Summary: 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.
