Senator Seeks Probe of Drug Firms' Meetings with FDA AdvisorsOct 11, 2013
Senator Joe Manchin III is seeking a probe over so-called “pay to play” allegations over news that pharmaceutical firms paid to attend meetings with a scientific panel that advised the U.S. Food and Drug Administration (FDA) on painkillers. According to the organizer’s emails, key drug makers paid as much as $25,000 per meeting, The Washington Post reported.
In response, Senator Manchin (Democrat-West Virginia) wrote to FDA Commissioner Margaret Hamburg requesting the agency provide his office with an array of documents, including the names of the firms that paid to attend the panel’s meetings, how much they paid, and any emails sent between meeting organizers and FDA officials, The Washington Post reported. The senator has been seeking stricter limits on hydrocodone, a key ingredient in both Vicodin and Lortab, over its addictive nature and easy availability.
Some groups, including drug firms, have fought against the effort, arguing that increased restrictions could make the drugs more difficult to obtain for patients who need them, according to The Washington Post. “It is a shame that some of these companies were able to influence the FDA’s decision with a $25,000 contribution, while West Virginian families are destroyed by the addiction these pills cause,” Manchin said in a statement. The senator is also “calling for a full investigation to see how far this goes. If these allegations are true, they explain why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone.”
Senator Manchin cited a recent Washington Post report that reported drug firms paid as much as $25,000 to attend the scientific panel’s meetings, according to emails sent among organizers. The panel was involved with safety and efficacy testing policies used by the FDA and, according to a recent Washington Post report, was funded by drug makers that paid hundreds of thousands of dollars. Also, hundreds of emails obtained by a public records request revealed that drug companies paid about $25,000 to attend a meeting.
Two academics scheduled the meetings to provide the agency with advice on how to measure clinical trial evidence, according to the Washington Post. An FDA official described the group as “an essential collaborative effort.” Consumer advocates disagree, saying that the agency had become too comfortable with drug makers looking to be part of the $9 billion U.S. painkiller market.
FDA officials met privately and co-wrote papers with drug firms. According to the FDA, its officials received no financial benefit by attending the meetings, the Washington Post reported. Yet, two officials later secured positions as consultants in the pharmaceutical industry. The FDA said it was “unaware of any improprieties” tied to the group.
Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington organized the group; the emails, for the most part, involved the meetings’ financing and organizing, according to the Washington Report. The professors received about $50,000 each per meeting, which they have said went to their academic research accounts, research assistant costs, expenses, “or to cover a small percentage of faculty effort,” they said. Emails also indicated that the pair issued a proposal for both to receive honoraria of $5,000 each for a four-hour hotel meeting that was conducted near FDA offices.