FTC files Amicus Brief, saying improper use of restricted drug distribution programs may impede generic competition

The US Federal Trade Commission has filed an amicus brief in the US District Court for the District of New Jersey explaining that brand name drug manufacturers may improperly use restricted drug distribution programs to impede generic competition. The Commission vote approving the filing of the amicus brief was four to zero.

The FTC filed the brief in the matter of Case No 1:12-cv-05743, which involves allegations that Switzerland-based biotech firm Actelion (SIX: ATLN) has prevented generic drugmakers Actavis, Apotex and Roxane from offering competing generic versions of Actelion’s brand drug products, Tracleer (bosentan) for arterial pulmonary hypertension and Zavesca (miglustat) for type 1 Gaucher disease, by precluding them from obtaining samples of those drug to perform necessary testing.

In order 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.