Innovators have used REMS to block generic and 505(b)(2) developers from gaining access to the reference listed drugs (RLD), effectively blocking their development. The 2012 Congress failed to pass legislation to force innovators to provide access to the RLD’s. FDA believes it has no authority to assist. In fact, FDA refuses to reveal if the product sold outside the US (without REMS) is the same as the approved drug.
Apotex and Roxane both requested Actelion Pharmaceutical Ltd. to provide samples of TRACLEER (bosentan) Tablets for BE testing threatening antitrust action if Actelion did not comply. Rather than wait for the threatened action, Actelion filed a preemptive suit at the U.S. District Court for the District of New Jersey. In the suit, Actelion argues that it can sell its product to whomever it wants. Both Apotex and Roxane have filed counterclaims (Apotex; Roxane) invoking the Sherman Act on antitrust claims.
We are hoping that the FTC also intervenes. Maybe the Courts can do what Congress failed to do.