Burgess Seeks GAO Study On Approval Challenges Presented By Generic Complex Drugs

Rep. Michael Burgess (R-TX) introduced a bill last week that calls for the Government Accountability Office to observe whether generic versions of nonbiologic complex drugs and biological products that fall under the temporary approval authority of the Food, Drug and Cosmetic Act, present significantly different challenges in meeting approval standards than challenges presented by generic drugs of small-molecule reference products. If this is determined, the bill suggests that GAO ponder amending the generic drug pathway to address the approval of...