A U.S. Senator has accused the Food and Drug Administration of having an “improper relationship” with the pharmaceutical industry and has called for a congressional investigation of fees charged to drug makers to attend agency meetings.
The Washington Post reported last week that companies paid as much as $25,000 to attend meetings of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT), a quasi-government panel set up by two academics to give advice to the FDA on clinical drug trials, many of them involving prescription painkillers. The group was organized by two medical professors, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington.
“These allegations clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA’s decision making process,” wrote Sen. Joe Manchin, a West Virginia Democrat, in a letter to FDA commissioner Margaret Hamburg.
“These recent reports raise serious doubts about the FDA’s ability to make objective and scientifically based decisions regarding the proper treatment of prescription painkillers. Even worse, when challenged by another federal agency, the National Institutes of Health, on the stigma of this “pay to play process,” the FDA balked and continued with the arrangement.”
The fees came to light after hundreds of emails were obtained through a public information request to the University of Washington.
“These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years,” said Craig Mayton, an Ohio attorney who made the public records request.
“Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written,” Mayton told The Washington Post.
The emails between Professors Dworkin and Turk also show that some drug makers balked at paying the fees, but did so anyway to be able to attend the meetings. Dworkin and Turk said the fees were necessary to help pay for the meetings and their research.
As many as 14 representatives from pharmaceutical companies attended the meetings in the Washington DC area, which focused on measuring the effectiveness of painkillers.
“If these allegations are accurate, there is a direct conflict of interest that allows pharmaceutical companies to have undue influence over the FDA’s decision-making process, particularly in regards to rescheduling hydrocodone combination drugs, a highly addictive painkiller,” wrote Sen. Manchin in his letter the Hamburg.
Manchin’s home state of West Virginia has been hit particularly hard by the prescription drug abuse epidemic. A recent report found that drug overdoses quadrupled in West Virginia over the past decade.
For several years Manchin has been urging the FDA to reschedule hydrocodone – one of the most abused painkillers – from a Schedule III controlled substance to a Schedule II drug, which would make it harder to get.
Manchin said he was concerned that the FDA’s relationships with drug makers may have slowed the rescheduling of Vicodin and other hydrocodone combination drugs. In January, an FDA advisory panel voted 19 to 10 to reclassify hydrocodone products. The FDA, which usually follows the recommendations of its advisory panels, has yet to make a final decision on the matter.
“I continue to be frustrated with the amount of time the FDA has taken to properly schedule these drugs,” Manchin said.
In a statement, the FDA said “we are unaware of any improprieties” involving the IMMPACT group.
In an interview with The Washington Post, FDA deputy director Douglas Throckmorton called IMMPACT “a private group” and said that government rules of transparency and funding did not apply to it.