FDA's new drug-safety board is an imperfect solution, critics say.

By creating a new Drug Safety Oversight Board, the FDA has set out to make safety information more accessible to consumers, the agency says. But the practical effect of the new board remains to be seen. Some critics say that, although the board is a step in the right direction, it does not go far enough.

The FDA announced in February that it would establish the new board to make the agency's review and decision-making processes more independent and transparent. The board will monitor the safety of drugs on the market and provide emerging information on drugs' risks and benefits to health care providers and the public, but it will lack the authority to force withdrawal of a drug.

Is the new board a legitimate step toward enhancing drug safety, or is it merely an attempt to appear proactive?

"The FDA is a very political body," said Karen Barth Menzies, a Los Angeles attorney who represents plaintiffs in pharmaceutical cases. "The public has become aware that the FDA has some very serious problems, and publicizing the naming of a new board is a way to try to fix its damaged reputation."

The agency has faced criticism from consumer advocates, Congress, and some of its own scientists for its reluctance to withdraw drugs it has approved and for withholding information about possible risks until safety questions are fully resolved. The new board occupies a middle ground between withdrawing a potentially dangerous drug and keeping risk information secret until all data has been reviewed.

The agency has also proposed a "Drug Watch" Web site to provide consumer-friendly information on potential drug safety problems--even before the FDA has reached conclusions that would prompt a regulatory action.

The board does not change the FDA's structure. "It does not eliminate the conflict of interest inherent in the FDA with respect to postmarketing, because lines of authority remain unchanged," said Richard Kapit, a former FDA medical safety officer. "The drug safety [board] still has no direct regulatory authority--only an advisory capacity."

The fact that the agency has acknowledged a need for change is promising, said Leonard Glantz, a professor at Boston University's School of Public Health. "If there's something useful about this new plan, it's the realization that the people who do the premarketing approval shouldn't also make decisions based on the postmarketing information," he said.

But if the board includes the same people who have been criticized for their close connections to pharmaceutical companies, it is independent in name only, Menzies said.

"When private companies have problems, they change the structure of people at the top," she said. But without larger structural change, "FDA is instead reaffirming the structure that was part of the cause of the problems."

Critics have faulted the agency for placing the interests of the drug industry above those of consumers. "The mere fact that they were willing to not release safety information because it was called a trade secret by industry is stunning," Glantz said. He likened the situation to the Consumer Product Safety Commission saying the fact that the brakes on a particular car don't work is a trade secret that may not be shared with the public.

The new board will include FDA staff and medical experts from other government agencies. Kapit cautioned that pharmaceutical interests will try to influence who is appointed to the board. "The industry knows pretty much who's on their side," he said.

The board may lend more legitimacy to the use of postmarket data in litigation, Menzies said. "Spontaneous, aftermarket adverse-event reports are supposed to be used as a signal to determine when a warning would be necessary," she explained. "If we can show when that signal first occurred and the drug companies should have started to raise concerns, that will help us show whether they failed to warn soon enough about a known or potential side effect."

For example, Menzies said, in a recent case involving the antidepressant Zoloft, the judge limited the evidence to data from controlled clinical trials, excluding all postmarket adverse-event reports. But that information shouldn't be discounted, she said: "When spontaneons reports yield numerous instances of the same side effect, that's valuable information."

Glantz added that the risks of some drugs "are infrequent enough that they don't appear until you see them in larger populations."

Houston attorney Andy Vickery agreed that the board's work may help plaintiffs in some pharmaceutical cases. "It will be harder for drug companies to argue Daubert when the board has found a strong association or causal link," he said.

"In the short run, any safety information the new board releases will strengthen existing cases. In the long run, however, legally adequate warnings will insulate the drug makers from liability," Vickery said.

Glantz predicts there will be increasing tension between the FDA and industry. "Industry will continue to withhold information and work hard to block it," he said.

"No one can dispute that we are overmedicating our society, especially kids," Menzies said. By providing more information about potential risks, even if it does not conclusively prove a link between a drug and an adverse side effect, "what you're doing is increasing education and accuracy for a physician when he or she is weighing the benefits and risks."