1 department of health and human services




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1 DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

BLOOD PRODUCTS ADVISORY COMMITTEE SIXTY-SIXTH MEETING

VOLUME I

Thursday, June 15, 2000

8:00 a.m.

Holiday Inn 8777 Georgia Avenue

Silver Spring, Maryland


2 P A R T I C I P A N T S

F. Blaine Hollinger, M.D., Chairman

Linda Smallwood, Ph.D., Executive Secretary

MEMBERS:

John M. Boyle, Ph.D.

Mary E. Chamberland, M.D.

G. Michael Fitzpatrick, Ph.D.

Richard J. Kagan. M.D.

Marion A. Koerper, M.D. Jeanne V. Linden, M.D. B. Gail Macik, M.D. Mark A. Mitchell, M.D.

Kwaku Ohene-Frempong, M.D. Terry V. Rice

Paul J. Schmidt, M.D.

NON-VOTING REPRESENTATIVES:

Katherine R. Knowles, Consumer Representative Toby L. Simon, M.D., Industry Representative

TEMPORARY VOTING MEMBERS:

Paul R. McCurdy, M.D.

Kenrad E. Nelson, M.D. Carmelita U. Tuazon, M.D.


3 C O N T E N T S

Conflict of Interest Statement, Linda Smallwood, Ph.D. 5

Committee Updates:

Summary of PHS Advisory Committee on Blood Safety and Availability, Stephen Nightingale, M.D. 8

Summary of Workshop on Plasticizers: Scientific

Issues in Blood Collection, Storage and Transfusion,

Jaroslav Vostal, M.D., Ph.D. 18

Report on Blood Supply Monitoring, Paul McCurdy, M.D. 26

Summary of Transmissible Spongiform Encephalopathies Advisory Committee Meeting, David Asher, M.D. 36

Plasma Pool Screening by Nucleic Acid Tests:

Introduction and Background, Robin Biswas, M.D. 46

Regulatory Options for HAV NAT, Sheryl Kochman 57

Review of History of Hepatitis A Transmitted by Transfusion, Mahmood Farshid, Ph.D. 70

Hepatitis A Virus: Epidemiology/Clinical Implications/Prophylaxis, Stephen Feinstone, M.D. 83

HAV Transmission by Factor VIII Concentrates,

Dr. Michael Chudy 102

Open Public Hearing:

Louis Katz, M.D., American Association of Blood Banks 108 Susan Stramer, Ph.D., American Red Cross 111

Open Committee Discussion:

FDA Perspective and Questions 127

Open Public Hearing:

Afzal Chowdhury, Ph.D.,

Guardian Scientific, Inc. 153


4 C O N T E N T S(Continued)

Development of Rapid HIV Tests:

Background and Introduction,

Kimber Lee Poffenberger, Ph.D. 158

Presentation by Robert S. Janssen, M.D.,

Division HIV/AIDS 171

Presentation by Lt. Hassan S. Zahwa, DOD 180

Presentation by Nancy A. Wade, M.D., M.P.H.,

NYS Department of Health 198

Presentation by Robert S. Janssen, M.D.,

Division HIV/AIDS 210

Open Public Hearing (Continued):

Bill Murray, Abbott Laboratories 237

Scott Dennis, Bio-Rad Laboratories 241

Hermes Chan, MedMira 247

Raymond Smith, National Alliance of State and

Territorial AIDS Directors 252

Open Committee Discussion and

Questions for the Committee 257


5 1 P R O C E E D I N G S

2 Conflict of Interest

3 DR. SMALLWOOD: The following announcement is made

4 a part of the public record to preclude the appearance of a

5 conflict of interest at this meeting. Pursuant to the

6 authority granted under the Committee Charter, the Director

7 of the FDA's Center for Biologics Evaluation and Research

8 has appointed Dr. Kenrad Nelson as a temporary voting

9 member, and the Senior Associate Commissioner for the Food

10 and Drug Administration has appointed Dr. Carmelita Tuazon

11 as a temporary voting member for the discussions on the

12 development of rapid HIV tests.

13 To determine if any conflicts of interest existed,

14 the agency reviewed the submitted agenda and all relevant

15 financial interests reported by the meeting participants.

16 In the event that the discussions involve other products or

17 firms not already on the agenda for which FDA's participants

18 have a financial interest, the participants are aware of the

19 need to exclude themselves from such involvement and their

20 exclusion will be noted for the public record.

21 With respect to all other meeting participants we

22 ask in the interest of fairness that you state your name,

23 affiliation and address any current or previous financial

24 involvement with any firm whose products you wish to comment

25 upon. If there are any declarations to be made at this


6 1 time, we will accept those. If not, then I will move

2 forward with making a few announcements at this time.

3 First, I would like to introduce the members of

4 the Blood Products Advisory Committee. When I call your

5 name, members, would you please raise your hand? First we

6 will begin with Dr. Blaine Hollinger who is the Chairperson,

7 Dr. John Boyle, Dr. Jeanne Linden, Dr. Ohene-Frempong, Dr.

8 Gail Macik, Dr. Paul Schmidt, Dr. Michael Fitzpatrick, Miss

9 Kathy Knowles, Dr. Toby Simon, Dr. Mary Chamberland, Mr.

10 Terry Rice, Dr. Marion Koerper, Dr. Richard Kagan, Dr. Paul

11 McCurdy.

12 Absent from this meeting are Dr. Norig Ellison,

13 Dr. Daniel McGee, Dr. David Stroncek and Dr. Sherri Stuver.

14 We will have with us for this meeting, as temporary voting

15 members, Dr. Carmelita Tuazon and Dr. Kenrad Nelson, and we

16 will also have as a guest of the committee Dr. Raymond Koff.

17 I would just like to announce that out on the

18 table there is information regarding a workshop on

19 recruiting blood donors. It will occur July 6th and 7th.

20 You may pick up that information at the table outside.

21 So that our proceedings will move smoothly, we are

22 asking that cell phones preferably be turned off, however,

23 if you must have them, that they be turned down low so that

24 the ringing will not interfere with the proceedings. Also,

25 if you would be mindful that we have a full agenda today so


7 1 that all speakers will be prepared to speak when called upon

2 and that you will adhere to the time frames that we have

3 allotted.

4 At this time I would like to turn over the

5 proceedings of the meeting to the Chairperson, Dr. Blaine

6 Hollinger.

7 DR. HOLLINGER: Thank you, Dr. Smallwood.

8 Welcome, everybody. We have a very busy day and a half.

9 The last meeting I attended was a few weeks ago, where Paul

10 Brown was chairing the meeting. I noticed that he had a

11 gavel and I told Linda that I needed a gavel up here.

12 [Laughter]

13 We do have a busy meeting today. We are going to

14 have several updates, both to start off this morning as well

15 as tomorrow morning. The two major topics today -- one is

16 going to be on the potential for plasma pool screen by

17 nucleic acid testing for HAV. There will be some questions

18 about that, and potential recommendations from the

19 committee. This afternoon will be pretty much devoted to

20 HIV rapid testing, again with some recommendations and

21 discussions from the committee. Then, tomorrow there will

22 be a session on leukoreduction, again with the same format.

23 Since we do have a big morning, we are going to

24 start off with the committee updates, and the first

25 committee update will be a summary of the PHS Advisory


8 1 Committee on Blood Safety and Availability meeting which was

2 held April 25th and 26th, and Dr. Nightingale is going to

3 give us an update.

4 Committee Updates

5 Advisory Committee on Blood Safety and Availability

6 DR. NIGHTINGALE: Good morning and thank you. Dr.

7 Hollinger, I don't think that you will need to use that

8 gavel for me because as soon as my presentation is completed

9 my vacation begins.

10 [Laughter]

11 The advisory committee did meet on April 24th and

12 25th, and it made five recommendations. When I spoke to you

13 in March I indicated that our deliberations on error and

14 accident management in transfusion medicine were continuing.

15 The first of the five recommendations made by the advisory

16 committee is lengthy but uncommonly literate for advisory

17 committee recommendations. I will, nevertheless, refrain

18 from reading it to you in its entirety but the meat of the

19 issue is as follows:

20 The advisory committee recommended that error

21 management systems should acknowledge the rights of patients

22 to know of any risk or harm suffered as a consequence of any

23 error or accident related to blood products received. At

24 the same time, there should be statutory protection from

25 disclosure for voluntarily reported information and quality


9 1 assurance activities that are not associated with potential

2 or actual harm, provided that the information is also not

3 associated with reckless or intentionally harmful acts.

4 These error management systems should complement

5 and not replace current regulatory activities, notably but

6 not exclusively, in the area of product safety. All

7 analyses of collected data should be made available in a

8 timely manner to regulatory agencies, national transfusion

9 medicine surveyance programs and other participants in

10 reporting systems.

11 While I think the god or the devil is in the

12 details, the feeling within the advisory committee is that

13 its immediate charge was accomplished to lay a framework for

14 ways to support the implementation of more effective error

15 management programs.

16 In a brief paragraph of this recommendation, the

17 advisory committee recommended that Congress should

18 appropriate sufficient funds to develop these systems and

19 for infrastructure sufficient to support and maintain them.

20 In the Fiscal Year 2001 budget, Congress should stipulate

21 that these funds should not be reallocated for other

22 purposes and that no other funding should be reduced because

23 of the availability of these funds. Funds necessary to

24 maintain these systems should be appropriated annually.

25 I know that Dr. Hollinger receives a copy of all


10 1 the mailings of the advisory committee, and I believe that

2 they are, or certainly can be, distributed to the other BPAC

3 members. For the public, these are available on our web

4 site, which is www.dhhs.gov/bloodsafety. The web site is

5 slightly less clunky than its predecessor.

6 The advisory committee made four other

7 recommendations, and the second and third are also directed

8 at Congress. Although I believe the advisory committee was

9 aware that it is the Secretary of Health and Human Services

10 and not Congress that it advises, nevertheless, the Congress

11 is interested in the deliberations and these have been

12 communicated to the Congress.

13 The second of these recommendations was that there

14 is a small but non-zero risk associated with the use of

15 blood products or plasma derivatives that cannot be

16 eliminated with current technology. The advisory committee,

17 therefore, supports the prior recommendation of the

18 Institute of Medicine and of others that a prospective

19 national system to compensate recipients for injuries or

20 death caused by blood products or plasma derivatives, and

21 not associated with reckless or intentionally harmful acts,

22 should be enacted and funded by Congress.

23 This is clearly a complex issue. The Institute of

24 Medicine and others have previously recommended it. Of

25 course, the details here that the advisory committee did not


11 1 address are how to identify who should be compensated and

2 what is just compensation. So, I don't anticipate immediate

3 reaction to it but this is clearly, like the first issue, an

4 issue that goes beyond the scope of either the advisory

5 committee itself or, for that matter, we believe the

6 Department. So, this at the moment was directed to Congress

7 for further action and we will see, in an election year and

8 afterwards, what becomes of it.

9 The third of the five recommendations is of

10 substantial interest to the blood community. To summarize,

11 there is a "whereas" at the beginning -- safety and

12 availability is dedicated to ensuring patient access -- it

13 goes on though -- the advisory committee, consistent with

14 prior recommendations, recommends that the Secretary and

15 Congress support legislation to ensure fair and accurate

16 reimbursement for inpatient blood-related products and

17 services. Such legislation should provide sufficient

18 funding to account for increased blood-related costs,

19 including those associated with new blood safety measures,

20 and require that these costs be reflected in annual updates

21 of inpatient diagnosis related groups.

22 Again, this is a complex recommendation. I think

23 the advisory committee has stated its position and from this

24 point on it is for the Congress and the Executive Branch to

25 take further action.


12 1 The fourth of the five recommendations, the
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