FDA post-market role criticized

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The editors of the Journal of the American Medical Association (JAMA) are calling for an end to the U.S. Food and Drug Administration's (FDA) role in post-market monitoring of the safety of drugs it approves.

In a tough, three-page editorial in the Dec. 1 issue of JAMA, they suggest the creation of an independent drug safety agency or board to take responsibility for safety surveillance once a drug is on the market.

"It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong" in having authorized a product, the senior editors wrote.

With 332,000 subscribers, JAMA is the nation's largest circulation medical journal.

The call to banish the FDA from post-marketing drug surveillance came from Dr. Catherine DeAngelis, JAMA's editor-in-chief, and her two top assistants -- executive deputy editor Dr. Phil B. Fontanarosa and deputy editor Dr. Drummond Rennie.

The JAMA editors are making their pitch for a "major restructuring" of the post-marketing surveillance system for drugs at a time when the FDA is under fire and congressional scrutiny amid charges that it is inappropriately influenced by the drug industry. The JAMA editors insist those concerns are real. Because of the timeliness of their editorial, it was released early online.

"To improve the necessary measures to monitor the safety of marketed drugs, the drug approval process must be decoupled from the post-marketing safety and surveillance system," Dr. DeAngelis and her colleagues said.

They called such a split "long overdue" and said the agency or board that replaces the FDA in keeping tabs on marketed drugs must be "completely independent of influence from the pharmaceutical industry, biotechnology firms and medical-device manufacturers."

"Until this occurs ... the United States will still be far short of having an effective, vigilant and trustworthy system of post-marketing surveillance to protect the public," the authors concluded.

They said that the "major problem with the current system for ensuring the safety of medications is that drug manufacturers are largely responsible for collecting, evaluating and reporting data from post-marketing studies of their own products."

Referring to the Sept. 30 withdrawal of the popular arthritis drug Vioxx by its manufacturer after studies showed it raised the risk of heart disease and stroke, the JAMA editors noted that a prominent cardiologist had published warnings of such problems in 2001.

But the FDA "never insisted on a trial to determine the extent of the problem ... and a recent investigation suggests that Merck [the manufacturer] was well aware of the dangers ... but made concerted efforts to conceal those findings," the editors said.

Dr. Al Sears, director of the Center for Health and Wellness in West Palm Beach, Fla., said the FDA has "lost credibility" to gauge the safety of drugs it has approved because of being "being too dependent on the drug companies."

"They must eliminate industry funding and create a separate agency that reviews the safety of drugs" in the marketplace, Dr. Sears said.

FDA officials could not be reached for comment yesterday about the editorial, but previously announced they were taking steps to try to strengthen the safety program for drugs on the market. They include having the Institute of Medicine conduct a thorough report and appointing a director to the FDA Office of Drug Safety, which has been vacant for more than a year.

"These initial steps are inadequate to restore the trust and confidence necessary to convince physicians and other health aprofessionals and the public that the FDA's first absolute priority is to protect the public health," the JAMA editors said.