Pharmaceutical

Was the FDA’s approval of the controversial painkiller Zohydro influenced by drug companies?

fda logo Was the FDAs approval of the controversial painkiller Zohydro influenced by drug companies?Two senators are pushing for an investigation into reports that pharmaceutical companies paid to attend private meetings between Food and Drug Administration (FDA) officials and medical professionals in an effort to influence the approval of the controversial new opioid painkiller Zohydro ER.

These so-called “pay-to-play” meetings, during which drug companies allegedly paid between $25,000 and $35,000 to the University of Rochester Medical Center to participate, demonstrate a clear, illegal conflict of interest that put consumer safety at risk, Sen. David Vitter said in a statement issued earlier this week. Vitter and Sen. Mike Lee are urging the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) to investigate the matter.

Zohydro is a hydrocodone-type medication in the same family of drugs as codeine, morphine, fentanyl and oxycodone. Zohydro side effects include sedation, respiratory depression, and a strong feeling of euphoria, which can make it an attractive recreational drug. Like all opioids, dependence and addiction to Zohydro can develop quickly over time.

The FDA’s approval of Zohydro last fall to treat chronic pain was met with much controversy. Speaking out on concerns of a prescription drug abuse epidemic, consumer groups, physician associations, addiction treatment organizations, and even several state attorneys general have petitioned the FDA to withdraw its approval for Zohydro.

It is concerning that the FDA may have been influenced by drug companies who would profit from the agency’s approval of Zohydro, the senators said in the statement. “The FDA approval process should not compromise patient safety for personal financial gain,” the letter states. “This certainly warrants the attention of (the HHS OIG).”

Sources:
Law360
Righting Injustice