US FTC sides with generics makers over drug samples

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US FTC sides with generics makers over drug samples

INICIO/Políticas y legislación | Posted 05/04/2013 0 Post your comment

The US Federal Trade Commission (FTC) has come out in support of generics companies trying to get hold of brand-name drugs in order to make generic versions.

Generics companies Actavis, Apotex and Roxane have asked a US district court to force Actelion to sell samples of two brand-name drugs to the generics drugmakers. They argue that Actelion is engaging in unlawful anti-trust behaviour by refusing to sell the products. The three generics companies filed counterclaims against Actelion in the US District Court for New Jersey in response to a pre-emptive lawsuit filed by Actelion against Apotex and Roxane in September 2012. Actavis intervened later, joining Apotex and Roxane.

Now the FTC has filed an amicus brief with the court explaining that brand-name drug manufacturers may ‘improperly use restricted drug distribution program[me]s to impede generic[s] competition’.

FDA has placed restrictions on certain drugs that are either dangerous or prone to abuse; however, it appears that originator companies are exploiting these FDA restrictions as a way to prevent generics competition. Generics manufacturers need samples of the brand-name drug in order to carry out comparative clinical trials with their generic drug to prove bioequivalence, but getting hold of some drugs is proving very difficult.

The FTC says that if Actelion’s legal position were to be adopted by the court, this could ‘pose a significant threat to competition in the pharmaceutical industry’.

The Generic Pharmaceutical Association (GPhA) applauded the FTC’s stance, saying that GPhA ‘strongly supports the FTC’s opposition of this anti-consumer practice’. Mr Ralph G Neas, President and CEO of GPhA added that ‘at a time of great budgetary challenges for consumers and for the federal government, it is especially important that barriers to fair and timely generic drug and biosimilar competition are addressed, and the FTC’s forceful arguments make a compelling case.’ The GPhA has also filed an amicus brief in the case.

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Source: FTC, GPhA