In October 2013, The Washington Post and MedPage Todayboth broke stories regarding a so-called "pay-for-play" deal in which some members of the pharmaceutical industry had paid hefty sums to attend small invitation-only meetings featuring influential regulators from FDA.
For background on the story, please see Focus' 10 October 2013 article "In 'Pay-for-Access' Story, Could FDA Be Experiencing its First Scandal of 2013?"
The news immediately prompted a backlash from Sen. Joe Manchin (D-WV), who said the meetings raised his concerns that FDA regulators may have been improperly influenced by members of the pharmaceutical industry.
Now Manchin and another senator, David Vitter (R-LA), are broadening their investigation into the issue.
In a sternly worded letter sent on 26 February 2014, the senators said the allegations raised significant questions about the approval of an already-controversial painkiller drug, Zohydro. The drug is a pure hydrocodone product that currently lacks the abuse-deterrent qualities of other similar painkillers. Critics-senators among them-have raised concerns that the drug is too easy to abuse or misuse, and have petitioned FDA to remove the drug from the market.
As reported by the Post and MedPage Today, some of the pharmaceutical companies that had paid as much as $35,000 to participate in more than a dozen conferences with FDA were manufacturers of painkillers.
In October 2013, Manchin sent a letter to FDA Commissioner Margaret Hamburg demanding to know more about the alleged collusion between FDA and industry, saying that it cast a pall over some of FDA's regulatory actions with respect to painkillers.
"These allegations clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA's decision making process," he wrote. "I plan to call for a full congressional investigation into this issue to determine whether these relationships have impacted the FDA's rescheduling of hydrocodone combination drugs."
While Manchin said he has yet to receive a "complete response" from FDA regarding an October 2013 letter he sent demanding answers, he is now seeking answers from the organizers of the conference series.
In a 26 February 2014 letter to Mark Taubman, dean of the School of Medicine and Dentistry at the University of Rochester, Manchin and Vitter again raised concerns about the "pay-to-play" meetings that Robert Dworkin, a professor at the University of Rochester Medical Center, had helped to organize.
"We are deeply troubled by allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars to the University of Rochester Medical Center (URMC) for the privilege to attend private meetings with FDA officials," they wrote.
Those meetings, they said, may well have influenced FDA's decision to approve Zohydro and delay rescheduling hydrocodone as a Schedule II drug.
As part of their investigation, Manchin and Vitter asked that Taubman make records available to them indicating companies that would have attended the conferences, how much they paid to attend, expenses associated with the conferences and a list of attendees at the conferences.