"They've taken a clear stand, a strong stand, and they deserve some credit for that," said Alastair Wood of Vanderbilt University, the chairman of the 32-member February advisory panel on anti-inflammatory drugs. Like Furberg, he had advocated removing Bextra from the market, but the panel narrowly voted in favor of keeping it available. The FDA rejected the panel's recommendation.
"I just hope [the FDA] won't allow itself to be beaten down now that it's reasserted its public health role," Wood said. "This is a tough climate for aggressive regulation."
The Pharmaceutical Research and Manufacturers of America, which represents the brand-name drug industry, does not comment on specific FDA decisions about individual drugs. But it, too, saw a possibly significant change in FDA decision-making last week and found it worrisome. Drugmakers have been generous donors to President Bush's campaigns, and the industry's needs have been important to the administration.
"It's fair to say we're always concerned whenever a drug gets withdrawn from the market, especially if it may lead to a perceived shift in the risk-benefit evaluation," said Alan Goldhammer, the group's associate vice president for regulatory affairs. "When we meet with the FDA, it's often to highlight the fact that the patient's needs have to be respected, and patients need new therapies to treat critical medical issues."
Wood and others said that they believe the intense public attention on the Vioxx withdrawal and troubles that followed -- as well as some strong criticism from Congress of FDA actions and inaction -- played a role in the agency's tough ruling last week. Influential members of Congress, including Senate Finance Committee Chairman Charles E. Grassley (R-Iowa), are pushing for a more independent drug-safety office within the FDA, and the agency has to show that it can respond aggressively to safety concerns if it wants to succeed in fighting off long-term structural changes.
Some lawmakers say that the problem is greater than can be fixed by recalibrating the agency's risk-benefit equation and that the FDA must be restructured.
"The FDA and the companies it is charged with regulating appear to have a very close relationship that may be impeding the ability of the agency to credibly evaluate and regulate serious drug problems," said Rep. Rosa L. DeLauro (D-Conn.). "Congress must consider reorganizing FDA to assure that the individuals being served are the patients of the United States."
Others see the drug industry using its current troubles to make better and safer products. Since the Vioxx withdrawal, the private Bethesda company United BioSource Corp. has seen a doubling in its business of studying how drugs on the market are being used and what unexpected problems might be arising.
Chief Executive Ethan Leder said many drug firms "want to be able to demonstrate their products are safe in the real world, and to understand better what possible risks patients might have so that information can be shared. . . . These post-market studies were not always where companies wanted to invest resources before, but they really want to know the answers now."
