Doctors, manufacturers, money and the FDA

May 1, 2007

Recent regulations may bar, for the very first time, expert advisers to the FDA who receive money from either a pharmaceutical or device manufacturer from voting to approve that company's products.

He treats not only his own patients, but is referred many patients from his colleagues, who respect his clinical skills as well as his successful research program and advisory status with the Food and Drug Administration (FDA).

What Dr. Biologic's peers are not aware of is that he provides advice to the FDA on the very drugs that are part of his extensive and lucrative research program.

FDA advisers may be excluded

Recent regulations may bar, for the very first time, expert advisers to the FDA who receive money from either a pharmaceutical or device manufacturer from voting to approve that company's products.

New rules would bar physicians who receive $50,000 from a company or its competitor from joining an FDA committee or participating in discussions of such drugs or devices. In fact, the FDA acknowledges that a significant number of the agency's current physician advisers would be affected by such a policy. Since such advisory boards recommend drugs and devices for approval, and in rare cases for removal, such influential votes can have enormous impact on both the physician's and the manufacturer's income.

Such tightened FDA regulatory changes are evolving in response to a chorus of critics who contend that both drug and device manufacturers have "hijacked" the FDA's approval process by paying physicians who serve on these important advisory panels. According to The New York Times, 10 of 32 physician advisers who voted in 2005 to allow Bextra (Pfizer) to remain on the market and Vioxx (Merck) to return to the market (despite known safety concerns) had taken money from the very companies that manufactured these drugs.

Doctors as consultants

It is well known, and of no surprise, that pharmaceutical companies routinely hire physicians as consultants for both marketing and research purposes.

In Minnesota, at least 20 percent of licensed physicians in that state received income from drug manufacturers between 1997 and 2005. The average income received was $10,000.

While the old FDA rules had a prohibition against advisers owning $100,000 or more of the involved company's stock, the agency could, and often did, waive such financial conflicts. Furthermore, such conflicts, and the waiver of them, were generally not disclosed. The public never knew whether an advisor received nothing, $10 or $100,000. Under the new rule, although waivers are still possible, they can only be approved by the FDA Commissioner, something most feel will rarely occur.

Boosting consumer confidence

Officials feel that advisory panels are important to the FDA, not so much because they provide the FDA with expert advice, but more because they are thought to increase the public's confidence in FDA decisions.

FDA officials have long contended that physician advisory panels help the public understand the many factors it must consider in its decisions. Advisory panels, it is argued, are a crucial means by which the agency pulls back the curtain on its decision-making process. If physician advisers to the FDA are helping to make decisions on the very drug and device manufacturers that lucratively pay these advisers, the public's confidence in those physicians, their advice and the FDA that seeks such advice would likely be hurt.

Times are changing, and Dr. Biologic may as well get used to the changing FDA approach.

Dr. Goldberg is the director of SkinLaser & Surgery Specialists of New York and New Jersey; director of Mohs surgery and laser research, Mt. Sinai School of Medicine; and adjunct professor of law, Fordham Law School.

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