Chairman to FDA: Painkiller's approval will lead to deaths

 

The chairman of the House Appropriations Committee on Thursday told the Food and Drug Administration (FDA) commissioner that her agency's approval of the powerful painkiller Zohydro will prove deadly.

Rep. Hal Rogers (R-Ky) said he is “perplexed” at the FDA’s approval of the drug over the objections of the agency’s own advisory panel.

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“You’re gonna have people die,” Rogers warned FDA Commissioner Margaret Hamburg during a hearing on the agency’s 2015 budget request. “I thought we learned our lesson with OxyContin.”

Zohydro is the first FDA-approved drug to use pure hydrocodone to treat chronic pain. Other combination drugs mix hydrocodone with weaker, non-addictive painkillers such as aspirin to balance out the effects. But Zohydro contains up to 10 times as much hydrocodone as other combination drugs such as Vicodin, experts say.

The FDA gave Zohydro the green light last October, despite an 11-2 vote of the advisory panel opposing approval because of concerns about the potential for abuse.

Hamburg defended the decision, emphasizing that Zohydro is approved as a Schedule 2 drug, meaning there are limits on prescriptions, refills are prohibited and there are increased security and reporting steps required in the drug’s administration.

“We’ve tried to put in place protections that will better ensure appropriate use,” she told the committee.

Still, Rogers, who said his congressional district has been “ground zero” for the national explosion of opioid-based abuse, questioned why the FDA couldn’t simply wait for an abuse-resistant version of the drug.

That is expected to happen within two years, he said.

In the meantime, Rogers pointed to a “bipartisan outcry” in response to the Zohydro approval.

“You’re swimming upstream here, in a very dangerous current,” Rogers said. 

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