Reports: Emails show alleged pay-to-play between drug companies, FDA
Updated at 4:45 p.m.
An Ohio attorney has obtained emails that show that pharmaceutical companies have been paying tens of thousands of dollars to attend meetings of a panel of academics and health industry regulators that advise the Food and Drug Administration on its drug policies for painkillers, according to multiple news reports.
Two medical professors, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington, set up a panel known by the acronym IMMPACT to advise the FDA on how to test the safety and effectiveness of painkillers - a $9 billion market in the United States. Pharmaceutical companies paid huge sums that could go as high as $35,000 to fund and attend meetings of the panel, the emails show. The professors collected as much as $50,000 each, which they would used to fund academic research accounts, research assistants and expenses, among other things.
In 2011, IMMPACT became a part of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, or ACTTION, a public-private partnership between the University of Rochester, academia, FDA and other government agencies, industry, professional organizations, patient advocacy groups, foundations, and philanthropic organizations, according to Steven Immergut, the FDA Assistant Commissioner for Media Affairs.
Immergut said in a statement that these sort of public-private partnerships is one of just many in which the FDA participates in order to bring together expertise from all areas of drug development for collaborations that can help identify and address knowledge gaps and foster innovation.
But for some, the e-mails raise concern about a possible pay-to-play relationship between drug companies and the FDA.
"These e-mails help explain the disastrous decisions the FDA's analgesic division has made over the last 10 years," Craig Mayton, an attorney from Columbus, Ohio, who requested the emails from University of Washington, told the Washington Post. "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."
Immergut said the FDA is aware of the concerns that have been raised about the FDA's role in public private partnerships, and that those concerns are taken seriously. " We are unaware of any improprieties associated with ACTTION or IMMPACT, or with the Agency's involvement in the public-private partnership. The involvement of FDA scientists in these consortia is consistent with their responsibilities to understand the state of the science with regard to analgesic drug discovery and development. The recent participation of Agency representatives in this consortium has focused on discussions about clinical trial design for analgesic drugs, not on matters specific to any particular analgesic product," the statement said. "With regard to selection of the ACTTION contractors, the FDA has processes in place to avoid conflicts of interest issues. We will continue to evaluate our participation in these partnerships to ensure that they foster their stated goals and that they do not present conflicts of interest."