A pair of Republican senators is requesting the Department of Health and Human Services Office of Inspector General (HHS OIG), a government watchdog, investigate claims that pharmaceutical companies paid a university to attend private meetings between the U.S. Food and Drug Administration (FDA) and medical professionals to influence the approval of controversial opioid painkiller Zohydro ER. Senators David Vitter, R-La., and Mike Lee, R-Utah, asked the government in a letter to open an investigation into what they referred to as “disturbing” media reports that drug companies had paid between $25,000 and $35,000 to the University of Rochester Medical Center (URMC) to participate in private meetings between medical experts and the FDA. Sen. Vitter said in a statement:
If the allegations are true, FDA officials could be involved in a clear, illegal conflict of interest with these pharmaceutical companies that puts consumer safety at risk. This certainly warrants the attention of [the HHS OIG].
The two Senators said that participation in “pay-to-play” meetings would give the pharmaceutical companies “undue influence” over FDA policy and its approval process and constitute an improper relationship between FDA employees and industry. The letter asked the OIG to investigate:
A report to Congress was requested to be sent by the end of this month. The letter said that “the FDA approval process should not compromise patient safety for personal financial gain.” The Senators’ letter did not mention any specific drugs or pharmaceutical companies. Sen. Vitter noted that this letter was meant to accompany a late-February message he and Sen. Joe Manchin, D-W.Va., sent to the named university, which specifically questioned the role meetings between the medical center and the FDA had played in the agency’s approval of Zohydro ER.
The potent painkiller, manufactured by Zogenix Inc., was approved by the FDA in October of last year, even though the agency’s own Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2 against its approval in a nonbinding recommendation. The entire approval process was surrounded by controversy. There was outrage from dozens of state attorneys general and consumer groups, as well as opposition from prominent lawmakers, citing the potential for abuse and overdose. You may recall that in December of last year 28 state attorneys general asked the FDA to reconsider approval of Zohydro.
Zohydro contains between five and 10 times more of the semi-synthetic opioid hydrocodone than common existing hydrocodone-based painkillers such as Vicodin or Lortab. The drug lacks the abuse deterrents that have been built into drugs like the revised version of OxyContin, the narcotic pain reliever blamed for a skyrocketing rate of prescription drug overdoses in recent years.
Those who have objected to the drug’s approval urged the FDA to take action. The agency’s options include revisiting its approval decision or limiting how the drug is marketed and prescribed. The objectors are also calling for the setting of a timeline for the development of an abuse-resistant reformulation. Some have even called for the U.S. Department of Health and Human Services, the parent agency of the FDA, to exercise a rare veto over the approval.
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