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Manchin On FDA To Probe Drug Maker

October 12, 2013
By FRED CONNORS Senior Staff Writer , The Intelligencer / Wheeling News-Register

Sen. Joe Manchin, D-W.Va., is calling for an investigation of an alleged pay to play relationship between the pharmaceutical industry and FDA officials overseeing safety regulations of painkiller medicine.

In a letter to FDA commissioner Margaret Hamburg, Manchin referenced reports that private companies paid as much as $25,000 to participate in FDA advisory panel discussions on federal regulations for prescription painkillers.

Manchin's letter claimed, "If these allegations are accurate, there is a direct conflict of interest that allows pharmaceutical companies to have undue influence over the FDA's decision-making process, particularly in regards to rescheduling hydrocodone combination drugs, a highly addictive painkiller. I am gravely concerned by the allegations of 'pay to play' between the FDA and pain medicine companies and am calling for a full investigation to see how deep this goes."

He said if this is true, it explains why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone even after their own expert advisory panel recommended it.

"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," he said.

Manchin claims to have led the fight to tighten restrictions on some of the most powerful, addictive narcotics on the market. He said rescheduling hydrocodone painkillers, such as Vicodin and Lortab, from a Schedule III to a Schedule II controlled substance would accurately reflect the drugs' high potential for addiction and abuse. The FDA's own advisory board, consisting of leading scientists and experts in the field, has already completed a review and voted to reschedule the drug. However, the agency has yet to act.

He said he hopes a full senate investigation could reveal if an improper relationship between the FDA and influential pharmaceutical companies potentially caused stalling of rescheduling of highly addictive painkillers

In his letter to Hamburg, Manchin wrote, "if the FDA is seriously alleging that its conduct is proper and that payments by the pharmaceutical industry to participate in closed-door advisory panels is not impacting its decisions, then the FDA should have no problem disclosing the following information to my office in a prompt manner."

Despite the U.S. government shutdown, Manchin said he is optimistic that senate hearings could begin within a 30-60 day timeline.

"The senate is still operating," he said. "We can still work through the process. I want them to testify first to determine if people who benefit can sway public policy. If necessary, we will look deeper for a possible criminal complaint."

He said he wants to hear from Hamburg, pharmaceutical company professionals participated in the discussions and anyone else who may be involved.

"I would like to question them on how frequently they met and, if they paid $25,000 for a place at the table, where did the money go?"

Manchin said West Virginia leads the nation in prescription drug abuses and rescheduling hydrocodone painkillers from III to II would tighten doctors' ability to prescribe the drugs in large amounts.

"Drug addicts tend to abuse government assistance in order to get their prescriptions," he said. "There is some responsibility on how doctors are prescribing these drugs. We need more first class convictions in some cases."

 
 

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