Senators probe ‘pay-to-play’ allegations on FDA approval of painkillers

Sens. Joe Manchin (D-W.V.) and David Vitter (R-La.) are probing allegations that members of the pharmaceutical industry paid big money to meet with members of the Food and Drug Administration ahead of the agency’s approval of a controversial painkiller.

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The senators sent a letter on Wednesday to the Dean of the School of Medicine and Dentistry at the University of Rochester, Dr. Mark Taubman, after reports surfaced that the school arranged for members of the pharmaceutical industry to sit with FDA officials at conferences at a cost of between $25,000 and $35,000 each.

“The FDA’s approval process should not compromise patient safety for financial gain,” the senators wrote.

The senators asked for details on all payments between the organizations, and the purpose for those transfers.

The FDA oversees safety regulations for painkiller medications, and the senators are questioning whether the meetings influenced the approval of a new painkiller called Zohydro ER.

“We are also troubled by the role the pay-to-play meetings may have played in the recent approval of Zohydro ER, a controversial new prescription painkiller,” they wrote. “Zohydro ER has up to 10 times as much hydrocodone as Vicodin and Lortab and will come in a formulation that can be easily crushed, snorted and injected.”

One FDA advisory committee voted 11 to two against approving the drug.

Manchin said he sent a similar letter to FDA commissioner Margaret Hamburg last year, but did not hear back.