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After disclosures alerting the Food and Drug Administration that the pharmaceutical industry has been paying millions of dollars to physicians, the FDA is seeking to exclude scientists with substantial financial ties to medical device and drug companies from participating in the drug approval process.

Consumer advocates and congressional critics have sought to reduce or remove the involvement of doctors, scientists, and researchers who receive funding from drug companies from participating in FDA panels that make decisions about those companies’ products.

The policies would take effect later in the year.

Ramifications

The FDA’s deputy commissioner for policy, Randall Lutter, said, the proposal “strikes an appropriate balance” between the FDA’s need to employ experts and of ensuring that the public has faith in FDA decisions.

Researchers that receive lesser funds from the drug companies would still be able to participate in debates and attend meetings, but they would be prohibited from voting on advisory panels.

The proposal would disqualify about one-fourth of current FDA advisors from voting on the panels.

Peter Lurie, deputy director of Public Citizen’s health research group said that the change would ultimately be better for the patients because it would force the FDA to seek out scientists with no industry bias and result in “panels that are less tainted and recommendations that are more respected.”

Limitations

The bill proposes to limit doctors and researchers who have received $50,000 or more in research funding from companies with a financial stake in the FDA’s decisions. This $50,000 cap would also include stock values.

“It’s not perfect. The $50,000 is still too high,” said New York representative Maurice Hinchey, but he said it was a good first step.

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