WASHINGTON, D.C. — A Washington Post article outlining a clandestine “pay-to-play” scheme involving the Food and Drug Administration and giant pharmaceutical companies has U.S. Sen. Joe Manchin asking for a Senate investigation.
“I want to find out how they have adopted the policy of pay to play,” said Manchin.
The system outlined in the Post article indicated two professors set up a panel in consultation with members of the FDA on how to test the safety and effectiveness of prescription pain killers. Industry representatives, for the sum of $25,000, gained access to the meeting. Manchin was furious over the suggestion regulators could be influenced by leaders of the very industry they are charged with overseeing.
“This is ridiculous to have a government agency and a watchdog to approve what’s on the market to help patients and they are using these kinds of tactics,” said Manchin. “I’m not accusing anybody of doing anything wrong, but I’m certainly going to find out.”
Manchin is especially interested in the matter because for months he has sought a rescheduling of the painkiller hydrocodone. The FDA advisory panel approved the change to drop hydrocodone from Schedule 3 to Schedule 2, which would reduce the amount of the narcotic doctors could prescribe to patients at one time. Manchin said the rescheduling was approved eight months ago on a vote of 19-10 by the FDA panel. However, it’s not yet been implemented and Manchin said he’s been unable to find out why.
“This is ridiculous to have a government agency and a watchdog to approve what’s on the market to help patients and they are using these kinds of tactics.” — U.S, Sen. Joe Manchin
“If I find out that’s their reason because someone with the pharmaceutical industries who make these drugs don’t want anyone to throttle back their ability to sell as many as humanly possible,” Manchin said. “Then I’m going to be looking deeper than just changing the policy, I’m going to be looking if there’s criminal intent involved.”
Manchin sent a letter Wednesday to FDA Commissioner Margaret Hamburg outlining his questions about the reported meetings. Manchin wants to know the date, time, and location of any and all such meetings and how much participants paid the federal agency to attend. His letter also requested the companies that participated, the topics discussed, and any FDA policy that resulted from the gathering.
The Senator said he plans to seek out participants in the meetings to testify under oath at a Senate committee hearing on the investigation.