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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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.

FDA has made some progress in reducing processing time for new drug applications, particularly for important new drugs. The review showed that applications for approval of important new drugs received in FY 1979 and 1980 were processed an average of 36 percent faster than similar applications received in FY 1976 and 1977. However, progress among the six FDA reviewing divisions has not been consistent; four divisions have increased review time. FDA efforts to speed up the review of chemistry data by having firms submit this information for drugs classified as major or modest therapeutic advances before submitting the full new drug application can help expedite review, but firms rarely do this. Because FDA requirements for giving priority review to important new drug applications have not been communicated in writing, many reviewers have not understood the FDA priority and, therefore, treat some important drugs no differently from other drugs. Validation of the methods used by the sponsor to ensure the quality, strength, purity, and identity of a drug continues to take much longer than the FDA 45-day goal despite FDA efforts to speed up the process. Additional efforts are needed to speed up the work of the Biometrics Division and the Biopharmaceutics Division. These divisions' data requirements are not being adequately communicated to new drug application sponsors. Finally, reviewers in some FDA divisions wait until they are well into their review before identifying the material to be reviewed by these divisions.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  9. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  10. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  11. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

 

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