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Tuesday, May 01, 2007

"Calling All Germane Amendments!": PDUFA Negotiation in the Senate

Senate leaders on food and drug regulation continue to wrangle over provisions of the reauthorization of the Prescription Drug User Fee Act (PDUFA). A Senate Committee reported PDUFA to the Senate floor two weeks ago.

Because PDUFA expires in September, and because the funds it provides FDA are necessary for the agency to operate, the reauthorization legislation is considered a must pass. That makes it a golden opportunity for Senators to attach all sorts of additional provisions.

The most contentious thus far has been a proposal to give FDA the authority to approve generic drugs. The pharmaceutical industry opposes such a provision (surprise!), and, according to the National Journal (subscription) has the support of Senate Majority Leader Harry Reid. A provision for generic drugs would likely offer consumers more generic drug choices and lower prices. Sens. Ted Kennedy, Hillary Clinton, and Chuck Schumer are pushing for a generics provision. What is Harry Reid's deal?

Other additions include a moratorium on direct-to-consumer advertising for risky drugs, the creation of a single food safety monitoring agency (currently the duties are split among several bodies including FDA and USDA) and increased pet food safety monitoring, all according to the National Journal.