Ever since a coalition of doctors came out against the controversial new painkiller Zohydro, health officials have been questioning how the drug got approved by the Food and Drug Administration in the first place.
Now, two senators are questioning the ethics of a series of meetings between drug companies and federal regulators, MedPage Today reports.
Senators Joe Manchin (D-W.Va.) and David Vitter (R-La.) want answers about what they call “pay-to-play” meetings in which pharmaceutical manufacturers allegedly shelled out thousands of dollars to meet with FDA officials who oversee safety regulations on painkillers. The senators suggest these meetings might have helped Zohydro get approved by the FDA despite an advisory committee voting against it.
The FDA approved Zohydro in the fall, and it’s expected to be available to patients with chronic pain starting in March. Dozens of doctors and addiction treatment groups are calling for the FDA to revoke its approval of the drug, which they say is deadly and could lead to another spike in opioid addiction.
Opponents of the drug argue that it will be prone to abuse because the pills contain a high dose of hydrocodone, a narcotic that has effects similar to heroin, and they’re reportedly easy to crush or chew for addicts who want to get a strong high quickly.
The senators want to see financial records — including any payment transfers — for groups connected to the University of Rochester that reportedly set up the meetings between drug company representatives and FDA officials, according to MedPage Today.
Zohydro’s initial manufacturer, Elan (now Alkermes), reportedly paid to send a representative to these private meetings. (The drug is marketed in the U.S. by a third company, Zogenix.)
In their letter, the senators allege these meetings gave the drug companies “undue influence over FDA’s approval process for prescription painkillers.”
University of Rochester Medical Center spokesman Christopher DiFrancesco denied to MedPage Today that these were “pay-to-play” meetings. He said participants were not allowed to discuss specific drugs and that the meetings had no bearing on the FDA’s decisions about whether or not to approve certain drugs.
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