Food and Drug Administration

Public Meeting — Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

Transcript from Meeting

When: October 27, 1997
Time: 9:00 a.m. to 6:00 p.m.
Where: Cohen Building Auditorium, 330 C Street, S.W., Washington, D.C.

On August 15, 1997, the Food and Drug Administration (FDA) published a proposed rule for new regulations requiring pediatric studies of certain new drug and biological products. As a part of this rulemaking, FDA, in cooperation with the American Academy of Pediatrics (AAP), is holding a public meeting on October 27, 1997, to discuss issues surrounding this proposed regulation. The meeting will include several panels in the morning that will discuss specific questions and subject areas relating to the regulations. These panels will be made up of recognized experts in the field, including members of the pharmaceutical industry and representatives from patient/consumer groups. In the afternoon, FDA will open the floor to any interested party who may wish present comments which will be included in the record and considered during FDA's rulemaking process.

Each panel will last one hour. Each panelist will have 3-5 minutes to make an opening statement, and then there will be a discussion between the panelists and a joint FDA/AAP Committee during the remaining part of the hour. Following is a list of the panel discussions.

Panel 1: When are Studies Needed?

• definition of "widespread use"
• severity of illness
• study requirements for NMEs vs. drugs already on the market

Panel 2: Comments on Testing

• extrapolating from adult, pharmacokinetic, and safety data
• defining dose ranging
• what age ranges should be tested?
• should neonates be included or excluded?
• how patients need to be enrolled?

Panel 3: Special Challenges to Testing Children

• what conditions warrant waivers and deferrals?
• should formulation constitute waiver?
• discussion of cost issue/industry burden
• ethical issues surrounding the testing of children (i.e. informed consent)

For further information contact:

Khyati N. Roberts
Center for Drug Evaluation and Research (HFD-6)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-594-6779 (phone)
301-594-5493 (fax)
robertsk@cder.fda.gov (email)

or

Elaine C. Esber
Center for Biologics Evaluation and Research (HFM-30)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-827-0641 (phone)
301-827-0644 (fax)
esber@1.cber.fda.gov (email)

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