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Friday, May 11, 2007

Senate FDA Reform Bill: Amendment Frenzy

In the Senate's FDA Reform/PDUFA Reauthorization bill, the nuts and bolts of the legislation would levy the most impact on FDA's operations and funding. However, much of the legislative intrigue occurred on the floor as Senators attempted to attach valuable amendments.

Much of the media attention on the bill went to a drug importation amendment which passed but in a fairly useless form. Reg•Watch reported on this Tuesday.

Shortly before the vote on the final bill, three amendments were brought to the floor. Sen. Chuck Grassley (R-IA) introduced an amendment which would have involved the Office of Surveillance and Epidemiology in post-market safety reviews, instead of leaving all the responsibility to the highly politicized Office of New Drugs. The amendment was rejected 47-46.

Majority Whip Dick Durbin (IL) introduced an amendment which would have made it more difficult for scientists with financial conflicts of interest to serve on FDA advisory panels. In a heartbreaker (a 47-47 vote), the amendment was rejected.

Grassley introduced another amendment which would strengthen FDA's ability to fine pharmaceutical companies who fail to conduct adequate post-market safety reviews. That amendment was easily agreed to, 64-30.

The New York Times ran a story today lauding the bill's two lead sponsors, Sens. Ted Kennedy (D-MA) and Mike Enzi (R-WY), for their bipartisan cooperation in moving the bill through the Senate.

However, the two Senators are largely responsible for the defeat of amendments which would have made Americans safer and, on the drug importation amendment, saved Americans money. Prior to the vote on the final three amendments, Kennedy made blustery speeches urging Senators to vote "nay."

Kennedy may have been holding together a bipartisan compromise, but there was no harm in attaching these amendments to must-pass legislation. Kennedy's words may have been a deciding factor in such close votes. (On the drug importation amendment, the absence of a handful of Senators — mostly Democrats — gallivanting across the country running for an election 18 months in advance didn't help either.)

The provisions in the bill increasing the power of FDA are good, but they could have been better. Oh well, there's always the House.