What: All Issues : Government Checks on Corporate Power : Pharmaceutical Industry : S 1082 (Food and Drug Administration overhaul) Amendment by Durbin of Illinois on limiting the number of conflict of interest waivers the FDA can issue/On agreeing to the amendment
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S 1082 (Food and Drug Administration overhaul) Amendment by Durbin of Illinois on limiting the number of conflict of interest waivers the FDA can issue/On agreeing to the amendment
senate Roll Call 156     May 09, 2007
Y = Conservative
N = Progressive
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This vote occurred on an amendment by Dick Durbin, D-Ill., one of the Senate's most progressive members. Durbin's amendment would restrict the Food and Drug Administration (FDA) to only issuing one conflict of interest waiver per advisory committee.

The FDA uses a number of advisory committees made up of outside experts (primarily scientists) to advise it on matters related to approving new pharmaceuticals. These scientists are not allowed to have a financial conflict of interest in the drug they are evaluating. However, according to the FDA, so many scientists have financial conflicts of interest that it is very difficult to fill an advisory panel, and so the agency often issues waivers of conflict of interest rules. (Financial conflicts of interest can range widely, from being on a company's payroll or having accepted speaking fees, to working at a university that accepts a pharmaceutical company's money to help fund research.) Durbin's amendment would restrict the FDA to only issuing one waiver per advisory committee.

Durbin said the advisory committee evaluating Vioxx, the painkiller eventually pulled from the market when it was discovered to have serious cardiovascular impacts, had 10 people on it with a financial conflict of interest. "Had they been removed from the deliberation, the panel would not have recommended they go back on the market, endangering the health of thousands of Americans," Durbin said. "How can you ever justify that kind of conflict of interest? Our language tightens it."

Ted Kennedy, D-Mass., another progressive member and one of the main sponsors of the underlying bill, said Durbin's amendment was well-intentioned but that an inflexible limit on the number of waivers FDA can issue is not the answer.

"The amendment would impose a one-size-fits all, one waiver per conflict, per committee," Kennedy said, noting that the FDA recently issued a policy that it would not grant waivers for financial interests that exceed $50,000.. "The FDA is already experiencing difficulty in filling vacancies on advisory committees. The Durbin amendment, no matter how well-intentioned, would worsen the problems, making it harder to fill critical vacancies and slowing the process of reviewing new medicines."

The amendment was offered to a bill that would overhaul the FDA's drug approval program. This program essentially allows pharmaceutical companies to pay the FDA to review and possibly approve their new drugs, if they are found to be safe.

The Senate rejected the amendment 47-47 (a vote only succeeds when a majority of those present vote yes). The majority of Republicans voted against the amendment, though three voted for it: Chuck Grassley of Iowa, a frequent FDA critic; Olympia Snowe of Maine; and Susan Collins of Maine. As well, a majority of Democrats voted for the amendment, though six voted against it, including Kennedy. Thus, the amendment failed, and the bill went forward without language that would have limited the FDA to one financial conflict of interest waiver per advisory committee.

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