Generic Companies Gain Little From FDA Decision On Access To REMS Drugs

13 Aug 2013

• By Cathy Dombrowski

The agency says the FDAAA does not allow a REMS to state that a brand sponsor cannot use a limited distribution program to prevent generic drug maker’s access to a product for bioequivalence testing.

In response to a petition from Dr. Reddy's Laboratories Ltd., FDA indicated that a policy to force brand companies to sell products governed by a Risk Evaluation and Mitigation Strategy to generic firms for bioequivalence testing is not forthcoming from the agency.

Section 505-1(f)(8) of the Food, Drug and Cosmetics Act says that an element to assure safe use (ETASU) cannot be...