FDA User Fees:

Current Measures Not Sufficient for Evaluating Effect on Public Health

PEMD-94-26: Published: Jul 22, 1994. Publicly Released: Aug 22, 1994.

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Pursuant to a congressional request, GAO reviewed the legislative requirement that the Food and Drug Administration (FDA) annually report certain data to Congress, focusing on whether the data are sufficient to evaluate how well the Prescription Drug User Fee Act of 1992 has achieved its goal of getting drugs to patients sooner.

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.

Matters for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require HHS to report the number of and severity of postapproval problems and the rate of withdrawal of unsafe or ineffective drugs from the market.

  2. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require HHS to report the number of major and minor amendments, the number of new drug application supplements for new or expanded indications, and the number of postmarketing requirements per new drug application.

  3. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require HHS to report the number of priority and standard drugs submitted and approved.

  4. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require HHS to report the number of new drug applications submitted per year and the numbers of these that were refused to file, withdrawn, found not approvable, resubmitted, or approved.

  5. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require HHS to report on FDA action time, new drug application approval time, and time to market for all new drug applications. FDA should measure time to market as follows: (1) establish the date when the sponsor first submitted a new drug application--the submission date, regardless of whether the new drug application was deemed complete or filed by FDA; (2) establish the date when final printed labeling was approved and the sponsor had permission to market the drug--the permission date, regardless of when the approval letter was issued; and (3) subtract the submission date from the permission date to obtain the time to market.

  6. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require the Department of Health and Human Services (HHS) to report on the length of the investigational new drug phase for all new drug applications.

  7. Status: Closed - Not Implemented

    Comments: The Prescription Drug User Fee Act of 1992 was reauthorized in the Food and Drug Modernization Act of 1997 (Public Law 105-115). Congress did not institute this reporting requirement for FDA.

    Matter: Congress should require HHS to provide the recommended data for all new drug applications submitted to FDA during the years prior to 1993 and all new drug applications submitted during 1993 and onward. The "before" data could be reported beginning at some point after the last major revision of the new drug application regulations in 1985.

 

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