1997.08.13: FDA PROPOSES TO REQUIRE PEDIATRIC DATA PRIOR TO DRUG AND BIOLOGIC PRODUCT APPROVALS

This is an archive page. The links are no longer being updated.

Date: Wednesday, August 13, 1997
FOR IMMEDIATE RELEASE
Contact: Ivy Kupec (301) 443-3285

FDA PROPOSES TO REQUIRE PEDIATRIC DATA PRIOR TO DRUG AND BIOLOGIC PRODUCT APPROVALS

FDA has proposed a rule to make more medical treatments available to children. Published in today's Federal Register, the proposed rule would require pediatric-use data for medicines which may offer improved treatment for children over existing therapies.

Today's proposal would require companies to submit data that could then be put on a drug's label to help pediatricians and other health care providers make treatment decisions based on scientific information about their patient population.

"Kids deserve the same access to newly developed drugs that their parents get," said Donna E. Shalala, secretary of Health and Human Services. "With this proposal, we will have the power to ensure pediatricians and other health care providers who treat children have the best scientific information available on which to base their medical decisions."

Even for drugs that are already marketed, this regulation would codify FDA's authority to require, in compelling circumstances, that manufacturers conduct studies to support pediatric-use labeling for the approved indications.

In 1994, the Food and Drug Administration issued a regulation to encourage drug manufacturers to submit pediatric data voluntarily for review. However, many new drugs are still being approved without information on how they should be used in children.

Without adequate information, physicians may be reluctant to prescribe certain drugs for their pediatric patients, or they may prescribe them inappropriately.

"When drug labels do not include pediatric information, health care providers are forced to play a guessing game and may not properly dose their patients," said Michael A. Friedman, M.D., FDA lead deputy commissioner. "Not only does this mean sick kids sometimes don't get better, but they also have the potential to get worse as a result of unexpected adverse events."

The proposed rule would allow post-approval submission of pediatric data if FDA had safety concerns about testing the drug on children prior to approval.

Likewise, the requirement could be waived if:

FDA found that the product was likely to be unsafe or ineffective in pediatric patients

that pediatric studies were impossible or highly impractical

that reasonable efforts to develop a pediatric formulation had failed.

FDA invites written comments on the proposal from the public and industry, which may be submitted to the Dockets Management Branch, HFA-305, Food and Drug Administration, 12410 Parklawn Drive, Room 1-23, Rockville, MD 20857. The closing date for comments is DATE, 1997. All comments received will be reviewed and considered by the agency in developing the final rule.

###

Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.