Food and Drug
Administration
Center for Drug Evaluation and Research
Advisory
Committee Conference Room, Rm. 1066,
Mary Glode, M.D.
AntiViral Drugs Advisory Committee Members Present
Lauren Wood, M.D. Jan Englund, M.D. Courtney Fletcher, M.D.
Patricia Chesney, M.D. Robert Fink, M.D. Mark Hudak, M.D.
Robert
Nelson, M.D., Ph.D. David
Danford, M.D. Victor
Santana, M.D.
Richard Gorman, M.D., FAAP Keith Rodvold, Pharm.D. Ellen Chadwick, M.D.
Norman
Fost, M.D. John Sever, M.D.
Lynne
Mofenson, M.D. Benjamin
Wilfond M.D. Steven
Spielberg, M.D.(Industry Rep.)
FDA
Participants
Dianne
Murphy, M.D. Linda
Lewis, M.D. Shirley
Murphy, M.D.
Melissa
Baylor, M.D. Solomon
Iyasu, M.D.
These summary minutes for the March 3, 2003 meeting
of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee
were approved on March 14, 2003.
I
certify that I attended the March 3, 2003 meeting of the Pediatric Subcommittee
of the Anti-Infective Drugs Advisory Committee,
and that these minutes accurately reflect what transpired.
_______________________________ _______________________________
Thomas H. Perez, M.P.H., R.Ph. Patricia
Chesney, M.D.
Executive Secretary Chair
The Pediatric
Subcommittee of the AntiInfective Drugs Advisory Committee, of the Food and Drug Administration, Center for
Drug Evaluation and Research met March 3, 2003 at the Advisory Committee
Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD.
The Committee discussed the
development of antiretroviral drugs in HIV-infected and HIV-exposed neonates
younger than four weeks of age.
Following this at 2:40 p.m., the agency provided an update to the
subcommittee on the Adverse Event Reporting plan as mandated in Section 17 of
the Best Pharmaceuticals for Children Act.
After this presentation, at approximately 4:00 p.m., the agency provided
an update on pediatric initiatives within the agency.
The Committee and invited guests received a briefing
document from the FDA in preparation for this meeting.
There were approximately 70 persons present. The meeting was called to order at 8:20 a.m.
by the Chair, Joan Chesney, M.D. The Committee members and discussants
introduced themselves. Thomas H. Perez,
Executive Secretary of the Pediatric Subcommittee of the AntiInfective Drugs
Advisory Committee read the Meeting Statement.
A welcome and opening comments were provided by Dianne Murphy, M.D., Director, Office of Pediatric Therapeutics.
Presentations began at 8:30 a.m. and proceeded as
follows.
State of the Art: Perinatal Transmission Lynne Mofenson, M.D., National Institute of Child Health
and Human Development
Ethics of Neonatal Research John Sever, M.D., Children’s Hospital National Med. Ctr.
FDA Perspective Linda Lewis, M.D., Division of Antiviral Drug Products
After a 15 minute break the
meeting was reconvened at 10:40 with the Open Public Hearing. The committee heard from one participant,
James M. Oleske, MD, M.P.H., Francois‑Xavier Bagnoud Professor of
Pediatrics. An additional 4 statements
that were received from the public were read into the record by the Chair.
Linda Lewis, M.D., provided an introduction to the
questions that FDA presented to the Subcommittee for discussion. The Subcommittee discussed the questions and
broke for lunch at 12:20 p.m. The
Subommittee reconvened at 1:10 p.m. and continued the discussion of the
question. At 2:20 the Subcommittee
concluded its discussion of the questions.
After a 20 minute break the meeting resumed with the
Pediatric Update to the Subcommittee and the following presentations.
Overview: Division of Pediatric Drug Development Dianne Murphy, M.D.,
Office of Pediatric Therapeutics Director, Office of Pediatric Therapeutics
Medwatch Min Chen, M.S., Division of Drug Risk Evaluation
Adverse Event Reporting Solomon Iyasu, M.D.,
Division
of Pediatric Drug Development
Division of Pediatric Drug Development – Update Shirley Murphy, M.D.
Division of Pediatric Drug Development
New Exclusivity / Rule Statistics Terrie Crescenzi, R.Ph., Office of Counter-Terrorism
& Pediatric Drug Development
The presentations ended and the meeting was
adjourned at 4:30 p.m.
The Subcommittee discussed the following questions
to which no votes were requested or taken.
The discussion will be made available through the meeting transcripts
and placed on the web in approximately three weeks. Transcripts may be accessed at the following
web address.
www.fda.gov/ohrms/dockets/ac/acmenu.htm.
Questions to the Committee
Committee’s Vote: 0 Yes 15
No
The Committee expressed the need to develop
strategies to allow for enrichment of the population recruited, and that
studies should be done when they are needed where the risk benefit ratio is
justified.
Committee’s Vote: 0 Yes 15
No
Refer to the transcript for the committee’s
discussion of this question.
Committee’s Vote: 15 Yes 0
No
The Committee indicated that would depend on the
control of study variables found in the populations, compliance and overall
quality of the data.
The Committee consensus was yes, assuming that the
study issue is ethical, and with a public health benefit.
The committee also included the following additional criterias; formulation availability, breast feeding, tolerable toxicity, and bioavailability. Refer to the transcript for the committee’s discussion of this question.