FDA Rebukes Efforts To Limit Access To FDA-Approved Zohydro

The FDA rebuked state and federal efforts to limit access to controversial non-abuse-deterrent pure hydrocone painkiller Zohydro ER (hydrocodone bitartrate). The drug is manufactured by pharmaceutical company Zogenix.

Zohydro ER is an opiod agonist, extended release, oral formulation of hydrocodone bitartrate approved by the FDA in October. The drug is indicated for the management of pain requiring round the clock, long term opioid treatment and for which no alternative treatment options are adequate.

The approval of the drug by the FDA in October 2013 prompted efforts from opposing groups and individuals to restrict access to the drug. The latest included an unexpected announcement from Massachusetts Governor Deval Patrick who ordered that Zohydro be banned in the state in a declaration of public health emergency. Gov. Patrick said, “We have an epidemic of opiate abuse in Massachusetts, so we will treat it like the public health crisis it is. I have directed DPH to take certain immediate actions and to give me further actionable recommendations within 60 days to address this challenge and better protect the health of people suffering from addiction and the families and loved ones who suffer with them.”

Zogenix responded immediately, saying, “We agree with Governor Deval Patrick's intention to curb the epidemic of drug abuse in Massachusetts. However, we are extremely concerned by his unprecedented action with respect to a specific FDA-approved prescription medication.… Ultimately, the ban on the prescription medication will add to patient suffering in the state.”

The move from Gov. Patrick prompted a rebuke from the FDA in turn. “A comprehensive approach must be taken by federal and state governments, public health experts, opioid prescribers, addiction experts, patient groups, and industry to effectively combat this problem. Efforts by Congress and at the state level to legislate the approval or marketing withdrawal of medications are extremely troubling,” the federal agency told Focus in a statement.

Regulatory Focus said that the FDA’s response could have major implications going forward, both for drug manufacturers and other states.