FDA Pledges Conflict Reforms

Responding to criticism that its expert advisory panels are packed with industry-friendly scientists, the Food and Drug Administration pledged Monday to clarify its conflict-of-interest rules and provide greater public disclosure.

But critics said it was not clear that the reforms would stop many doctors and researchers with such conflicts from serving on the panels, whose recommendations can determine the fate of drugs that may be worth millions of dollars in corporate profits but also may endanger consumers.

The FDA has about 50 advisory panels that are supposed to provide impartial technical advice on issues such as over-the-counter allergy medicines, silicone breast implants and chemotherapy drugs with toxic side effects. A study published this year found that 28% of panel members disclosed financial conflicts, but only 1% recused themselves.

The latest FDA announcement comes as the issue of conflicts of interest among the nation’s scientific elite is being hotly debated.

Legislation pending in Congress would bar the FDA from employing outside experts with any financial ties to companies with a stake in a panel’s recommendation -- whether the companies sponsored the drug in question or manufactured a competing product.

Defenders of the current system, on the other hand, argue that tightening the rules too much would force the FDA to rely on scientists who lacked expertise in a particular area.

FDA Deputy Commissioner Scott Gottlieb acknowledged that there were “clearly things we can improve on,” but insisted that the agency must retain the flexibility to grant waivers from conflict-of-interest rules to get the highest quality scientific advice. Drug development has become so specialized that a relatively small number of scientists have the detailed knowledge needed to evaluate a new medication, he said, and most have worked as consultants or advisors to pharmaceutical companies at one time or another.

Instead of imposing sweeping prohibitions, Gottlieb said, the FDA is working on instructions to ensure that all its advisory committees follow the same procedures in evaluating conflicts of interest and granting waivers.

“We want to codify this in a public guidance document so people will have a reference to understand what the agency philosophy is,” said Gottlieb. The FDA also intends to make public more details about the waivers it grants to panel members.

FDA critics said they supported the proposal’s intent, but complained that the agency had not released enough detail for them to evaluate whether the changes would improve the situation.

“Having these waivers be uniform across committees is an excellent idea, but it’s hard to support that when one doesn’t know whether it would be raising the standards for everybody or lowering them to the lowest common denominator,” said Dr. Peter Lurie of the advocacy group Public Citizen.

Many FDA critics agree that it would be going too far to ban any ties between FDA advisors and industry.

Lurie, for example, would allow scientists who own company stock to serve on an advisory panel considering one of its products, provided the stock isn’t worth more than $10,000 to $25,000. But he said doctors and researchers who have served as representatives of a company should not be allowed to vote on its products.

“That’s a fair question,” said Gottlieb. “Let’s say we were able to draw a bright line around scientific endeavors versus a marketing relationship. We might want to make a decision that it doesn’t merit granting a waiver for that relationship.”

Ultimately, it may take more than a new conflict-of-interest policy to restore the FDA’s reputation, which has been tarnished by drug safety lapses such as its failure to identify the heart risks of Vioxx, a painkiller whose manufacturer withdrew it from the market. The agency needs a stronger safety program and a dedicated funding stream to wean it from its dependence on user fees paid by industry, said Dr. Steven Nissen, a top cardiologist at the Cleveland Clinic and an FDA advisor.

“The FDA is facing a crisis in public confidence after a series of revelations about drug and device safety unprecedented in the history of this previously respected agency,” Nissen said during a panel discussion sponsored by the Center for Science in the Public Interest, an advocacy group that works extensively on nutrition issues. “The American people no longer trust the FDA to protect their health.

“The entire FDA budget for drug regulation is only about $500 million and relies extensively on user fees,” Nissen added, referring to money drug companies pay for review of new drug applications. “As a consequence, the FDA is financially indebted to the companies it must regulate. This is a fundamental conflict of interest.”