FDA'S WEAKNESS

St. Petersburg Times: Until the interim appointment of Dr. Lester Crawford last week, the Food and Drug Administration had been waiting for a leader since President Bush took office. Meanwhile, the agency responsible for regulating products that account for one-fourth of the nation's economy has drawn increasing criticism for failing to safeguard our food and pharmaceutical supplies.
To prevent the spread of mad cow disease, the FDA was supposed to enforce a ban on feeding meat and bone to U.S. cattle. But regulators have failed to take meaningful action against feed mills and other firms that violate rules, according to the General Accounting Office. Some meat processors and cattle farms with violations went a year or more with no followup inspection. Moreover, auditors concluded that FDA's record-keeping "is so severely flawed" that "it should not be used to assess compliance."
Exemption: The agency has been falling down on drug safety as well. A recent review of a decade of FDA decisions found approved prescription drugs linked to an alarming number of deaths. The study said FDA scientists were pressured to rush approvals and to scuttle reviews once drugs made it to market. No one knows how many unregulated drugs marketed as "dietary supplements" have harmed people, because Congress has chosen to exempt the billion-dollar supplement industry from FDA's pre-approval process. Congress does direct FDA to monitor claims and labeling of supplements already on the market, but even those standards haven't been uniformly enforced.
Responsibility for strengthening the FDA begins with the White House. The president's first nominee for commissioner was a lawyer for the biotech industry, which rightly concerned Senate Democrats. Then the administration put forth Dr. Alastair J.J. Wood, an expert on drug safety, who was soon withdrawn under pressure from drugmakers who described Wood as too aggressive a regulator.
Dr. Crawford, the interim nominee, will serve as deputy commissioner and therefore avoid Senate confirmation. A veterinarian with a degree in pharmacology, Crawford has already raised eyebrows because he is not a medical doctor and because he has headed an institute heavily supported by the sugar and soft drink industries. His ties also include the past vice-presidency of the National Food Processors Association and a stint with an agricultural chemicals company. Dr. Crawford is likely to satisfy the industries regulated by the FDA, but the public benefit from his tenure is still uncertain.