Summary: Although the Food and Drug Administration (FDA) has been able to reduce its processing time by about 42 percent, problems still remain. Some reviewing divisions have increased their review time; therefore, additional management scrutiny of these divisions may provide opportunities to reduce further processing times. The new drug application (NDA) computerized data on processing time are unreliable and cannot be used to analyze FDA progress in approving drugs. FDA conducts conferences with drug firms at the end of phase II clinical testing to speed up the drug's development during phase III. Because manufacturing and controls reviews add to the time taken to approve drugs, FDA requested firms to submit the manufacturing and controls data for drugs that are classified as important before submitting the full NDA. A priority review system has been established to give important drugs special attention. FDA has established a 45-day goal for validating analytical methods proposed by drug firms, but it has recognized the need to clarify its methods for validation and has drafted guidelines for that purpose. Efforts to speed up biopharmaceutical reviews have not been totally successful because poor coordination exists between biopharmaceutics reviewers and other FDA reviewers of NDA material. Statistical reviews continue to be delayed because data requirements of the statistician have not been adequately communicated to NDA sponsors, and statistical reviews are not requested in some cases until late in the NDA review phase. Guidelines in this area are currently being revised. While proposed revisions of NDA guidelines should be published by March 1982, they will not become final for at least 2 more years. Many of the FDA changes are procedural. The extent to which they will improve communication between industry and FDA is unknown and can only be assessed over time. Because of the importance attributed to the proposed revisions of the regulations and the time which this effort has taken, GAO recommends that the Secretary of Health and Human Services direct the Commissioner of FDA to prepare a report to Congress detailing each change it has made or will make to speed up the drug approval process and estimating the amount of review time the change has saved or is expected to save. The proposed policy change in the handling of post-1962 generic drugs requires close scrutiny to assure that unexpected adverse impacts are minimized.
