November 28, 2004

Drug Regulators Too Low on Independence Dosage

In the face of growing public distrust, the U.S. Food and Drug Administration remains unpersuasive in claiming that its review of prescription drugs is sufficient or places the consumer first.

Before Congress last week, an FDA drug safety reviewer testified that "the FDA as currently configured is incapable of protecting America against another Vioxx." Physician David Graham also had warned, prior to Merck's voluntary recall of the drug Sept. 30, about the painkiller's ability to increase the risk of heart attack and stroke.

Aware of Vioxx's risks, the FDA - as it did after reports this year that confirmed long-known dangers related to antidepressants - failed to act in the interest of the consumer before and after the drugs were approved. Sen. Jeff Bingaman, D-N.M., criticized FDA's culture as being one in which the agency is supposed to regulate the pharmaceutical industry but instead sees the industry as "its client." No wonder, given the FDA's reliance on drug company fees for $210 million last year, $10 million more than the agency spent on the drug approval process. According to the FDA's records, nearly 60 percent of last year's "user fee" revenue went toward salaries and benefits.

The too-cozy relationship between the FDA and drug-makers is not new. As USA Today reported in 2000, most members of FDA expert advisory panels have financial interests in the drugs or topics they are asked to evaluate. An editorial in the upcoming Journal of the American Medical Association points out that since 1992, when the FDA began charging drug companies user fees, "median approval times for standard (i.e. 'nonpriority') drugs decreased from 27 months in 1993 to 14 months in 2001," while after-the-fact drug recalls increased.

While patients benefit from speedier release of life-saving and life-sustaining medications, the FDA does them a disservice by concealing information about life-threatening aspects of a drug. Patients and physicians need more comprehensive information - good and bad - and less advertising. JAMA also criticizes the FDA's MedWatch program, which is intended to monitor adverse side effects after a new drug has been in widespread use, as "passive." It wrongly relies on drug manufacturers to collect and report negative data about their own products.

The Institute of Medicine is reviewing the FDA's "post-marketing surveillance program" and may recommend changes to the agency's approach to drug safety. One idea is to add an independent board that would review FDA approvals of drugs. Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said in a recent statement that his office and the Office of New Drugs, which reviews new drug applications, already have a healthy independence from each other. The Office of New Drugs has yet to prove such necessary independence from pharmaceutical companies.