Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - August 13, 1997
Ivy Fleischer Kupec: (301) 443-3285
The proposed rule offers the potential that children will now receive improved treatment because doctors will have more complete information on how these powerful drugs affect children.
"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."
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 which simplified the required pediatric data in order to encourage drug manufacturers to submit this 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 adequate pediatric information, health care providers are forced to play a guessing game that may compromise the care of 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 comment period will last for 90 days, after which comments will be reviewed and considered by the agency in developing the final rule.
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SOURCE: Food and Drug Administration (FDA).
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