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White House budget proposal could impact drug exclusivity
March 2011
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WASHINGTON, D.C.—The U.S. government's recently unveiled 2012 budget plan includes several proposals that will significantly affect both brand-name and generic drug manufacturers. The budget includes two proposals "to increase availability of generic drugs by providing the Federal Trade Commission (FTC) authority to stop drug companies from entering into anticompetitive agreements intended to block consumer access to safe and effective generics, and hastening availability of generic biologics while retaining the appropriate incentives for research and development for the innovation of breakthrough products." Specifically, the first proposal calls for an end to "pay-for-delay" deals on traditional drugs by giving the FTC the authority to block them, a move that reportedly could save $8.8 billion by 2021. The proposal also calls for the existing 12-year market exclusivity period for new biologic drugs to be reduced to seven years, which the Obama Administration estimates could save a combined $2.3 billion between 2012 and 2021. Each of the proposals is contingent upon the enactment of authorizing legislation.


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