FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining that a brand name drug manufacturer’s improper use of a restricted drug distribution program to impede generic competition could violate the antitrust laws.

The FTC filed the brief in the matter of Mylan Pharms Inc versus. Celgene Corp (Case No 2:14-cv-2094), which involves allegations that biotech firm Celgene (Nasdaq: CELG) has prevented generic drugmaker Mylan (Nasdaq: MYL) from offering competing generic versions of Celgene’s brand drug products, Thalomid (thalidomide) and Revlimid (lenalidomide), by precluding the firm from obtaining samples of those drugs to perform necessary testing. Both drugs are used to treat several forms of cancer, as well as other serious conditions.

To receive approval from the Food and Drug Administration, generic firms are required to conduct bioequivalence testing to demonstrate that a generic formulation is therapeutically equivalent to the brand drug. This testing requires access to a limited amount of the brand product. Certain brand drugs are subject to distribution restrictions that can be used to prevent generic firms from obtaining samples of the brand product for testing purposes.