As drugs like Vioxx and Bextra are pulled from the market, the FDA has come under increasing fire for its ties to the industry and for turning a blind eye to unfavorable data. As it turns out, Propulsid, another lucrative drug with a questionable safety record, was given a VIP-worthy escort through the FDA's safety review process.
So what's being done to eliminate this industry-government coziness? On Wednesday, the House approved a bill sponsored by Maurice Hinchey (D-NY) that would regulate financial conflicts of interest in the FDA. The bill has gone to the Senate, where it will be reviewed by the Senate Committee on Health, Education, Labor, and Pensions.
Senators Chuck Grassley (R-IA) and Christopher Dodd (D-CT) have also submitted to the committee a pair of bills together (the Fair Act to Clinical Trials Act 2005 and the FDA Safety Act) that would reform the FDA and increase transparency. In an effort to eliminate conflicts of interest, the FDA Safety Act would restructure the organization so that the safety division would no longer be a part of its drug approval division.
Committee Chairman Mike Enzi (R-WY), however, has been busy crafting his own legislation with Edward Kennedy (D-MA). The problem is, Enzi has said it's unlikely his bill will call for an independent drug safety board.
Yet this is a critical problem facing the FDA. In May, the FDA proudly announced the creation of the Drug Safety Oversight Board (DSB) to “provide oversight and advice to the Director of FDA's Center for Drug Evaluation and Research (CDER) on the management of drug safety issues.” Unfortunately, the DSB is so mired in conflicts of interest that FDA Safety Officer David Graham said “drug safety in the U.S. is worse off today than it was in November ” (see the Washington Post article).
When 11 of the 15 seats on the DSB are filled by senior managers of the CDER, the board responsible for reviewing the drugs in the first place, we're not off to a good start.
According to FDA Week, Enzi is reluctant to create an independent drug safety board because it “would make it difficult for FDA to properly balance a drug's risks and benefits.” An Enzi aide also confirmed that the senator was concerned a separate board would place too much emphasis on a drug's risks. Isn't that the idea?