FDA’s Zohydro ER Headache Worsening: States, DOJ Question Approval

Massachusetts’ ban on the single-entity hydrocodone signals a new kind of activism by states, and there even appears to be disunity within the Obama administration about the value of the long-acting opioid as Attorney General Holder tells Congress he is “a little baffled” by FDA’s approval and will be evaluating the basis for the decision.

Massachusetts’ ban on Zohydro ER prescriptions signals a new kind of activism by states: challenging FDA’s authority to approve drugs. But it is far from the only challenge the agency faces regarding its approval of Zogenix Inc.’s single-entity hydrocodone product, with concerns now coming from within the Obama administration itself.

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