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Speeding Up the Drug Review Process: Results Encouraging but Progress Slow

HRD-82-16 Published: Nov 23, 1981. Publicly Released: Dec 23, 1981.
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Highlights

GAO reviewed the Food and Drug Administration's (FDA) drug review process to determine the status and effectiveness of FDA efforts to reduce the processing time of new drug applications. The review concentrated on: (1) recent new drug application approval data to determine whether FDA was making progress in speeding up the process; (2) implementation of a number of recent FDA initiatives aimed at speeding up the drug review process; and (3) other suggestions that have been made to speed up the drug review process and the extent to which they might be implemented by FDA. GAO compared the time required to approve new drug applications received by FDA during fiscal years (FY) 1976 and 1977 with the time required to approve those received in FY 1979 and 1980.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to revise the system used in measuring FDA progress to provide for the types of comparisons identified in this report.
Closed – Not Implemented
FDA will continue to use the same system in effect today to monitor its progress in achieving its goals. According to FDA, a database for making comparisons with past performance has been developed and such information is reported to the Office of the Secretary on a quarterly basis.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop an accurate computerized database on which such a system would draw by correcting the errors in the existing computerized database.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to notify all applicants individually when they have an important new drug that is a candidate for pre-new-drug application submission of manufacturing and controls data, but emphasize that they should presubmit these data only if they are complete and in final form.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to communicate in writing to all new drug application reviewers the FDA priority review requirements. Such requirements should emphasize the need to: (1) begin the review of important drugs ahead of others; (2) notify new drug application sponsors immediately after the chemist, pharmacologist, and medical officer have completed their respective reviews; and (3) request work from FDA support groups, such as validating laboratories, early in the review process.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to decide what FDA will require for methods validation, communicate these requirements to new drug application sponsors and all FDA review and laboratory chemists, and establish controls to see that these requirements are followed.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to expedite the FDA review of the draft biopharmaceutical guidelines and make them available to new drug application sponsors as soon as this review is completed.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish a guideline for requesting biopharmaceutical studies and see that biopharmaceutical requests are made in a timely fashion.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to make statistical guidelines available to all new drug application sponsors as soon as they are completed.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to make sure that medical officers involve the Division of Biometrics statisticians early in the new drug application review process.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to prepare a report to the Chairman, Subcommittee on Natural Resources, Agriculture Research and Environment, House Committee on Science and Technology, detailing each change it has made or plans to make to speed up the drug approval process and estimating the amount of review time the change has saved or is expected to save.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to publish annually quantitative data showing approval rates for each type of drug, such as new molecular entities, new salts, and new formulations by each reviewing division, for use by program officials and Congress.
Closed – Not Implemented
FDA annually publishes a new drug evaluation briefing book which reports statistics on various aspects of the new drug approval process including numbers and approval times. FDA does not believe that reports on the small number of applications reviewed by individual divisions and comparisons among divisions would be either appropriate or meaningful.

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Topics

Consumer protectionDrugsFood and drug lawPharmaceutical industryPharmacological researchProgram evaluationProgram managementDrug approvalsGeneric drugsBiometrics