HHS NEWS

P97-27                         FOOD AND DRUG ADMINISTRATION   
FOR IMMEDIATE RELEASE          Ivy Fleischer Kupec: 301-443-3285  
August 13, 1997                  
                               Consumer Hotline:   800-532-4440
                                  
                                                             
            FDA PROPOSES TO REQUIRE PEDIATRIC DATA 
          PRIOR TO DRUG AND BIOLOGIC PRODUCT APPROVALS

     The Food and Drug Administration will require new drugs and
biologics to be labeled on how these medicines can be used safely
in children. In addition to new drugs, the rule will also apply
to many drugs already approved and being used.  Currently, most
drugs are not labeled for use in children. 
     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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