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

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 used “to block or delay approval” of an ANDA or 505(b)(2) application. The 2009 Dr