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Wednesday, May 09, 2007

PDUFA Reauthorization Passes in Senate

Moments ago, the Senate voted 93-1 to pass S. 1082, The Food and Drug Administration Revitalization Act. The two primary aims of the legislation are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the FDA.

The House will take up similar legislation in the coming weeks. President Bush has threatened to veto the legislation if it includes a provision allowing the importation of cheap drugs. As Reg•Watch reported yesterday, the Senate bill does include such a provision, but it was rendered useless by another amendment which requires an approval process too onerous for FDA to ever handle. Subsequently, the White House is now saying Bush is unlikely to veto the bill if it were to cross his desk in its current form, according to BNA news service (subscription). Stay tuned to Reg•Watch for more on the bill.