United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Program Evaluation and Methodology Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1994-07-22 monographic deposited born digital GA 1.13:PEMD-94-26 https://www.govinfo.gov/app/details/GAOREPORTS-PEMD-94-26 P0b002ee180376eba f:pe94026 DGPO 2010-08-12 2011-03-28 GAOREPORTS-PEMD-94-26 machine generated eng fdlp REPORT GAOREPORTS-PEMD-94-26 PEMD-94-26 Regulatory agencies Pharmaceutical industry Food and drug legislation Product performance evaluation Drugs Reporting requirements Data collection operations Fees Letter Report PEMD 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. https://www.govinfo.gov/content/pkg/GAOREPORTS-PEMD-94-26/html/GAOREPORTS-PEMD-94-26.htm GAO/PEMD-94-26 https://www.govinfo.gov/app/details/GAOREPORTS-PEMD-94-26 Letter Report GAO/PEMD-94-26; FDA User Fees: Current Measures Not Sufficient for Evaluating Effect on Public Health; Regulatory agencies Pharmaceutical industry Food and drug legislation Product performance evaluation Drugs Reporting requirements Data collection operations Fees