Prescription Drugs Many Factors Affected Fda's Approval of Selected "Pipeline" Drugs

Summary: Legislation was recently introduced to institute a process by which the manufacturers of pipeline drugs (PD) that took longer than 5 years to be approved & whose patents were still in effect could apply for a patent extension. 7 of the 122 PD would be eligible for review under this proposal. This report examines FDA review & approval (R&A) of the manufacturers' applications to market 7 drugs that would be covered by ...the proposed legislation. It examined: the R&A times for the 7 PD in comparison with other drugs & the factors that contributed to the time FDA required to approve the 3 of the 7 drugs for which the manufacturers agreed to supply information. [read more]