Big Pharma Paid to Attend FDA Advisory MeetingOct 7, 2013
Pharmaceutical firms funded a scientific panel that advised federal regulators, according to several media reports.
The panel, which was involved with the safety and efficacy testing policy used by the U.S. Food and Drug Administration (FDA), was funded by key drug makers, which paid hundreds of thousands of dollars, according to the Washington Post. Hundreds of emails obtained by a public records request reveal that Big Pharma paid as much as $25,000 to attend a meeting.
The meetings were scheduled by two academics with the intention of providing the FDA with advice on how to measure evidence provided from clinical trials. In fact, according to the Post, an FDA official described the group as “an essential collaborative effort.”
Consumer advocates say the FDA was too cozy with drug makers seeking to enter the United States’ $9 billion painkiller market, according to the Post. FDA officials met privately and co-authored papers with drug companies. According to the FDA, its officials received no financial benefit from participating in the meetings; however, according to the Post, two officials later secured positions as pharmaceutical consultants. The FDA issued a statement that “we take these concerns very seriously.” But, it said, “we are unaware of any improprieties” tied to the group.
The group was created by Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington. The emails generally discussed the financing and organizing of the meetings, the Post reported. The professors received about $50,000 each per meeting, which went to their academic research accounts and covered costs for research assistants and expenses “or to cover a small percentage of faculty effort,” the pair stated. The emails also indicated that the two had issued a proposal for which they had each received a $5,000 honorarium for a four-hour meeting at a hotel near the FDA offices, according to the Post.
According to the Milwaukee-Wisconsin Journal Sentinel, some drug companies paid up to $35,000 each to send a representative to the IMMPACT meetings. There, they could talk about clinical trial testing procedures with officials from the FDA and other government agencies. IMMPACT's stated goal is to reach an improvement of clinical trial design for the development of new pain medications.
Michael Carome, director of health research for the watchdog group Public Citizen, pointed out that the emails raise issues concerning the so-called “pay-for-play arrangement” that involves drug makers purchasing access to invitation-only events that afforded them meetings with FDA officials as well as opportunities to impact FDA pain drug policy, the Sentinel reported. "The whole picture is a troubling one and it warrants an independent investigation," said Carome, who has seen the emails.
In an interview, Douglas Throckmorton, the FDA's deputy director for regulatory programs, said agency officials in attendance at the meetings were not setting policy and were simply listening to scientists. "Pay-for-play is just not the way the FDA operates," Throckmorton said, according to the Sentinel. "That's not part of the culture of the FDA."
Meanwhile, in a 2003 email written by Raymond Dionne, an official with the National Institutes of Health (NIH), he discussed the closed, invitation-only meetings and suggested an open public meeting at the NIH, the Sentinel wrote. "The major advantage of having the meeting on the NIH campus would be the ability to open the meeting to all interested parties and avoid the stigma that this initiative is a 'pay to play' process," Dionne wrote in his email.