REMS program becomes a competitive ploy in branded-generic patent disputes

Ever since the Hatch-Waxman Act was passed in 1984, spawning what is today the multibillion-dollar/yr generics industry, both generics firms and innovator firms have tested every conceivable defense or mode of attack to either protect existing innovator drugs, or to open them up to generic competition. Now, apparently, the FDA Risk Evaluation and Mitigation Strategies (REMS) program has become a card in this game.

On March 11, FTC filed an amicus curiae brief in the case of Actelion Pharms Ltd. Vs Apotex Inc. (Case No. 1:12-cv-05743), currently being heard in the US District Court for New Jersey. In that suit, Apotex, Actavis and Roxane allege that they have been prevented from obtaining samples of Actelion’s drugs, Tracleer (bosentan) and Zavesca (miglustat), for the purposes of running bioequivalence studies, as preparation to making an Abbreviated New Drug Application (ANDA) to FDA to produce generic versions.

For its part, Actelion claims that it is under a REMS program that restricts access to the drug and (according to FTC) “contends that its distribution restrictions are required by the FDA, [and] argues that its right to refuse to sell to the generic firms is nearly absolute and would apply even without any FDA mandate." FTC notes in its brief that Actelion asserts that “the legislative history of [the FDA Amendments Act of 2007, which originated the REMS program] supports its position.” That is, even though there is explicit language in FDA REMS regulations that prohibit using REMS as a brand-protection barrier, because Congress did not explicitly make that part of the law, it can be ignored.

REMS programs came into being as a means of allowing certain drugs with known risks to be approved by FDA, provided that the use of those drugs was closely monitored in patients. The Actelion drugs have an ETASU (Elements to Assure Safe Use) provision in their REMS programs that restricts both distributors and pharmacies handling the drugs.

The overall case turns on many intricacies of antitrust law and precedent, in addition to the details of REMS programs. GPhA, which also filed an amicus curiae brief, is happy for FTC’s position: “GPhA strongly supports the FTC’s opposition of this anti-consumer practice,” said Ralph G. Neas, president, in a statement. There’s no word on when the District Court decision might be handed down.