FDA User Fees

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.

GAO found that: (1) the act's reporting requirements, if fully complied with, will provide sufficient information on the timeliness of FDA performance, but FDA performance is not the sole determinant of how long it takes for a new drug to become available to the public; (2) FDA performance is measured from the official filing of a new drug application to FDA approval; (3) FDA is held accountable for only those processes over which it has control; (4) additional data are needed to evaluate whether the act has improved the public health because there is no requirement to measure how long it takes for drugs to become available to patients, compare timeliness data before and after the institution of user fees, and determine other effects of the act besides timeliness improvements, if any; and (5) drug availability can be delayed by incomplete applications, labeling disputes, and the time the sponsor takes to reply to FDA queries and actions.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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