Manchin to request probe into FDA

WASHINGTON – A U.S. senator from West Virginia is calling for a Senate investigation into whether pharmaceutical companies had undue influence over Food and Drug Administration regulations of an addictive painkiller.

Sen. Joe Manchin, D-W.Va., Wednesday called for the full investigation of the FDA and employees after a reading a story in The Washington Post this week that said private pharmaceutical companies paid up to $25,000 to be allowed in FDA advisory panel discussions about regulating prescription painkillers.

If the reports are accurate, the allegations of “pay to play” could show drug makers can influence the decision-making process to the detriment of consumers, Manchin told reporters Wednesday morning in a telephone press conference from his office in Washington, D.C.

It could be why the FDA has not changed hyrdocodone from a Schedule III to the more restrictive Schedule II narcotic and why the FDA hasn’t reached a decision on reclassifying hydrocodone despite an advisory panel of experts recommended the change, he said.

Manchin, citing the drug’s impact on people, has pursued the rescheduling of hydrocodone. The change would decrease how much of the drug can be prescribed by doctors in a single prescription.

Emergency committee meetings will be requested and those in The Post articles will be subpoenaed including the commissioner and deputy commissioner of the FDA, the companies and two professors who organized the meetings are “going to put them under oath,” he said.

The senator said he was unsure if any criminal acts were committed.

“I’m sure as heck going to find out,” Manchin said.

Rescheduling hydrocodone painkillers from Schedule III to Schedule II would make it more difficult to acquire them from doctors, Manchin said.

Manchin has sent a letter to FDA Commissioner Margaret A. Hamburg informing her he will request the investigation.

“The FDA is responsible for protecting and promoting public health through the regulation and supervision of various products, including painkillers. This task requires the FDA to evaluate scientific data and put the public first,” the letter said. “These recent reports raise serious doubts about the FDA’s ability to make objective and scientifically based decisions regarding the proper treatment of prescription painkillers.”

He requested from the location, date and time of all meetings, discussion panels and conferences organized by Professors Robert Dworkin or Dennis Turk that involved the FDA, all companies that paid to attend the meetings, discussion panels and conferences, the topics of discussion at these meetings and all emails written by Dworkin, Turk and FDA Assistant Commissioner Douglas Throckmorton and others at the FDA regarding about the meetings, among other items.