Prescription Drugs: Many Factors Affected FDA's Approval of Selected 'Pipeline' Drugs

Pursuant to a congressional request, GAO provided information on the Food and Drug Administration's (FDA) review and approval of drug manufacturers' applications to market seven drugs that would be covered by H.R. 1598 and S.1172, focusing on: (1) the review and approval times for the seven pipeline drugs in comparison with other drugs and the factors that contributed to the time FDA required to approve the three of the seven drugs for which the manufacturers agreed to supply GAO with information; and (2) whether Congress based the 2-year patent extension granted to pipeline drugs on the assumption that FDA action on these drugs' applications would occur within the average length of time for FDA approval of new drug applications.