they 8

can -- I mean, I'm assuming it would take some time, 9

but to figure out exactly who's licensed under which 10 provision in the

regs, because without that 11 information, we're just not going to -- I don't know 12 how you necessarily move forward.

13 MEMBER PALESTRO: The answer is I agree 14 with you; it's really a complicated issue. I mean, 15 if I'm going to misspeak, then, certainly, staff can 16 correct me, but, as I recall, it's almost impossible 17 to determine the number of AUs because, for example, 18 we have a broad license and the AUs are really in-19 house. The state doesn't have numbers for each 20 individual AU. So, it becomes very complicated. I 21 agree with you there.

22 Would you agree with me that there's 23 probably not a surplus they use for these procedures?

24 MS. TOMLINSON: I don't know that I can 25

36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 agree or disagree with you on that.

1 MEMBER PALESTRO: Okay. And then, 2

again, I'm just going to reiterate -- and I will 3

continue to reiterate -- that the alternative pathway 4

does not imply, at least not to me, not to my 5

Subcommittee, or to the ACMUI, that less-well-6 trained, less-well-educated, less-well-experienced 7

individuals will become AUs.

8 MS. TOMLINSON: I don't disagree with 9

that. I think our concern is that, if you relax 10 those requirements and there's not equal competency, 11 as was mentioned earlier, then that would be 12 concerning.

13 MEMBER PALESTRO: Yes, we agree with you.

14 I think the hang-up or the issue that we get into is 15 trying to equate hours with competency.

16 MS. TOMLINSON: Right.

17 MEMBER PALESTRO: And so, I think, 18 potentially, the way around that is to decide what 19 constitutes the knowledge base, if you will, that 20 these individuals should have in order to be granted 21 AU status, and devise a way to determine whether or 22 not they possess that knowledge, whether or not they 23 possess the competency. And I'm not convinced, and 24 I think the educational paradigm of the 21st century 25

37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 is not convinced, that necessarily hours are the way 1

to do, that there are better ways to do it, 2

examinations, and so forth.

3 MS. TOMLINSON: Right.

4 CHAIRMAN ALDERSON: Excellent comments.

5 Further comments from the ACMUI?

6 MR. OUHIB: This is Zoubir.

7 I just have a question regarding the 8

competency. Now, when you move forward and you have 9

additional users or a larger number of users, and you 10 have an Authorized User that's doing a procedure a 11 year -- I'm going to exaggerate here for a 12 second -- how do you define whether that individual 13 is competent by performing one or two procedures a 14 year, year after year?

15 CHAIRMAN ALDERSON:

That's your 16 question?

17 MR. OUHIB: Yes, that is my question.

18 CHAIRMAN ALDERSON: I'll try to step in 19 on that one for a moment. We have to understand, and 20 as part of this call, the scope of the ACMUI's 21 position here. I think, ultimately, we, after much 22 further study and input from the public, might advise 23 the NRC in a particular way, but we would never be 24 the organization responsible for establishing and 25

38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 policing all of these kinds of documentation. As 1

someone earlier said, I mean, it's probably going to 2

roll back to the certifying boards or some other 3

organizations that might be chosen to recommend or to 4

employ such approaches. So, we're a long way from 5

there.

6 And in the same way, since I'm on metrics 7

for a minute, I do understand the discussion 8

revolving around the number of AUs. Out of respect 9

to some of our public input on this issue over the 10 last couple of years, the input has been not simply 11 the metric, but the distribution of the AUs and the 12 concern that in certain areas of the country there 13 was a significant dearth of AUs. So, that particular 14 geographic issue can't be exactly related to the 15 average number of AUs.

16 Would anyone like to comment on Zoubir's 17 proposition?

18 (No response.)

19 Hearing none, then, I think we're ready 20 for the next call.

21 MR. GREEN: Dr. Alderson, this is 22 Richard. May I make a comment quickly?

23 CHAIRMAN ALDERSON: Certainly.

24 MR. GREEN: I appreciate the comments 25

39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 made by the individual from ASTRO, representing 1

ASTRO, and I apologize for forgetting her name. But 2

I have to take a moment to -- there was a statement 3

made that radiopharmaceuticals are highly effective 4

in treating cancer, but are potentially hazardous 5

drugs with possible harmful effects to both the 6

patient and the public if not used correctly.

7 I agree with the statement with the 8

exception of the term "hazardous drugs," which has a 9

definition defined by the -- hazardous drugs is 10 defined by the National Institute of Occupational 11 Safety and Health, or NIOSH, of the Centers for 12 Disease Control and Prevention, the CDC. They 13 publish a NIOSH list of antineoplastic and other 14 hazardous drugs in the healthcare setting that is 15 updated annually. This is now, the standards for 16 handling hazardous drugs is defined by USP Chapter 17 800, which was made official last year. And the 18 definition, according to the Draft Hazardous Drugs 19 Policy and Procedures, NIOSH defines a hazardous drug 20 as "a drug that is approved for human use by the FDA 21 and not otherwise regulated by the U.S. Nuclear 22 Regulatory Commission".

So, by definition, 23 radiopharmaceuticals are not hazardous drugs. I 24 acknowledge that they need to be understood, used 25

40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 appropriately by trained individuals, but I just want 1

to point out that, by definition, they are not 2

hazardous drugs.

3 Thank you.

4 CHAIRMAN ALDERSON: Thank you for that 5

comment, Mr. Green.

6 Further comments?

7 (No response.)

8 So, I think we'll thank ASTRO for its 9

written statement and for its testimony.

10 And we'll go back to the operator and ask 11 if there are further comments that would like to be 12 made by the public.

13 OPERATOR: Dr. Carol Marcus, your line 14 is now open.

15 DR. MARCUS: Thank you very much, and we 16 would like to thank ACMUI for all its diligence in 17 this area.

18 I want to make two points, one of which 19 is the reason for the decreasing number of nuclear 20 medicine residents, and the other point is going to 21 be that I don't believe that the NRC is appropriately 22 enforcing this 700-hour requirement.

23 As to the reason for the decreasing 24 nuclear medicine residents, it's pretty obvious. NRC 25

41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 is chopping up nuclear medicine into bits and pieces 1

and letting other people do it.

Hospital 2

administrators, charged with saving money any way 3

they can in today's reimbursement myth, simply tell 4

those physicians who can be Authorized Users to do so 5

and use that as an excuse to get rid of the well-6 qualified nuclear medicine physicians.

7 So, the reason for nuclear medicine 8

physicians decreasing is simply that they can't get 9

jobs. Obviously, a smart, young physician is not 10 going to go into a field where he can't get a job, 11 because it's being chopped up and given away to 12 everybody else.

13 My second point has to do with the 700 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br />. I'm not going to argue whether 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is 15 the ideal number. I think it's probably a good 16 number. But, having taught for close to 40 years 17 residents in nuclear

medicine, in diagnostic 18 radiology, and in radiation oncology, I would like to 19 certainly challenge whether the diagnostic 20 radiologists are getting 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. And nobody ever 21 checks.

22 The four months' residency that they do 23 during their -- four months' rotation in nuclear 24 medicine that they do during their radiology 25

42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 residency is exactly 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, assuming a 40-hour 1

week. And almost all of that is diagnostic nuclear 2

medicine and not therapy. I would probably doubt 3

that more than 10 or 20 percent of it would be devoted 4

to therapy.

5 And on top of that, they don't really do 6

700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> total over the four months. When you 7

deduct vacation time and time left the next day after 8

doing general radiology night call, the time going to 9

radiology lectures and time covering for other 10 radiology residents who are sick or on maternity 11 leave, one is down to, say, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> in nuclear 12 medicine total. And so, the amount of time spent in 13 therapy is probably 1/10th of the required 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.

14 And there have been many complaints about 15 the quality of nuclear medicine therapy done by 16 diagnostic radiologists by patients, to the point 17 where an organization has been formed of thyroid 18 cancer survivors complaining to the NRC about the 19 quality of therapy that they're getting.

20 And I really think that that 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 21 should be checked, should be inspected, and made sure 22 that the residency programs have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. Because 23 it doesn't make any sense to argue for hours and hours 24 about how many hours you need if the regulator isn't 25

43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 going to check to make sure that those hours of 1

training are being met.

2 Thank you.

3 CHAIRMAN ALDERSON: Would the ACMUI like 4

to comment on that issue? Any comments from the 5

ACMUI?

6 MEMBER METTER: This is Darlene Metter.

7 CHAIRMAN ALDERSON: Dr. Metter, please.

8 MEMBER METTER: So, I've been in academic 9

medicine for over 20 years and been a supervising 10 physician for nuclear medicine Fellows residents and 11 radiology residents. And I understand Dr. Marcus' 12 concern, but the ABR has an exam to assess the 13 competency, if they've learned the information. Now 14 everybody learns in a different way. Someone can 15 learn something in one hour and it takes someone else 16 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />. So, I think the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is an appropriate 17 number, as you said, but I think what I see is that 18 you have certification boards that assess your 19 competency and the assessment of your knowledge and 20 experience and ability to translate that into, 21 quote/unquote, "scenarios in care".

22 CHAIRMAN ALDERSON: Other comments, 23 please, from anyone?

24 (No response.)

25

44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Hearing none, thank you, Dr. Marcus.

1 I think that we're ready for any other 2

members of the public who would like to comment.

3 OPERATOR: We have Jeffry Siegel, and 4

your line is now open.

5 DR. SIEGEL: Hi, Dr. Alderson, members 6

of the ACMUI and NRC. Thank you for the opportunity.

7 All I want to do is make a couple of 8

comments. I don't want to make any recommendations.

9 I want to remind everybody, since you're 10 calling out 35.390 specifically and nothing else 11 right now, that it was predated by -- and you can't 12 be dyslexic for this -- 35.930, where all that was 13 needed was 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. So, during the revision of Part 14 35 in 2004, 390 came into being. And I don't want 15 to argue whether the 700 is correct or not, but if 16 you're not a Board-certified physician and decide to 17 go the alternate pathway, which you're allowed to do, 18 then this is for all four categories. Because if you 19 only want one category, namely, the oral sodium 20 iodide, you could go to 394, which was a carve out 21 for endocrinologists, who only need 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. So, 22 one would, then, have to decide, is there really a 23 difference in safety and protection between somebody 24 administering 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of sodium iodide versus 25

45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 somebody who's administering 100 microcuries of an 1

alpha emitter, as an example? So, there could be, 2

instead of arguing over the alternate pathway in 390, 3

additional carve outs for physicians who specifically 4

want to limit their

practice, just like an 5

endocrinologist does, to a specific category of 6

therapy.

7 And I thank you for allowing me to bring 8

this up.

9 CHAIRMAN ALDERSON: Thank you. Thank 10 you, Dr. Siegel. That is a good point. I'm glad 11 that you made that point. It's not the first time 12 it's been made. In fact, some of the previous input 13 received by the ACMUI from specialty groups has been 14 specifically to that point, that they would like 15 another exception made regarding just the drug that 16 they are interested in.

17 And there has been concern about getting 18 into a situation where, for example, the ACMUI would 19 recommend -- recall that all the ACMUI does is advise 20 and recommend -- that we begin having these carveouts 21 for a whole group of individual drugs one after the 22 other. There's been some concern about that as an 23 approach. But that idea does exist because of the 24 I-131 carveout.

25

46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Would anyone else like to comment on 1

this?

2 (No response.)

3 Anyone on the ACMUI who would like to 4

comment on this issue?

5 (No response.)

6 Well, thank you for the comment, Dr.

7 Siegel.

8 And we'll now go back to the operator and 9

see if there are other members of the public who would 10 like to comment.

11 OPERATOR: I have a Dr. Greenspan.

12 Your line is open.

13 DR. GREENSPAN: Thank you. This is Ben 14 Greenspan. I am the current President of the Society 15 of Nuclear Medicine and Molecular Imaging.

16 We submitted some comments, also, to the 17 ACMUI, and they're fairly similar to those of ASTRO.

18 We do think there should be a decrease in the number 19 of hours.

20 Now I will say that that number, again, 21 is somewhat nebulous. I know it requires 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> 22 of didactic work and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of clinical 23 experience. But I'm not sure that we can really tell 24 competency by number of hours. I think what we need 25

47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to do is make sure people really know what they're 1

doing, that they really are competent. And the best 2

way to do that is provide excellent training and 3

experience.

4 And to be honest, I don't think a 5

certification board is sufficient. In diagnostic 6

radiology, a lot of the residents watch from the back 7

of the room and watch three therapies, and they figure 8

they can go out and treat patients. And I don't 9

think that's sufficient. I think we need to have 10 better oversight of the training, and we need to have 11 an exam to confirm that these people really are 12 competent and know the basics of what they're doing, 13 especially the basic science of radiation biology, 14 radiation safety, and so on.

15 And I am planning to develop a task force 16 to look at the amount of the training and the 17 curriculum that should be required for all sorts of 18 therapies with various radionuclides. I think 19 there's going to be an explosion of these in the 20 future with all sorts of radiopharmaceuticals, with 21 lutetium-177, and a number of other isotopes, maybe 22 actinium-225, and who knows what else?

23 And I think we need to be prepared for 24 that. And so, like I said, I'm going to be starting 25

48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 a task force to look at the curriculum that should be 1

required for all nuclear medicine physicians, and 2

potentially others, if they meet the appropriate 3

training and qualifications, to handle these kinds of 4

therapies in the future, because I think there's 5

going to be an explosion of these.

6 Thank you very much.

7 CHAIRMAN ALDERSON: Thank you, Dr.

8 Greenspan.

9 Comments from the ACMUI about Dr.

10 Greenspan's position?

11 VICE CHAIRMAN ZANZONICO: This is Pat 12 Zanzonico.

13 I'd like to agree. I think, as has been 14 pointed out a number of times, the current training 15 and experience requirements were drafted over a 16 decade ago, and we all recognize and appreciate that 17 there's been major changes in the clinical use of 18 radionuclides with increasing targeted radionuclide 19 therapies and now the use of, and likely increasing 20 use of, alpha emitters. So, while training may or 21 may not have been adequate when originally drafted, 22 it certainly needs to be revisited and critically 23 reevaluated in light of these ongoing advances and 24 refinements in the field.

25

49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN ALDERSON: Thank you, Dr.

1 Zanzonico.

2 Would others like to comment?

3 MEMBER PALESTRO: Yes. This is Dr.

4 Palestro again.

5 I certainly agree with Dr. Greenspan's 6

comments about an examination, and so forth. And 7

again, I'm just going to continue to reemphasize 8

that, as we move forward, the Subcommittee and the 9

ACMUI, and even the NRC, really need to focus on the 10 educational components necessary to turn out 11 qualified individuals, and then, eventually, if 12 necessary, come up with hours. But you can't come 13 up with hours -- it's putting the cart before the 14 horse. We really need to define what is necessary 15 to turn out or to develop competent individuals, and 16 then, if necessary, sort of back the hours into it.

17 CHAIRMAN ALDERSON: Well, whether or not 18 it's hours, I mean, all of us, any of us who have 19 been involved with any of the ABMS boards know that 20 the current thing for the last 15 years has been the 21 development of maintenance of competence and how that 22 is assessed. So, it's probably going to be something 23 more complex even than hours, although hours may be 24 a component of it. So, I think this is a very complex 25

50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 issue and it's not getting any clearer as we move 1

forward. I compliment the NRC and ACMUI on being 2

engaged in this issue at this particular time, but I 3

think we're far from being finished with our 4

deliberations.

5 Are there other comments? Comments from 6

the public or -- I'm sorry -- I should say, first, 7

are there further comments on this particular 8

statement by Dr. Greenspan?

9 MR. OUHIB: This is Zoubir.

10 CHAIRMAN ALDERSON: Yes?

11 MR. OUHIB: Just a quick question. It's 12 regarding the examination component that you had 13 stated. Can you elaborate on that a little bit more?

14 DR. GREENSPAN: Not a lot. First, we 15 intend to develop the educational components 16 necessary, all the basic sciences and clinical 17 requirements, and so on. And then, from that, an 18 exam can be made up that would test the basic 19 requirements.

20 We are willing to draw up an exam. It's 21 not clear who is actually going to be administering 22 an exam like this, but the Society is willing to 23 consider that. But the first step is to develop a 24 curriculum that would handle all these therapies in 25

51 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the

future, and particularly, there may be 1

combinations of alpha and beta emitters being given 2

either simultaneously or consecutively for patients 3

that may benefit them. And so, clinicians need to 4

understand all this.

5 So, I'm sorry I can't give you more of an 6

answer on the examination at this point. We'll have 7

to wait and see how things develop.

8 CHAIRMAN ALDERSON: All right. Thank 9

you. Thank you, Dr. Greenspan.

10 Other comments or questions for Dr.

11 Greenspan?

12 (No response.)

13 Hearing none, to the operator, do we have 14 other public comments?

15 OPERATOR: Next we have Michael Peters.

16 Michael Peters, your line is open.

17 MR. PETERS: Hi. This is Mike Peters 18 with the American College of Radiology.

19 Just a quick comment. So, the latest 20 Subcommittee recommendations pertaining to 390 raise 21 some interesting concepts for contemplation. I might 22 suggest soliciting written comments from the public 23 by publishing a formal Request for Information. You 24 could even include targeted questions for 25

52 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 stakeholders developed by this Subcommittee together 1

with staff. Just some food for thought.

2 CHAIRMAN ALDERSON: Thank you, Mr.

3 Peters.

4 Comments or questions for Mr. Peters?

5 (No response.)

6 Thank you.

7 Hearing

none, Operator, further 8

comments?

9 OPERATOR: We have Michael Guastella.

10 Your line is open.

11 MR. GUASTELLA: Thank you. Good 12 afternoon. This is Michael Guastella from the 13 Council on Radionuclides and Radiopharmaceuticals.

14 And I'd like to take the opportunity this 15 afternoon to reiterate --

16 CHAIRMAN ALDERSON: You'll have to stay 17 closer to your phone, please. Volume up.

18 MR. GUASTELLA: Is that better?

19 CHAIRMAN ALDERSON: Much better.

20 MR. GUASTELLA: Fantastic. Thank you.

21 I just wanted to reiterate some comments 22 that CORAR has offered the ACMUI on this topic in the 23 past. CORAR does support an alternative pathway and 24 an alternative to the current 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. We have 25

53 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 recommended a specific scope of training requirements 1

for radioisotope handling and radiation safety for 2

physicians that are wishing to administer intravenous 3

therapeutic radiopharmaceuticals containing alpha-4 and beta-emitting radioisotopes, which -- and this is 5

important -- which have been prepared by a licensed 6

nuclear pharmacist in a state-licensed radiopharmacy 7

and dispensed to physicians as patient-ready doses.

8 In determining the appropriate amount of 9

time and scope of content for radioisotope handling 10 and radiation safety training the physicians must 11 have, and physicians such as medical oncologists and 12 hematologists -- we haven't heard too much about 13 these specialties today in the call -- they should 14 receive the amount of training that will enable them 15 to safely administer these types of therapeutic 16 drugs.

17 And we've offered some of the following 18 factors to the ACMUI to consider, such as: the 19 limited role in handling these radiolabeled 20 therapeutic drugs, which, again, would be dispensed 21 and delivered to them in patient-ready doses from a 22 licensed radiopharmacy; the radiological safety 23 profiles of radiopharmaceuticals containing alpha-24 and beta-emitting isotopes, and, finally, physicians 25

54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 experienced and trained handling toxic non-1 radioactive chemical therapies, such as cytotoxic 2

chemotherapy agents.

3 Thank you.

4 CHAIRMAN ALDERSON: You're welcome.

5 Comments? Any comments regarding what 6

was just said?

7 MR. GREEN: Dr. Alderson, this is Richard 8

Green.

9 CHAIRMAN ALDERSON:

Yes, Richard, 10 please.

11 MR. GREEN: Mr. Guastella was bringing 12 up concepts that I know that some of the NRC 13 Commissioners have asked the NRC to evaluate, NRC 14 staff to evaluate. Does the concept of mode of 15 receipt have a role to play in the training and 16 experience requirements? These beta-, gamma-, and 17 alpha-emitting therapeutics -- and I agree with Dr.

18 Greenspan, I think that's where the growth in the 19 industry is going to be in these therapeutics -- do 20 not require formulation, a kit, compounding, do not 21 require imaging with a gamma camera or quality 22 control of a gamma camera.

23 So, I think it's important that we 24 evaluate not just the compounds and the 35.390, but 25

55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 what is the manner of receipt? Because I think that 1

may also play into the T&E requirements.

2 Thank you.

3 CHAIRMAN ALDERSON: Thank you. Yes.

4 that is exactly what he was driving at.

5 Further comments on that issue?

6 (No response.)

7 Thank you.

8

Operator, are there further public 9

comments?

10 OPERATOR: Dr. Carol Marcus, your line 11 is open.

12 DR. MARCUS: Thank you very much.

13 I just wanted to make a comment about 14 some of the other outside commenters.

15 CHAIRMAN ALDERSON: Please.

16 DR. MARCUS: I was on the ACMUI from 1990 17 to 1994. And near the end of my term, when NRC was 18 contemplating redoing all the medical regulations, 19 which it did in 1997, the ACMUI made two unanimous 20 recommendations. One was to get rid of that two-week 21 80-hour endocrinology course for using I-131, which 22 is a throwback to the old days of the AEC right after 23 the Second World War. Because they did not feel that 24 two weeks of training was enough to learn the basic 25

56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 radiation and nuclear sciences that you really needed 1

to know to handle I-131.

2 And the other recommendation that they 3

made unanimously was to have an exam in basic nuclear 4

and radiation sciences for anybody who wanted to 5

practice any kind of nuclear medicine. And this 6

requirement was actually in the first draft of the 7

regulations, but at the very end this appeared. NRC 8

reasoned that it would be too difficult to make a 9

different basic radiation and nuclear science exam 10 for each group of licensees. That was their excuse, 11 but we had in mind only one exam for any licensee.

12 And what we basically thought was that the NRC was 13 afraid that the people it was selling licenses to 14 wouldn't be able to pass the exam and they would lose 15 a lot of user fee money, and they need that user fee 16 money to support their staff.

17 This is always something that should be 18 kept in mind that NRC has to raise user fees to 19 support its regulatory program. And anything that 20 decreases the number of users is a threat to its 21 staff.

22 But the idea of the exam that Dr.

23 Greenspan talked about was a unanimous recommendation 24 of the ACMUI around 1994.

25

57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Thank you.

1 CHAIRMAN ALDERSON: Thank you, Dr.

2 Marcus.

3 Would anyone like to comment on this 4

comment by Dr. Marcus?

5 (No response.)

6 Well, I think the fact that these issues 7

existed 20 years ago, and they still exist in 8

different context today, speaks to their complexity.

9 Would anyone like to make a comment?

10 VICE CHAIRMAN ZANZONICO: This is Pat 11 Zanzonico.

12 The notion that Dr. Marcus just raised of 13 a single competency exam or competency metric, even 14 if it weren't an exam, for all users I think is a 15 compelling one because the implication would be, if 16 prospective AUs did not take the same exam, what is 17 it that they did not need to know that was covered in 18 the exam, the compartmentalized exam they did take 19 versus another subspecialist may take? I think 20 that's a challenging question to answer. I mean, I 21 think there is a knowledge base and a competency base 22 that all physicians who work with radioactive 23 materials, regardless of the specific application 24 they are involved in, need to know. And if one starts 25

58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 parsing the metrics of competency, whether by 1

different exams, and so forth, it does beg the 2

question, what is it that one physician who uses 3

radioactive material does not need to know to use 4

those materials safely and effectively?

5 CHAIRMAN ALDERSON: Thank you, Dr.

6 Zanzonico.

7 Would others like to comment?

8 MR. OUHIB: Yes. This is Zoubir.

9 I'm not really sure whether my statement 10 will be fair. But, if you have an individual, an 11 Authorized User, who specializes in one particular 12 element, wouldn't that provide less choices to 13 patient care in comparison to somebody who is 14 qualified and competent in providing all the others, 15 for that matter? It is just a thought.

16 CHAIRMAN ALDERSON: Right. It's a 17 difficult part of the problem.

18 Other comments?

19 VICE CHAIRMAN ZANZONICO: Well, just a 20 follow-up to that last comment. This is Pat 21 Zanzonico again.

22 CHAIRMAN ALDERSON: Yes, sure, Pat.

23 VICE CHAIRMAN ZANZONICO: Certainly I 24 agree there may be differences in details of what 25

59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 particular physicians specializing in certain 1

applications may need to know, and that's an arguable 2

point certainly. But my initial feeling is that 3

there's much more in common that clinical users of 4

radioactive materials need to know, regardless of 5

their specific application, than there is different 6

among those applications. But, again, I concede it's 7

an arguable point, or at least that's my initial 8

feeling.

9 CHAIRMAN ALDERSON: Thank you.

10 Further comments?

11 (No response.)

12 Hearing none, back to the operator for 13 the next public comment.

14 OPERATOR: We have Jeffry Siegel.

15 Your line is open.

16 DR. SIEGEL: Hi. Sorry. I'm sure 17 you're all aware of this, but I want to make sure you 18 are, so we're not at 390 again five years from now.

19 You all know that the categories of use are only two 20 oral and two parenteral. So, my question is, since 21 so many new agents are coming down the pike, what 22 happens if this new agent is not oral or parentally 23 administered?

24 Thanks very much.

25

60 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN ALDERSON:

Oh, excellent 1

question. Would someone on the ACMUI or the NRC like 2

or the FDA like to answer that question?

3 MEMBER PALESTRO: Dr. Alderson, it's not 4

Dr. Palestro.

5 CHAIRMAN ALDERSON: Yes?

6 MEMBER PALESTRO: The Subcommittee that 7

is charged with reviewing the training and experience 8

requirements was established specifically to conduct 9

ongoing reviews in order to minimize the likelihood 10 of falling out of step with the times. So that, as 11 new agents become available, the Subcommittee would 12 review them, or potentially available, if we know 13 they're in the pipeline, review them and develop 14 recommendations about what, if any, additional 15 training would be required or perhaps a modification 16 in the current rules.

17 DR. SIEGEL: Right. Is my line still 18 open?

19 CHAIRMAN ALDERSON: Is this Dr. Siegel?

20 DR. SIEGEL: Yes.

21 CHAIRMAN ALDERSON: Yes, we can still 22 hear you.

23 DR. SIEGEL: Oh, okay, great. Yes.

24 No, I realize that. I'm just saying that 25

61 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 there's no carve out or there's no way in 390 that 1

one could even consider a different route of 2

administration. You have to go through 1,000 and 3

argue again what training and experience was 4

necessary for this new form of administration. So, 5

all I'm saying is maybe you want to not categorize 6

these four categories the way you have. And this is 7

an NRC question, I suspect.

8 MS. HOLIDAY: Dr. Alderson, this is 9

Sophie, if I may?

10 CHAIRMAN ALDERSON: Please.

11 MS. HOLIDAY: So, Dr. Siegel is asking 12 what happens if a radiopharmaceutical is neither oral 13 or parenteral,

but, in actuality, parenteral 14 administration simply means that it's anything other 15 than oral administration.

16 CHAIRMAN ALDERSON: That's the way that 17 the NRC has defined that?

18 MS. HOLIDAY: Correct.

19 CHAIRMAN ALDERSON: Okay.

20 MS. HOLIDAY: And I actually looked up 21 the definition, and the definition for "parenteral" 22 is "administered or occurring elsewhere in the body, 23 then the mouth and alimentary canal".

24 CHAIRMAN ALDERSON: And we have a 25

62 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 representative from the FDA with us. Is that 1

consistent with what the FDA thinks?

2 MEMBER O'HARA: Yes, it is. I also can't 3

say anything about any new form of delivery that may 4

be being looked at by the FDA. It would be classified 5

as something that is being reviewed by the FDA right 6

now. So, I can't say anything, if there is something 7

like that coming down the pike.

8 CHAIRMAN ALDERSON: So, given what Ms.

9 Holiday has just said, and the agreement, or at least 10 general agreement, from the FDA, I'll just make an 11 example here to try to increase my own clarity on the 12 issue. So, we all understand the oral part. It's 13 the parenteral -- and that's how, generally, I was 14 taught to say that

word, "parenteral --

so, 15 parenteral could be some sort of an intramuscular 16 injection.

What about inhalation?

Would 17 inhalation, if there was a drug that could be inhaled 18 and would go in through the lungs, would that be 19 considered parenteral?

20 MR. GREEN: Dr. Alderson?

21 CHAIRMAN ALDERSON: Yes?

22 MR. GREEN: As a pharmacist, I would have 23 to defer to, you know, that's a different route. And 24 I would also say that transdermal would be a different 25

63 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 route. It's not through the oral, you know, 1

alimentary canal down the mouth.

2 CHAIRMAN ALDERSON: Correct.

3 MR. GREEN: And it's not injected through 4

a layer of skin. But I would say that inhalation or 5

transdermal are other routes that are not encompassed 6

in today's regulatory status.

7 CHAIRMAN ALDERSON: So, you would not 8

believe, Mr. Green, that those would be considered 9

parenteral?

10 MR. GREEN: I would not classify them 11 that way.

12 CHAIRMAN ALDERSON: Oh. So, we aren't 13 going to resolve this discussion, but it just seems 14 that we have, between the regulators and people who 15 are really looking at these issues from other points 16 of view, that even this definition would come under 17 scrutiny. So, another example of the complexity of 18 the issue.

19 And so, Dr. Siegel, thank you for 20 bringing that issue up to us.

21 Further comments on this route-of-22 administration issue?

23 MEMBER PALESTRO: Dr. Alderson, it's Dr.

24 Palestro.

25

64 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN ALDERSON: Yes?

1 MEMBER PALESTRO: Given the questions 2

that have arisen, as the Subcommittee and the ACMUI 3

and the NRC continue to move forward on the issues, 4

I think it would be extremely important for us to 5

receive clarification of any specific definition of 6

what "parenteral" means to the regulators, not 7

necessarily what is stated in Webster's dictionary, 8

but the definition according to the regulators.

9 CHAIRMAN ALDERSON: Yes, very good.

10 Very good. I think that's quite correct, and 11 hopefully, some of our people from the NRC and the 12 FDA can work with their groups on that particular 13 issue and let us know how they -- well, I think we 14 know how Sophie and the NRC feels. So, I guess we 15 have to know of the FDA. We thought it seemed to 16 agree, but Mr. Green said some other groups would 17 not. So, we have to find out what's really out there 18 and include that in future discussions.

19 MEMBER O'HARA: Dr. Alderson, I'll talk 20 to the people on the drug side for the actual 21 definition.

22 CHAIRMAN ALDERSON: Okay. That's good.

23 That's good, too. And we'll try to see if we can get 24 everyone to agree.

25

65 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 All right. Thank you.

1 Any further comments on this route-of-2 administration issue?

3 (No response.)

4 Hearing none, is there another comment 5

from the public?

6 OPERATOR: There is no one else on the 7

phone queue.

8 CHAIRMAN ALDERSON:

All right.

9 Operator, why don't you please ask for further 10 comments from the public? And we'll give people a 11 chance who haven't thus far gotten online.

12 OPERATOR: Again, if you would like to 13 ask a question, please press *1 from your phone, 14 unmute your line, and speak your name clearly when 15 prompted. If you would like to withdraw your 16 question, you can press *2.

17 One moment while we wait for any further 18 questions.

19 (Pause.)

20 One moment. I do have someone that 21 queued in. Just one moment, please.

22 (Pause.)

23 We have a question from David.

24 Your line is now open.

25

66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MR. BURPEE: Thank you.

1 David Burpee with Bayer Pharmaceuticals.

2 I work for licensing customers to ultimately be able 3

to legally ship product to them.

4 So, I want to thank the Committee and 5

everyone involved. This is very, very important work 6

because on the street level that I work with for 7

finding Authorized Users and helping them to 8

appropriately be a part of it, there's many 9

difficulties. And several have been touched on in 10 your discussion.

11 There is a

geographic distribution 12 problem. So, yes, there's plenty of Authorized Users 13 that can work with this, with these products in 14 Chicago, but in the Upper Peninsula of Michigan I 15 have several accounts that have been struggling to 16 have an Authorized User for over a year. And so, 17 that means these patients have to travel many hours 18 managing a great deal of pain. And so, this is a big 19 problem. And so, thank you again for this work.

20 It's vital.

21 The complexity that I'm hearing is what 22 I see every day, too, and the differences in what is 23 required to be an Authorized User. Jeff Siegel 24 brought up the 394. There's also 396, which is 25

67 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 specifically for brachytherapy and eBr2 REDOX 1

requiring 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, including 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. And so, 2

it's a question about why the discrepancy of that 3

versus the 200 and the 390. But I do believe it 4

relates to the complexities of these isotopes that 5

are coming down the road.

6 So, a

suggestion may be, for 7

determination perhaps of each isotope as to its 8

safety and how complex it is for handling and working 9

with, that there maybe be a baseline, like 396, and 10 then, as the complexity goes up -- so, for example, 11 comparing alpha at 100 microcuries of a typical dose 12 to the lutetium products around 200 millicuries, that 13 there would be different standards perhaps, maybe 14 under 1,000, that would work for the right training 15 and the competency. I like the comment one person 16 had about how do we determine competency for each of 17 these isotopes.

18 So, I hope those thoughts help, and 19 again, thank you for your important work.

20 CHAIRMAN ALDERSON: Thank you.

21 Comments from the ACMUI on this last 22 phone call?

23 MEMBER WEIL: This is Laura Weil. I 24 would like to comment.

25

68 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN ALDERSON: Yes, Laura.

1 MEMBER WEIL: To the comment regarding 2

the raw number of Authorized Users, it does not 3

necessarily ensure patient access. The geographic 4

distribution of those Authorized Users has to be 5

taken into account.

6 Thank you.

7 CHAIRMAN ALDERSON: Yes. Good. Thank 8

you, Laura.

9 Further comments from the ACMUI?

10 MEMBER PALESTRO: Yes, Dr. Alderson, 11 this is Dr. Palestro.

12 Laura makes a very valid point. The 13 problem is you can't legislate geographic 14 distribution. And I don't know how that's overcome.

15 I think that's a completely separate issue.

16 CHAIRMAN ALDERSON: Thank you, Dr.

17 Palestro.

18 Further comments?

19 VICE CHAIRMAN ZANZONICO: This is Pat 20 Zanzonico.

21 I think we all certainly understand and 22 empathize with patients who really are put out to 23 undergo a specific procedure, a specific procedure of 24 any kind. And there are all kinds of medical 25

69 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 procedures from open heart surgery to whatever that 1

are only done in specialized centers, likewise, some 2

forms of cancer chemotherapy. And as unfair and as 3

onerous as it may be, those procedures are performed 4

only at centers where the practitioners are competent 5

to perform them.

6 And while accessibility should be a 7

consideration in using radiopharmaceuticals 8

clinically, certainly in therapy, in particular, it 9

just strikes me it can't be a decisive consideration, 10 just as it can't be a decisive consideration in who 11 can perform all sorts of very complex medical 12 procedures that often are available only at tertiary 13 care academic medical centers.

14 CHAIRMAN ALDERSON: Thank you, Dr.

15 Zanzonico, for reminding us of that reality.

16 Further comments?

17 MEMBER WEIL: This is Laura Weil again.

18 Just one further clarification.

19 I'm not suggesting that accessibility is 20 in any way a substitute for competence. But I think 21 when we try to make the argument that there's no need 22 to look for an alternate pathway because there are 23 plenty of Authorized Users already available, we have 24 to be careful how we use the word "available" because, 25

70 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 then, it's a fallacy to say that every patient in the 1

United States has access to an Authorized User, where 2

there might be another way, if there's an alternate 3

pathway, there might be a way to have people in the 4

community who are perfectly competent and well-5 trained and able to offer those services to people in 6

different geographic locations.

7 CHAIRMAN ALDERSON: Thank you, Ms. Weil.

8 Further ACMUI comments?

9 (No response.)

10 Hearing none, we'll go back to the 11 operator and see if there are any more public 12 comments.

13 OPERATOR: I have Munir Ghesani.

14 Your line is open.

15 DR. GHESANI: Thank you. Thank you to 16 the Committee for giving the opportunity to speak.

17 And thank you, ACMUI Committee, for putting this 18 extensive work and coming up with the recommendations 19 and report.

20 For disclosure, I'm the Human Relations 21 Chair for SNMMI and I'm also a member of the American 22 Board of Nuclear Medicine. But these opinions -- and 23 we have formal comments submitted by SNMMI, and Ben 24 Greenspan already mentioned earlier. But I would 25

71 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 like to add a few more, actually, two big comments.

1 One of them is about the discussion that 2

we had about the geographic distribution and 3

availability of Authorized Users based on geographic 4

location. While that may be true in certain parts 5

of the country, you have to also, as was mentioned by 6

Pat Zanzonico, that he is going to look into the fact 7

that that's the nature of the healthcare setup. And 8

for the patients who are actually coming for this 9

kind of treatment, they may also need a more extensive 10 consult in post-treatment follow-up as well as 11 handling of any complications.

12 So, in many ways, it is given, when 13 you're looking at a very tertiary mode of treatment, 14 that the patients are actually expected, and often 15 willing, to look for the nearest alternative, which 16 may not be next door in many instances. And 17 practicing in New York, I see that many patients that 18 we see in our daily practice do actually come from 19 surrounding areas and travel quite extensively to 20 come to a major tertiary center for their care. So, 21 I think we should be careful in not looking at the 22 geographic availability of the Authorized Users in 23 isolation.

24 The second point I wanted to make was 25

72 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that, based on the earlier discussions, I saw that 1

there's quite a bit of uncertainty about the extent 2

of Authorized Users and perceived shortage in the 3

future. And I think we have plenty on it. Now 4

anytime we think about preemptive, it's always a good 5

idea because that avoids any catastrophe or crisis 6

that may come up in the future. But, on the other 7

hand, acting preemptively on data that's not 8

sufficient, I don't see that could be justified, 9

especially since there were comments made from the 10 radiation oncology community about their availability 11 of Authorized Users that has not decreased in number.

12 As far as the ABNM is concerned, in fact, 13 I highly recommend that you look at the most recent 14 data where not only the drop that occurred has now 15 plateaued out, but, in fact, there's actually a 16 slight, but certain, trend towards increased number 17 of diplomates. Now it's not dramatic increase to the 18 point that it meets the level that was seen in early 19 2000, but, nonetheless, it is an encouraging sign, 20 not to mention that there is actually a second pool 21 of residents who many of them -- as you know, the 22 American Board of Radiology has created this 23 alternate pathway, which ABNM has also supported, and 24 that's available. So that there is an increasing 25

73 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 number of residents actually looking at that path.

1 In fact, I was one of the first ones in the country 2

who started this pathway, and within my very first 3

year of offering it for residents, has stepped up.

4 And so, just to be careful about the 5

number of Authorized Users, about perceived shortage.

6 We do have another pool of residents from radiology 7

who are training for 12 months of their 16. You 8

know, they're training 16 months out of their four 9

years of radiology residency, and many of them are 10 offered an additional fellowship in nuclear FCT that 11 allows them to become more competent in delivering 12 these kinds of treatments.

13 And when you are talking about these 14 treatments, they are not given in isolation.

15 Oftentimes, there's a close correlation of imaging 16 study that needs to be done. And you have to be 17 very, very careful when you carve out a small section 18 that only those trained properly administer these 19 treatment. But the treatment is not given in 20 isolation. There's a good part of training, whether 21 it's in the nuclear medicine or in radiology that 22 actually involves not just the radiation safety, but 23 overall concepts of radiopharmacy physics as well as 24 overall concepts of imaging, and combining the 25

74 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 imaging correlation with the treatment.

1 So, needless to say that it's very, very 2

premature, and I think it's not advisable, to look at 3

this treatment as something that happens in isolation 4

in the care of the patient. It has to be taken into 5

account a full spectrum of what goes on before you 6

decide to give a treatment, and many of those who are 7

in the audience right now know who are treating these 8

patients that imaging plays a crucial role before you 9

even think about administering the treatment, not to 10 mention that after administering that treatment, you 11 have to continuously follow these patients to make 12 sure in which direction your treatment is going.

13 So, I highly advise that this whole 14 concept of creating a new channel for treatment alone 15 is not a good and advisable concept.

16 CHAIRMAN ALDERSON: Thank you. Thank 17 you, Dr. Ghesani.

18 Comments on that?

19 MEMBER PALESTRO: Yes. This is Dr.

20 Palestro. I have a couple of comments.

21 No. 1, getting back to the geographic 22 distribution, the role of the Subcommittee and the 23 ACMUI is to ensure that the rules and regulations and 24 training and experience are sufficient that the 25

75 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 individuals who will be using these various 1

radiopharmaceuticals are competent.

We can't 2

control which ones they choose to use, nor is it 3

within our purview to do that. Similarly, it's not 4

within our purview to control shortages that may be 5

related to geographic distribution. We're simply 6

there to ensure competence in these individuals and 7

to ensure that our rules and regulations are not 8

limiting access or keeping the numbers of individuals 9

trained artificially down.

10 In terms of the numbers for nuclear 11 medicine, you know what? I was on the American Board 12 of Nuclear Medicine for seven years. I was Chair.

13 I was on the ACGME Residency Review Committee for 14 seven years. I was Chair. And there have been 15 numerous various attempts at slowing the decreasing 16 trend or the trend in decreasing numbers of residents 17 and taking the board, and so forth, over that time.

18 And the long and the short of it is, they have not 19 met with very much success.

20 The new concept may or may not turn 21 things around. I don't know. But I think, rather 22 than sitting back and waiting to see what happens or 23 anticipating that things are going to get better, 24 when we've got 10 years of history that say they 25

76 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 haven't gotten better, is a mistake. And I think 1

that we do need to be proactive and begin evaluating 2

the future and see where we stand, to avoid any 3

potential calamities.

4 And as far as having an adequate number 5

of AUs at the present time, again, there's no basis 6

in fact for any of that. It's a hypothesis. It may 7

be an educated guess. But none of us can sit down 8

and say that, yes, there are sufficient number of AUs 9

with any degree of certainty.

10 And what, in fact, the Subcommittee said 11 a couple of years ago was that there was nothing to 12 suggest that the explanation for the decreasing use 13 of one particular agent was related to a shortage or 14 a lack of AUs. So, it's a little bit different.

15 DR. GHESANI: Is my line still open?

16 CHAIRMAN ALDERSON: Whoever you are -- we 17 don't know who you are, but your line is open. We 18 can hear you.

19 DR. GHESANI: Yes, this is Munir Ghesani.

20 Thank you, Dr. Palestro, for the detailed 21 explanation, and I fully respect your judgment and 22 your observation about the ABNM noticing the drop.

23 But I still am currently a member of the 24 Board, and I just finished my tenure as the Chairman 25

77 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of the Board. And we have acknowledged that the drop 1

has been there, but the most recent data is suggesting 2

that it has plateaued out. And as I indicated, the 3

most recent one for this year has been a slight 4

internal increase in the number of applicants.

5 And the other noticeable change that we 6

have observed, and it is very much out in the public, 7

is that amongst the increase, as well as overall, 8

there are an increasing number of candidates who are 9

dual-certified. So, the offer of the 16-month 10 pathway occurred in 2010. Of course, when you offer 11 a new track in a long residency program, it takes 12 four or five years to notice the difference. And so, 13 this would be the first few years that are showing a 14 little bit of change. And I think that if the trend 15 continues and if the dual pathway is offered at the 16 same rate

and, hopefully, at the increasing 17 institutions, then you will clearly have the benefit 18 of having more potential Authorized Users going into 19 practice in the future.

20 With regards to your observation about 21 the insufficient number of Authorized Users, you 22 mentioned that the ACMUI -- in fact, I was on that 23 call, and it was very clear that at that time it was 24 noticed by the ACMUI Subcommittee that there was no 25

78 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 such issue with regards to geographic availability 1

and overall shortage of the Authorized Users.

2 So, if that's the case, and if we don't 3

have a handle on the total number of Authorized Users 4

now or going into the future, I still maintain my 5

position that it is a little bit premature to be 6

preemptive without having a complete knowledge of 7

data for analytics. In the business world, people 8

would always rely on the data before making any future 9

decisions. And I think the practice of medicine 10 should be no different in that regard.

11 CHAIRMAN ALDERSON: Thank you, Dr.

12 Ghesani.

13 Further comments?

14 MEMBER PALESTRO: Yes. This is Dr.

15 Palestro. I would just like to respond briefly to 16 Dr. Ghesani.

17 No. 1, in terms of preemptive, I don't 18 think it's preemptive. I think it's more being 19 proactive. It's not something that's going to occur 20 overnight. As Dr. Alderson indicated, this is a slow 21 process that takes a lot of work.

22 Getting back to your comment on business, 23 they won't act until they have the data, again, I 24 have 10 years of data for the ABNM that shows a 25

79 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 decreasing trend. And if I'm going to follow your 1

suggestion on the way business would act, I would be 2

acting on those 10 years of data before I would be 3

sitting back and waiting for something hopefully to 4

happen.

5 That's not to suggest that it's not going 6

to happen. I hope it does. My whole career is built 7

on nuclear medicine. There's nothing enjoyable about 8

watching the number of individuals training in 9

nuclear medicine decrease. But I do have 10 years 10 of data that suggests that the numbers -- in fact, it 11 doesn't suggest -- it confirms the numbers have 12 continually decreased. And those are the data that 13 I have in front of me. And I don't think -- I 14 personally don't want to wait four or five years to 15 see whether or not the trend has actually changed.

16 CHAIRMAN ALDERSON: Thank you, Mr.

17 Palestro.

18 DR. GHESANI: Yes, Dr. Palestro, your 19 point is very well-taken, and no doubt that this is 20 an observation. But, while we are making a decision, 21 it would be prudent to also see the most recent trends 22 that have occurred.

23 And I fully agree that the process takes 24 time. And if that's the case, then it may be even 25

80 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 more advisable to look at the most recent data and 1

revisit the idea about where the trend is going.

2 Because there's no question that the last 10 years 3

have shown the trend to be in that direction, but, 4

you know, the last couple of years have been somewhat 5

different. And that should be strongly taken into 6

account before putting it all together.

7 CHAIRMAN ALDERSON: Thank you. So, yes, 8

the number of diplomates in one particular board are 9

a component of the AU availability issue, but I would 10 hope that we can stay off the details of the work of 11 one particular board at this particular time. I 12 think we've heard good comments on that, and thanks 13 to all of you.

14 Are there other people online at this 15 time who would like to make a new comment?

16 OPERATOR: We have no one else in the 17 queue.

18 CHAIRMAN ALDERSON: No one is in the 19 queue.

20 Are there other comments from members of 21 the ACMUI?

22 MR. OUHIB: This is Zoubir.

23 Just a brief comment regarding item 1 24 that was brought up. I think it's a very important 25

81 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 one, as the healthcare business is looking into 1

Centers of Excellence. And I really believe that 2

these procedures are not just a matter of injecting 3

a dose, or whatever. There's a comprehensive care 4

that actually takes place, and I think that we need 5

to keep that in mind. I fully understand that is not 6

the scope of this Committee. However, that needs to 7

be kept in mind.

8 CHAIRMAN ALDERSON: Thank you.

9 Further comments from the ACMUI?

10 (No response.)

11 Hearing none, and hearing that there are 12 no people online, I believe that we can turn this 13 back to Mr. Bollock and the NRC.

14 MR. BOLLOCK: Thank you, Dr. Alderson.

15 And I appreciate the time, and I 16 appreciate all the comments and the Subcommittee's 17 report, the discussion, and the public comments on 18 all these. It is a very complex topic, a lot of 19 different considerations in this area.

20 I just want to remind the Committee that 21 the staff has been tasked by the Commission to 22 evaluate whether it makes sense to establish tailored 23 training/experience requirements for different 24 categories of radiopharmaceuticals; how those 25

82 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 categories should be determined, such as by risks 1

posed by groups of radionuclides or by delivery 2

method; what the appropriate senior requirements 3

would be for each category, and whether those 4

requirements should be based on hours of 5

training/experience or focused more on competency.

6 So, we owe that to the Commission at the end of the 7

summer.

8 We will be providing our Draft Evaluation 9

to the ACMUI probably in about two months, give or 10 take, when we've drafted it.

11 Again, this is the staff's, this is just 12 the staff evaluation. It is not the Commission's.

13 It's a draft. And we listened to all the comments 14 we've heard. I think there was a comment that 15 touched on almost every one of these categories I 16 just said. So, we do appreciate all of that and the 17 insights we've received, both by the ACMUI and the 18 public.

19 CHAIRMAN ALDERSON: Excellent. Thank 20 you.

21 Are there any other further issues to be 22 brought before the group today?

23 (No response.)

24 I don't believe there's anything for us 25

83 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to approve. I think this has been a broad-ranging 1

discussion, and there are, as Mr. Bollock indicated 2

just now, lots of open ends that need to be 3

assimilated and summarized, which will be the work of 4

the next several months.

5 Are there any other further comments 6

before we adjourn?

7 MS. HOLIDAY: Dr. Alderson, this is 8

Sophie again.

9 Just as I

did during the last 10 teleconference call, I would like to thank the 11 Committee for their time on reviewing this topic and 12 discussing it, including members of the public who 13 also participated.

14 I'd also like to remind everybody that 15 the ACMUI will be holding its spring meeting here at 16 NRC Headquarters next Wednesday and Thursday. We 17 look forward to having all of you here at Headquarters 18 and participation via webinar.

19 Thank you.

20 CHAIRMAN ALDERSON: Okay. Thank you 21 very much.

22 I think, hearing no other comments, 23 unless there are any, I think we will stand adjourned.

24 (Whereupon, at 3:49 p.m., the Committee 25

84 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 was adjourned.)

1

Statementof TheAmericanSocietyforRadiationOncology(ASTRO)

BeforetheNuclearRegulatoryCommissionsAdvisoryCommitteeontheMedicalUseofIsotopes March1,2018

ChairmanAlderson,membersoftheACMUIandNRCstaff,thankyouforallowingmetoprovidethis statement on behalf of the American Society for Radiation Oncology (ASTRO) in response to the SubcommitteeonTrainingandExperienceforallModalitiesreportdiscussedtoday.

ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specializeintreatingpatientswithradiationtherapies.Astheleadingorganizationinradiationoncology, biologyandphysics,theSocietyisdedicatedtoimprovingpatientcarethrougheducation,clinicalpractice, advancementofscienceandadvocacy.ASTROshighestpriorityhasalwaysbeenensuringpatientsreceive thesafest,mosteffectivetreatments.

AswestatedinourOctober7,2016statementtotheACMUI,westronglyopposeanyreductioninthe training and experience (T&E) requirements found in 10 CFR 35.390, Training for use of unsealed byproductmaterialforwhichawrittendirectiveisrequired.Underthissection,the NRC requiresan authorizeduser(AU)tobecertifiedbyamedicalspecialtyboardrecognizedbyeithertheNRCoran agreementstate,orhascompleted700hoursofT&Einbasicradionuclidehandlingtechniquesapplicable tothemedicaluseofunsealedbyproductmaterialrequiringawrittendirective.ASTRObelievesthat theserequirementsareappropriate,protectthesafetyofpatients,thepublic,andpractitioners,and shouldnotbechanged.Radiopharmaceuticalsarehighlyeffectiveintreatingcancer,butalsopotentially hazardousdrugswithpossibleharmfuleffectstoboththepatientandthepublicifnotusedcorrectlyand underthesupervisionofahighlytrainedphysician.

TherigorousT&Erequirementscontributetotheexcellentsafetyrecordofradiopharmaceuticals.We believethatitisimportantthatthepersonadministeringtheradiopharmaceuticalisappropriatelytrained inthesafehandling,exposurerisks,andthemanagementofsideeffectsofradiation.

Initsreport,theSubcommitteeexpressesconcernswiththedeclineinthenumberofnuclearmedicine physicianssittingfortheCertificationExaminationoftheAmericanBoardofNuclearMedicine.However, theSubcommitteedoesnotdiscussotherAUs,includingradiationoncologists.TheAmericanBoardof Radiology(ABR)estimatesthatbetween2007and2017,approximately1,650radiationoncologistshave beencertifiedbytheABRwithanAuthorizedUserEligibilitydesignationandmaybecomeAuthorized Users.Inaddition,ASTROestimatesthatthereareapproximately2,200radiationoncologyfacilitiesinthe UnitedStates,whichmeansasidefromthenuclearmedicinetrainedAUsnationwide,therearelikely enoughAUsjustamongtheradiationoncologists.Indeed,ASTROisnotawareofaperceivedshortageof radiationoncologistsanywhereinthecountry.However,withoutbeingabletoidentifywhichAUsare licensedunder35.390and35.300,itisnotpossibletoconfirmwhetherthereisanactualAUshortage,or justaperceivedone.Additionally,ASTROhasnotheardwhatwouldbeanidealnumberofAUs.ASTRO membersarereadytocareforpatientsneedinganyradiopharmaceutical.

Inconclusion,forthereasonsstatedabove,ASTROopposesareductionintheT&Erequirementsfor10 CFR35.390andlooksforwardtoprovidinginputtotheSubcommitteeasitcontinuesitsdeliberations.

February 28, 2018 U.S. Nuclear Regulatory Commission (NRC) 11555 Rockville Pike Rockville, MD 20852 Washington, DC 20555-0001 Re: Training and Experience Requirements

Dear members of the ACMUI:

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) appreciates the opportunity to provide comments on the Subcommittees Draft Interim Report. SNMMIs more than 17,000 members set the standard for molecular imaging and nuclear medicine practice through the creation of clinical guidelines, sharing evidence-based medicine through journals and meetings, and leading advocacy on key issues that affect molecular imaging and therapy research and practice. SNMMI is pleased to offer comments on specific topics detailed below.

The Society of Nuclear Medicine and Molecular Imaging continues to believe that reducing the number of hours of training requirements to any less than 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> will significantly compromise the level of care for the patients receiving these treatments. We understand however that the ACMUI would appreciate a more detailed description of the training and experience that authorized users need. We will develop more detailed recommendations and expect to submit them to you in late June. We hope this will provide the subcommittee with enough time to consider our recommendations before the ACMUIs next meeting in the Fall.

As you are aware, clinical nuclear medicine practice requires not only deep fundamental knowledge of radiation biology and radiation safety but also of indications, contraindications and safety precautions of these treatments. In addition, the administering physician needs to be fully prepared to handle any minor or major radiation spills that may have patient and health personnel safety implications as well as major regulatory implications at the local, state and federal levels.

SNMMI appreciates the opportunity to comment on this report and looks forward to working with you as this process moves forward. As always, SNMMI is ready to discuss any of its comments or meet with NRC on the above issues. In this regard, please contact Caitlin Kubler, Senior Manager, Regulatory Affairs, by email at ckubler@snmmi.org or by phone at 703-326-1190.

Sincerely, Bennett S. Greenspan, MD, FACNM, FACR President, SNMMI

1 Carol S. Marcus, Ph.D., M.D.

1877 Comstock Avenue Los Angeles, CA 90025-5014

<csmarcus@ucla.edu>

Feb. 21, 2018 Advisory Committee on Medical Uses of Isotopes (ACMUI)

U.S. Nuclear regulatory Commission 11555 Rockville Pike Rockville, MD 20852 c/o Ms. Sophie Holiday, Sophie.Holiday@nrc.gov

Dear Ms. Holiday and Members of the ACMUI:

Thank you for the opportunity to comment on the subject of training and experience (T&E) requirements for physicians to practice nuclear medicine therapy. I shared some of my thoughts with Dr. Metter on March 30, 2017, and will repeat some of my points here for the record.

Let me begin with a theoretical story to make the point that licensing physicians to do bits and pieces of nuclear medicine is a huge mistake.

Let us imagine that Dr. Brown takes a two week course in how to perform appendectomies and then goes to his hospital administrator wanting practice privileges to perform appendectomies.

The hospital administrator agrees. Dr. White takes a two month course in how to perform hernia repairs, and asks the same hospital administrator for practice privileges to perform hernia repairs.

The hospital administrator agrees. Dr. Black takes a one month course in how to perform cholecystectomies, and asks the same hospital administrator for practice privileges to perform cholecystectomies. The hospital administrator agrees. Dr. Green takes a four month course in how to perform lumpectomies and mastectomies, and asks the same hospital administrator for practice privileges to perform lumpectomies and mastectomies. The hospital administrator agrees. Drs. Brown, White, Black, and Green are family practice physicians, and when any of their patients come in with need of any of these procedures, they recommend themselves or each other to perform them. There was a board certified general surgeon on staff, but as his bread and butter business began melting away, he left and went elsewhere to practice. One night there is a

2 terrible auto accident, and severely injured victims are brought to the hospital. There is no general surgeon available to help these patients, and they die. This is theoretical of course, because physicians are not given practice privileges to practice bits and pieces of general surgery. Generally speaking a physician must be board certified in general surgery to get practice privileges in general surgery. He/she may opt to specialize in breast surgery, or endocrine surgery, etc., but must be educated, trained, and experienced in all of general surgery. He/she may then opt to generally restrict his/her practice any way he/she wishes to do so.

This is generally the case with all medical specialties. One cannot become a cardiologist, endocrinologist, pulmonologist, infectious disease expert, nephrologist, etc. without first becoming a general internist. Medical education, training, and experience start out broadly, and then become subspecialized. This is true of all medical specialties except nuclear medicine, and to my knowledge, only in the United States. What happened in the United States to cause a balkanization of nuclear medicine?

Part of the story is historical, part is political, and part is economic. Nuclear medicine began in the United States in 1936 with the use of P-32 sodium phosphate to treat polycythemia rubra vera. Before WWII, radionuclides were accelerator produced and their medical use was not regulated by anyone except generally by State Boards of Medicine. After WWII ended, I-131 sodium iodide was produced in the Oak Ridge reactor and became available for treating hyperthyroidism and differentiated thyroid cancer. Due to the fact that there was no specialty called nuclear medicine, the fledgling Atomic Energy Commission ran a two week course in how to use I-131 sodium iodide to treat hyperthyroidism and differentiated thyroid cancer, and established an Advisory Committee on Medical Uses of Isotopes (ACMUI) to determine what radiopharmaceuticals could be used by physicians to diagnose and treat which conditions. At that time the FDA did not regulate radiopharmaceuticals (they didnt until 1975). When the Atomic Energy Commission was divided up into what became the Department of Energy (DOE) and the Nuclear Regulatory Commission (NRC), the ACMUI was retained by the NRC. When nuclear medicine finally became established as a board certifiable specialty, the NRC asked the ACMUI if NRC should restrict nuclear medicine licensure to physicians board certified in nuclear medicine. Due to the fact that there were many physicians practicing nuclear medicine who didnt take the early boards, the ACMUI decided against recommending a requirement for board certification in nuclear medicine in order to be licensed to practice it. As time went on, more and more board certified nuclear medicine physicians took positions in hospitals and in private practice.

The downturn in the building of nuclear power plants took place after the Three Mile Island accident in 1979, and the NRC looked to medicine to increase its regulatory activities. Then Congress put a User Fee provision into a law and the NRC had to raise its whole operating budget with User Fees, except for International Programs, which at the time was about 10% of its budget. The User Fee requirement stated that each class of NRC licensees had to take care of its own regulatory program. NRC could not use User Fees from the nuclear power side to fund its Medical Program, for example. NRC had hired many employees for its Medical Program, and its medical User Fees were high. The next year NRC tried to raise the fees even higher, and the

3 nuclear medicine community went to Congress and complained bitterly. The House Oversight Committee told NRC it could not raise its Medical User Fees.

The NRC was faced with two choices: lay off extraneous staff to keep the User Fees low, or sell more radioactive materials licenses in the medical sector to support its bureaucracy. It doesnt take a rocket scientist to figure out what happened. NRC started chopping up nuclear medicine into bits and pieces and selling more licenses. But the perfect storm occurred when Congress started putting the squeeze on hospital reimbursement. Hospital administrators were forced to cut costs wherever possible. So as cardiologists could be licensed to do nuclear cardiology, and diagnostic radiologists could be licensed to do diagnostic imaging and nuclear medicine therapy, and radiation oncologists could be licensed to do nuclear medicine therapy, the hospital administrators insisted that they do so and then laid off their board certified nuclear medicine physicians, or did not replace them when they left or retired. Today there are very few positions for board certified nuclear medicine physicians in the United States except for academic medicine. Most community hospitals will not take on a nuclear medicine physician unless he/she is also board certified in diagnostic radiology. Fewer medical school graduates choose nuclear medicine as a specialty, and nuclear medicine residency programs began decreasing.

While the field is in good shape, the specialty is dying. At present we are down to 42 residency programs in the United States, with a total of 69 residents, 72.5% of whom are foreign medical graduates (1). And because of all this, the quality of nuclear medicine is often poor. Many radiologists and cardiologists expect their technologists to practice nuclear medicine, even to the point of reading out the scans, and no technologist is capable of practicing nuclear medicine.

Many nuclear cardiologists contract out the reading of their scans to board certified nuclear medicine physicians, because the cardiologists are not competent to do so. The NRC, which purportedly increased its regulation of nuclear medicine to keep America safe, has been the driving force in decreasing the safety of American patients by imposing poor quality nuclear medicine practice on them. The patients are not endangered by the radiation in nuclear medicine. They are endangered because the studies are not optimally varied for individual patients with differing diagnostic questions, because the nuclear medicine physician does not even see the study until the end of the day when the tech has decided on the procedure and the patient is gone. The creativity in devising diagnostic nuclear medicine studies to get at difficult problems is gone. Many diagnostic procedures are misread or incompletely read. Most research and development in the United States is gone---just look at the Journal of Nuclear Medicine and see how most of the papers are coming in from other countries. Nuclear medicine technologist training programs run by nuclear medicine departments in hospitals are closing---the diagnostic radiologists have no interest or expertise to keep them going.

The situation with nuclear medicine therapy is even more problematic. Other than the use of Na I-131 to treat hyperthyroidism, all therapies at present are for cancer patients. Nuclear medicine therapies have side effects, sometimes moderate or severe, and many of the cancer patients are very ill, in pain, and have had prior treatments with chemotherapy, surgery, and/or radiation therapy. The patients and the patients families have many questions, and physicians with minimal education, training, and experience often cannot answer their questions. Many of these physicians dont even want to talk to their patients and tell their technologists to take care of it.

Technologists are unqualified to do so. A thyroid cancer survivor group apparently started by Peter Crane, a retired NRC lawyer, has complained to NRC about poor quality nuclear medicine

4 therapy care, expecting the NRC to fix the problem by regulation. Efforts by the NRC, with no medical competence whatsoever, to tell physicians how they must practice nuclear medicine are terrible. The problem is that these poorly competent physicians should not be practicing nuclear medicine therapy in the first place. My experience is that the worst group here is the diagnostic radiologists with no special training other than the supposed four month requirement for nuclear medicine during their diagnostic radiology residency. The radiation oncologists are generally somewhat better, but they usually have little training and experience as well. While theoretically each group receives 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, as promised by memos of understanding between their boards and the NRC, I think that it is highly unlikely that many of the residency programs for these groups actually offer such training, and that residents often do not attend many of the lectures and practice opportunities that are offered. To my knowledge, NRC has never inspected any of these programs to check whether residents actually receive 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training, and it might be a good idea for them to do so, and to check whether the residents actually come to the training offered. In January of 2018 Lu-177 Lutathera was approved by FDA for neuroendocrine tumors, and clinical trials are ongoing for Lu-177 prostate specific membrane antigen (for prostate cancer). These therapies can have significant side effects, and competent physicians must be present to take care of the patients. The problem of quality of the nuclear medicine therapy procedures may well worsen.

When I was on the ACMUI we unanimously voted to end the 80 hour9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> T&E program for endocrinologists to use any quantity of I-131 NaI for hyperthyroid and thyroid cancer therapy.

However, when NRC redid the medical regulations in 1997 it chose to ignore the ACMUI. In addition, the ACMUI unanimously voted to require a comprehensive examination in basic nuclear and radiation sciences for physicians who supposedly met the T&E requirements, to make certain that they actually internalized the needed information. The first draft of the 1997 regulations contained that requirement, but mysteriously disappeared in the final regulations with the lame excuse that making up a different examination for each group of nuclear medicine physicians was too difficult. The ACMUI never suggested a different examination for each group of physicians; only one examination was envisioned. However, it appears that the NRC realized that many of its authorized user physicians could not pass such an examination, and it would then lose the User Fees from these physicians, and that would mean laying off staff in the Medical Program.

It appears that some physicians in medical specialties that do not now have T&E programs for nuclear medical therapy are looking at profits from performing these therapies and want a limited T&E program like the endocrinologists have. Their excuse is patient access. I am absolutely opposed to this. It would only make the problem worse. There is no limit to how low medical quality can sink, and we do not need a regulatory agency that purports to improve safety to continue to lower medical quality.

So, what do we do to fix this T&E mess? The NRC needs to end the chopping up of nuclear medicine into multiple pieces and end the licensing of non-board certified nuclear medicine physicians for any of those pieces. This would restore a critical mass of procedures to a board-certified nuclear medicine physician, justifying a full-time person performing these procedures.

After all, in radiation oncology the NRC requires board-certification in radiation oncology to perform any procedures using byproduct material (brachytherapy and some large sources in

5 Gamma Knife type procedures and I suppose a few Co-60 machines, although these are mainly defunct now). Why require board certification in radiation oncology but not nuclear medicine?

Politics and money! The radiation oncology groups fought like cats when NRC was thinking about removing the requirement for board certification. Unfortunately, nuclear medicine has not yet mounted such a fight. That is not a reason to destroy the specialty of nuclear medicine.

The use of unsealed radioactive material for nuclear medicine therapy is likely more dangerous than the use of sealed byproduct sources in radiation oncology.

A change such as this will take some time, so that more residents enter nuclear medicine and are available to be hired, replacing the part-time practitioners taking bits and pieces of nuclear medicine today. This could probably be accomplished over a 5-10 year period. In every first world country, and even a third world country like India, all nuclear medicine is practiced by board-certified nuclear medicine physicians. The United States is an outlier. We really do not need the NRCs Medical Program. In 1995, when the National Academy of Sciences Institute of Medicine (NAS-IOM) studied NRCs Medical Program under contract with the NRC, the NAS-IOM determined that NRCs Medical Program (including radiation oncology as well as nuclear medicine) was so dysfunctional, and such a danger to patients, that it recommended that Congress remove NRCs statutory authority in all of medicine and medical research. The standard of medical practice is determined by the specialties of nuclear medicine and radiation oncology, not the NRC. We do not need the NRC Medical Program at all. A requirement that any or all of nuclear medicine be practiced by board-certified nuclear medicine physicians and a continuation of the requirement that any or all of radiation oncology be practiced by board-certified radiation oncologists would replace all of Part 35, including all the NRCs Medical Program staff. This needs to be accomplished by the NRC Commissioners, and perhaps the Congress. But, for the benefit of patients, it is high time that it was accomplished.

Thank you for your attention and consideration.

Sincerely, Carol S. Marcus, Ph.D., M.D.

Prof. of Molecular and Medical Pharmacology (Nuclear Medicine), of Radiation Oncology, and of Radiological Sciences (ret.), David Geffen School of Medicine at UCLA

References:

(1) Barzansky B and Etzel S: Medical schools in the United States. JAMA 318(23):2370, 2017.

NRC T&E for Tx-Comments for ACMUI 03-01-18