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Restore public faith in the FDA

Dr. Lester Crawford, acting commissioner of the Food and Drug Administration, has looked the problem of drug safety in the eye . . . and blinked. Crawford proposed two new initiatives: Create a board that would advise the agency on the risks of prescription drugs, and share more of that information with the public. Sounds good, but he didn't go far enough.

Distrust of the pharmaceutical industry isn't a passing fad but is rooted in the industry's deceit, secrecy and misguided value system that puts profit above responsibility. Unfortunately for Crawford - a highly qualified health professional who has been nominated for the FDA's top job by President Bush - the agency is part of the problem. So while he recognizes the need for reform, his remedy is not bold enough.

For example, Crawford said the new Drug Safety Oversight Board would be independent, a necessary step to regain legitimacy. Will it really be? While members of the new board will be asked to advise the FDA on drug safety issues, they still will be part of the agency's review division that approves drugs. Experience has shown how difficult it is for the same group to give its seal of approval to a drug and then admit that it made a mistake.

Crawford also said the FDA will share more information about drug complications with consumers. That is refreshing to hear, particularly after allegations from inside the agency that it is slow to act on such discoveries - most recently of the health threat from pain relievers Vioxx and Celebrex. For the information to be timely and relevant, however, the FDA will have to spend more money on research.

The cost of keeping track of private health studies that exist in massive databases has been put at tens of millions of dollars yearly. Yet Bush's budget calls for no additional money for that purpose. The intention to share more information doesn't mean much if the resources to obtain it aren't adequate.

Some knowledgeable FDA critics aren't impressed with Crawford's proposal. "It's a huge opportunity that's been lost to introduce transparency and restore confidence in the system," said Dr. Alastair Wood, a Vanderbilt University associate dean and once a candidate for FDA commissioner until the pharmaceutical industry voiced its objections.

Sen. Charles Grassley, R-Iowa, who has been studying the drug-approval process, may not be easily appeased, either. He said he would go forward with legislation that establishes real independence for an office of drug-safety oversight.

If Crawford really wants to restore public trust in the FDA, he will encourage such legislation.

[Last modified March 13, 2005, 00:22:15]