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U.S. FOOD AND DRUG ADMINISTRATION

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U.S. FOOD AND DRUG ADMINISTRATION

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     U.S. FOOD AND DRUG ADMINISTRATION

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     OFFICE OF THE COMMISSIONER

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     SCIENCE BOARD

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     MEETING

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     FRIDAY,

     NOVEMBER 5, 2004

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     The meeting was held at 8:00 a.m. in Room 1066 of the Food and Drug Administration, 5630 Fishers

    Lane, Rockville, Maryland, Dr. Kenneth I. Shine, Chair, presiding.

PRESENT:

     KENNETH I. SHINE, M.D., Chair

     GAIL H. CASSELL, Ph.D., Member

     JOSEPHINE GRIMA, Ph.D., Consumer

     Representative

     SUSAN KAY HARLANDER, Ph.D., Member

     CATO T. LAURENCIN, M.D., Ph.D., Member

     CECIL B. PICKETT, Ph.D., Member

     F. XAVIER PI-SUNYER, M.D., M.P.H., Member

     JIM E. RIVIERE, D.V.M., Ph.D., Member

     ALLEN D. ROSES, M.D., Member

     KATHERINE M.J. SWANSON, Ph.D., Member

     JOHN A. THOMAS, Ph.D., Member

     LESTER M. CRAWFORD, D.V.M., Ph.D., Acting

     Commissioner

     NORRIS E. ALDERSON, Ph.D., Associate

     Commissioner for Science

     JAN N. JOHANNESSEN, Ph.D., Executive Secretary

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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     I-N-D-E-X

    AGENDA ITEM PAGE

    Call to Order 5 Kenneth I. Shine, M.D., Chair, FDA Science Board

    Meeting Statement 5 Jan N. Johannessen, Ph.D., Executive Secretary

    Welcome and opening remarks 7 Lester M. Crawford, D.V.M., Ph.D., Acting

    Commissioner of Food and Drugs

    Update on the Critical Path Initiative 23

    CDER Critical Path Activities 23 Douglas Throckmorton, M.D., Center for Drug Evaluation and Research, FDA

    CBER Critical Path Activities 44 Kathryn Carbone, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA

    CDRH Critical Path Activities 59 Daniel Schultz, M.D., Director, enter for

    Devices and Radiological Health, FDA

    Overview of Critical Path Docket Submissions 74 Lisa Rovin, J.D., Director, Critical Path

    Initiative, Office of the Commissioner, FDA

    Critical Path - Current Activities and the 88 Path Forward

    Janet Woodcock, M.D., Acting Deputy

    Commissioner for Operations, FDA

    Medical Technology Innovation Task Force 107 Larry G. Kessler, Sc.D., Director, Office of Science and Engineering Laboratories

    Foods Critical Path White Paper 118 Alan M. Rulis, Ph.D., Senior Advisor for

    Special Projects, Center for Food Safety and Applied Nutrition, FDA

    Questions and Discussion with the 127 Board/Presenters

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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     I-N-D-E-X (Continued)

    AGENDA ITEM (Continued) PAGE

    Open Public Hearing 173

    Pharmaceutical cGMP Initiative 173 Janet Woodcock, M.D., Acting Deputy

    Commissioner for Operations, FDA

    Final Report on Process Analytical 204 Technology and Manufacturing Science

    Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Sciences, CDER, FDA

    ORA Peer Review - Overview of Report and Plan 245 for External Peer Review

    John R. Marzilli, Deputy Associate Commissioner for Regulatory Affairs, FDA

    Questions and Discussion with Board - 276 Recommendations

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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    1 P-R-O-C-E-E-D-I-N-G-S

    2 (8:00 a.m.) 3 CALL TO ORDER

    4 CHAIRMAN SHINE: Good morning, ladies and 5 gentlemen. I'm Ken Shine. I currently serve as Chair 6 of this advisory committee, and I would like to call 7 the meeting to order.

    8 Our Executive Secretary, Jan Johannessen, 9 has a number of duties that he has to perform. So 10 I'll turn the microphone over to Jan.

    11 EXECUTIVE SECRETARY JOHANNESSEN: Thank 12 you.

    13 MEETING STATEMENT

    14 EXECUTIVE SECRETARY JOHANNESSEN: I would 15 like to read the meeting statement. "The following 16 announcement addresses conflict of interest with 17 respect to with this meeting and is made part of the 18 public record to preclude even the appearance of such 19 at the meeting.

    20 "The Food and Drug Administration has 21 prepared general matters waivers for Drs. Shine, 22 Pickett, Grima, Riviere, Laurencin, Swanson, Thomas, 23 Roses, Pis-Sunyer, Cassell, and Harlander. A copy of 24 the waiver statements may be obtained by submitting a 25 written request to our Freedom of Information Office.

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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    1 "The waivers permit them to participate in 2 the Committee's discussion of the FDA's Critical Path 3 Initiative and related topics, cGMP reports, and the 4 peer review of the Office of Regulatory Affairs 5 Pesticide Program.

    6 "The topics of today's meeting are of 7 broad applicability. And unlike issues before a 8 committee in which a particular product is discussed, 9 issues of broader applicability involve many 10 industrial sponsors and academic institutions. 11 "The participating Committee members have 12 been screened for their financial interests as they 13 may apply to these general topics at hand. Because 14 the general topics impact so many institutions, it is 15 not prudent to recite all potential conflicts of 16 interest as they apply to each participant. 17 "The FDA acknowledges that there may be 18 potential conflicts of interest, but because of the 19 general nature of the discussion before the Committee, 20 these potential conflicts are mitigated."

    21 We have an open public comment scheduled 22 for 1:00 p.m. I would just remind everyone to turn 23 your microphones on when you speak so that the 24 transcriber can pick everything up.

    25 And I just wanted to make a note that Dr.

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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    1 Throckmorton has to leave immediately after his 2 presentation to catch a plane.

    3 Thank you.

    4 CHAIRMAN SHINE: Thank you, Jan. That is 5 an even more important reason for us to start on time. 6 (Laughter.)

    7 CHAIRMAN SHINE: We are pleased to have 8 the Acting Commissioner of Food and Drugs, Dr. 9 Crawford, to make some opening remarks. Lester? 10 DR. CRAWFORD: Thank you.

    11 WELCOME AND OPENING REMARKS

    12 DR. CRAWFORD: Well, first of all, let me 13 thank all of you for being here and giving of your 14 time for this all-important undertaking. I will 15 discuss a little bit more about the elements of the 16 undertaking a little bit later.

    17 First I have to say that Dr. Throckmorton 18 is not going to be catching a plane. He's going to 19 stay here. It's not approved. Any questions, Dr. 20 Throckmorton? Thank you.

    21 (Laughter.)

    22 DR. CRAWFORD: Now, the next thing is I 23 would like Dr. Pickett to step forward, please. Dr. 24 Pickett, as all of you know, has been both a faithful 25 and intellectually stimulating and hard-working and

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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    1 well-prepared member of the Committee all of the time 2 that he has been on it. This happens to be what he 3 thinks will be his last meeting.

    4 In recognition of the fact that he will 5 come back, just like MacArthur, we have a nice plaque 6 here, which says, "In recognition of distinguished 7 service, the Science Board of the Food and Drug 8 Administration, Office of the Commissioner from August 9 2001 to December 2004."

    10 And, Cecil, you will agree that those 11 three years seemed like the twinkling of an eye, 12 right?

    13 MEMBER PICKETT: Absolutely. Thank you 14 very much.

    15 (Applause.)

    16 DR. CRAWFORD: It is usual and traditional 17 for the commissioner at this point to give an update 18 on what is happening in FDA. And, in addition to the 19 agenda, I want to talk about some regulatory 20 developments that we're going to be rolling out by the 21 end of this presidential term.

    22 For some months, starting with a National 23 Press Club speech on August 2 of this year, we 24 indicated that we were going to wrap up all of the 25 different things that we had promised to do in terms

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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    1 of regulatory changes that will improve FDA's ability 2 to advance public health and also to prevent unwanted 3 diseases and adverse reactions; in other words, 4 changing to the new FDA that was envisioned during the 5 time that Dr. McClellan and I were working together. 6 And, as he was leaving to go on to different pastures, 7 we indicated together that we would work hard to get 8 these things done and done by the end of this 9 presidential term.

    10 I started at that point using the term 11 "the end of this administration." I was admonished by 12 some people in the administration that that might not 13 be the best choice of words. So I modified. And now 14 we're using the term "presidential term."

    15 This particular week several things have 16 happened which are important. We have completed the 17 single-use devices review. That's part of an overall 18 review of medical devices in terms of their reuse 19 capability and a determination of what would 20 constitute the criteria for single use.

    21 The bioterrorism regulations, which, as 22 you may recall, were in four categories, have now been 23 completed. And we issued also this week Prior Notice 24 regulations. In other words, a provision of the law 25 of 2002 was that companies that were going to export

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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    1 products to the United States had to give us the 2 privilege of knowing that they were coming. 3 The game of product roulette that had been 4 going on for decades was officially over when the 5 president signed the law in June of 2002. It awaited, 6 though, final clarification with the regulations. We 7 had some spirited review. And so we modified the 8 regulations and represented them. And now they're 9 gone forward.

    10 The second one is registration. When 11 Secretary Thompson attempted to deal with, number one, 12 the 2001 9/11 disaster; and, number two, the anthrax 13 problem; and, number three, the possibility that the 14 next terrorist attack would be through the food 15 supply, he was chagrined and alarmed to know that he 16 did not have the capability of stopping products at 17 the border or requiring registration of firms that 18 manufactured in the United States or manufactured 19 elsewhere and exported to the U.S. So the passage of 20 the law was of great benefit to bioterrorism, as the 21 law implies.

    22 Registration does require registration of 23 those facilities. And FDA will require that on an 24 annual basis. At this point, we have gotten 25 registration of approximately 300,000 firms. And we

     NEAL R. GROSS

     COURT REPORTERS AND TRANSCRIBERS

     1323 RHODE ISLAND AVE., N.W.

    (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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