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For Consumers

Pediatric Advisory Committee Meeting: HIV drug development in neonates


FDA will hold a meeting of its Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee on March 3, 2003, beginning at 8:30 a.m. at the CDER Advisory Committee Conference Room (Rm. 1066), 5630 Fishers Lane, Rockville, MD, to seek public discussion and advice on issues related to the development of antiretroviral drugs in human immunodeficiency virus (HIV)-infected and HIV-exposed neonates younger than 4 weeks of age.

While there have been other public discussions regarding HIV drug development and perinatal transmission, FDA believes that it is appropriate to re-visit some specific questions regarding pediatric drug development in this age group.

The Division of Antiviral Drug Products (DAVDP) routinely encourages sponsors to study drugs for treatment of HIV in children, requesting pharmacokinetic (PK), safety, and activity data for HIV drugs in studies that include HIV-infected children from 1 month to adolescence, as well as PK and safety data in HIV-exposed neonates (infants born to HIV-infected women). Over the last year, companies have questioned the feasibility of conducting studies of antiretrovirals in HIV-exposed neonates. They note, for example, that the current success of maternal treatment and perinatal prophylaxis has reduced the rate of perinatal transmission in the U.S. to very low levels, significantly decreasing the number of infected neonates available for study. They also cite current guidelines endorsed by the American Academy of Pediatrics, NIH and FDA stating that infants who are unlikely to directly benefit from research should not be exposed to greater than "minimal risk," and suggest that exposure of uninfected infants to antiretroviral drugs constitutes a greater than minimal risk. They also express concern for parents who are trying to assimilate information about HIV transmission in their newborn and suggest that they may be poor candidates for providing informed consent during that time.

Questions to be addressed at the upcoming Advisory Committee meeting include: (1) Is it feasible and ethical to conduct studies of antiretroviral drugs in HIV-infected or exposed neonates in the United States? (2) Should we continue to request pharmacokinetic and safety studies in HIV infected neonates for every drug under development or should we develop criteria for deciding which drugs should be studied. (3) If studies are conducted in resource poor countries, where perinatal transmission rates are still unacceptably high, can the results be extrapolated to pertain to the U.S. population?

Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Oral presentations from the public will be scheduled between approximately 9:50 a.m. and 10:50 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person (see below) as soon as possible, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

If it is not possible to send a representative to the meeting, you may also send a brief email correspondence to DAVDP at to submit comments.

The contact person for this meeting is Thomas H. Perez, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-7001, or by e-mail:

You can access the Federal Register Notice announcing this meeting at

You may call the FDA Advisory Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and enter code 12530. for up-to-date information on this meeting.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Page Last Updated: 08/01/2014
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