3/13/2013 7:31:02 AM
Should a brand-name drugmaker be required to sell samples of its medicine to an aspiring generic rival when its medicine was approved with a Risk Evaluation and Mitigation Strategy? What if the brand-name drugmaker argues that its REMS could be threatened by relinquishing strict control of its medicine? And what about the notion that a company should not be forced to do business with another company if it chooses not to do so? The issue has grown increasingly contentious and, last summer, language designed to sort out those questions nearly found its way into the Food and Drug Administration Safety and Innovation Act. Generic drugmakers and their allies, including some insurers and pharmacy benefit managers, complain that brand-name drugmakers use the strict distribution provisions of the REMS regulation as an excuse not to provide samples needed for bioequivalence testing. Now, though, the US Federal Trade Commission has sided with generic drugmakers. The agency has just filed a brief in one such case to argue that brand-name drugmakers that withhold samples from generic drugmakers are stifling competition. The case involves Actelion Pharmaceuticals, which is trying to prevent Apotex and Roxane Laboratories from selling generic versions of its Tracleer drug for treating pulmonary arterial hypertension. In a lawsuit filed last September, Actelion notes its drug is distributed only through pharmacies, physicians and healthcare settings that are “speically certified and bound by contract to follow a strict protocol to monitor and protect patient health… Any harm caused by the potential misuse of Tracleer during testing by a generic could have a significant impact on Actelion and Tracleer’s reputation and standing in the marketplace.” Actelion charges that both Apotex and Roxane sent threatening letters asserting the brand-name drugmaker was obligated to provides samples, and goes on to argue that there is no requirement for providing samples to generic drugmakers and, in fact, is prevented from doing so under REMS stipulations. Actelion also notes that Congress twice failed to pass legislation that contained such requirements but ultimately failed to do so.
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