Pay-for provisions a sticking point in PDUFA negotiations

Different mechanisms to pay for PDUFA reauthorization are emerging as a sticking point as Congress works to reconcile Senate and House versions of the PDUFA bills. The Generic Pharmaceutical Association (GPhA) and pharmaceutical benefit managers are lobbying for the inclusion of provisions from the Senate version that would reduce marketing barriers for generics and biosimilars. The provisions, estimated by the Congressional Budget Office (CBO) to save the federal government $753 million over 2013-22, would prevent branded manufacturers from using a product's REMS as justification for refusing to sell to manufacturers that want to use the branded product in the development of a generic or biosimilar.

In a Thursday conference call with AARP and pharmacy benefit manager Express Scripts Inc. (NASDAQ:ESRX), GPhA said House legislators removed the language after an "aggressive" lobbying campaign by the Pharmaceutical Research and Manufacturers of America. They said Celgene Corp. (NASDAQ:CELG) has used a REMS to deter development of generic of cancer drug Revlimid lenalidomide. Lobbyists for the Biotechnology Industry Organization said in a memo the provisions expose innovator companies to potential liability for harms done to patients during development of a generic or biosimilar. ...