Prescription Drugs: Many Factors Affected FDA's Approval of Selected 'Pipeline' Drugs: HEHS-00-140

August 2000
GAO Reports;8/10/2000, p1
Government Document
The Drug Price Competition and Patent Term Restoration Act of 1984 seeks to expand the availability of more effective and affordable drugs by providing the generic drug industry with a simplified and faster review process and brand-name drug companies with an extension of the existing 17-year patent protection. At the time of the law's enactment, drugs for which a patent had been issued and human trials begun were considered "pipeline" drugs and were limited to two-year patent extensions. Legislation (H. R. 1598 and S.1172) has been introduced to allow manufacturers of pipeline drugs to apply for a patent extension beyond that two-year limit. This report compares FDA review and approval times of pipeline drugs with other drugs and examines whether the two-year patent extension granted to pipeline drugs under current law is based on the average length of time for FDA approval of new drug applications. GAO found that approval times for the pipeline drugs on which the study focused were significantly longer than the corresponding average approval times, ranging from 17 to 65 months longer than the average time for comparable pipeline drugs. In general, delays in FDA approval resulted from concerns about safety and efficacy, chemical properties, and manufacturing procedures. Specific concerns varied by drug. Concerning the basis for the patent-extension limit, the legislative history of the 1984 Act does not clarify why a two-year limit for patent extension was chosen for pipeline drugs or why a five-year limit was chosen for other drugs.


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