FDA User Fees: Current Measures Not Sufficient for Evaluating Effect on
Public Health (Letter Report, 07/22/94, GAO/PEMD-94-26).

Congress passed legislation in 1992 requiring the Food and Drug
Administration (FDA) to charge fees for reviewing new drug applications
to determine whether the drugs can be marketed in the United States.
The fees collected are to be used to augment FDA resources devoted to
reviewing new drug applications.  This increase in resources, in turn,
is intended to speed drug review and approval. GAO reviewed whether the
data mandated by the law will be sufficient to evaluate how well the law
has achieved its goal of getting drugs to patients sooner.  GAO found
that the existing reporting requirements of the user fee act, if
satisfied, will provide detailed information on one aspect of the drug
review and approval process--the timeliness of FDA performance.
However, because FDA performance is not the sole determinant of how long
the process takes, these data alone will not be enough to evaluate how
long it takes for drugs to become publicly available, and more data are
needed.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  PEMD-94-26
     TITLE:  FDA User Fees: Current Measures Not Sufficient for 
             Evaluating Effect on Public Health
      DATE:  07/22/94
   SUBJECT:  Regulatory agencies
             Pharmaceutical industry
             Food and drug legislation
             Product performance evaluation
             Drugs
             Reporting requirements
             Data collection operations
             Fees

             
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