Governors to HHS secretary: Nix that FDA nod for controversial painkiller Zohydro

Count 5 U.S. governors among the lobbyists for a turnabout on the powerful painkiller Zohydro. The New England politicians wrote Health and Human Services Secretary Sylvia Burwell last week, urging her to yank the drug's FDA approval.

Citing "an opioid addiction crisis" in their states, the governors of Connecticut, Massachusetts, New Hampshire, Rhode Island and Vermont called the FDA's Zohydro decision "erroneous." As a pure-hydrocodone, non-abuse-deterrent formula, the Zogenix drug is all but destined to be abused, they said.

The governors are far from the only critics calling for the FDA to change its mind on Zohydro. Ever since the agency approved the drug against the advice of its expert advisory committee, officials of one sort or another have been taking shots at the agency and the painkiller.

Massachusetts Gov. Deval Patrick

Massachusetts Gov. Deval Patrick went so far as to ban Zohydro, though that decision was quickly squashed in court. Vermont Gov. Peter Shumlin issued an emergency rule requiring prescribers to take particular care in handing out Zohydro scripts. And a group of 28 state attorneys general lobbied the FDA to reconsider its Zohydro nod.

Zogenix has rolled out a set of tactics designed to keep Zohydro out of the hands of potential abusers, and it has amped up its development of a tamper-resistant version of the drug. But those measures have done little to quell the criticism. Ditto the FDA's repeated backing of the drug as an important alternative to other pain meds.

"As our federal partner, we urge you to overturn the FDA's erroneous decision to approve Zohydro Extended Release," the letter states, going on to say, "The likelihood of abuse as well as the anticipated availability of an [abuse-deterrent] alternative are reasonable grounds for the FDA to rescind its approval."

Given the agency's steadfast defense of the Zohydro approval, the HHS letter isn't likely to cause an overnight switch. Meanwhile, Zogenix is well aware of New England's lack of hospitality for Zohydro. Last month, the company said it was hunting for a marketing partner to help it promote the drug--and in the meantime, plans to shift its marketing resources away from New England. The region is by far the weakest in Zohydro sales.

- see the release from Rhode Island
- read the governors' letter to the HHS (PDF)

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