Some of the criticism comes from unexpected places. Sen. Charles E. Grassley (R-Iowa) has taken a lead role and will chair a Senate hearing today regarding the agency's track record on drug safety.
The hearing will focus on how Vioxx stayed on the market despite early warnings that it might increase the risk of heart attack and stroke -- allegations of foot-dragging that Merck and the agency say are unfounded. But in a larger sense, the FDA's entire drug review and post-market surveillance programs will also be on trial.
"The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny," Grassley said. "One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be the FDA's first and only concern."
Among Grassley's proposals is that the agency's relatively small Office of Drug Safety be beefed up and made more independent of the Office of New Drugs, the division that reviews and approves drug applications. (This year, the safety office received less than $24 million of CDER's budget of almost $500 million.) Grassley and other critics contend the safety office is reluctant to admit that drugs may have been approved in error. An independent safety office, he said, would not feel as constrained.
Curt Furberg, a drug safety expert at Vanderbilt University and a member of the FDA's advisory panel on drug safety and risk management, also said the Office of Drug Safety should be more independent. Furberg, who was uninvited from an important upcoming FDA drug advisory panel after he publicly questioned the safety of other drugs in the same family as Vioxx, argued that the FDA needs basic structural changes.
"I think what we've seen in the United States is that the FDA and industry have gotten very successful at getting drugs to the market based on their efficacy," he said in an interview. "But that has come at a cost: We are discovering the safety problems here after the drug has been on the market and widely used. . . . This is why I say safety has become a stepchild to the agency and the process."
While acknowledging there have been weaknesses in the FDA's safety oversight, Galson said there is no reason for an independent safety office -- in part because that would deprive safety monitors who evaluate a drug's risks of the best information about their benefits. He also defended the drop in enforcement letters about misleading advertising, saying the agency is relying more on providing companies better guidance before they start marketing.
Galson said that he sees no meaning in the decrease in the number of drugs taken off the market, but that the increase in adverse-event reports "was of some concern."
The perception that the FDA has tilted from its public health mandate toward a focus on industry needs has been reinforced for some in Congress by court cases in which the agency intervened on the side of drug and medical device makers sued by patients claiming they were harmed.
Invoking the legal theory of "federal preemption," the government has argued in at least five cases that such lawsuits threaten to disrupt a regulatory system established to ensure the flow of new and useful products. Rep. Maurice D. Hinchey (D-N.Y.), saying the court filings showed the FDA is being taken "in a radical new direction," persuaded the House to cut $500,000 from the general counsel's budget to show its displeasure.
