Regulatory Focus™ > News Articles > FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling'

FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling'

Posted 31 March 2014 | By Alexander Gaffney, RAC 

Since the US Food and Drug Administration (FDA) approved Zogenix's non-abuse-deterrent pure hydrocodone painkiller Zohydro ER (hydrocodone bitartrate) in October 2013, groups opposed to the drug have proposed a number of ways to overrule the agency's approval order and remove the drug from the market.

Legislators have called for FDA to reconsider. They've called for the government to investigate the approval. They've called for the Department of Health and Human Services, the parent agency of FDA, to overturn the decision. And in recent weeks, they've even introduced legislation to force FDA to revoke approval.

For a complete recap, please see our 27 March 2014 story, Legislators Call for Government Investigation Into Industry Influence on FDA Approval of Painkiller.

But until now, no group has actually succeeded in limiting access to the drug. But on 28 March 2014, Massachusetts Gov. Deval Patrick made a surprising announcement: Zohydro will be effectively banned in the state until "adequate measures are in place" to ensure its safe use.

Patrick: 'An Epidemic of Opiate Abuse'

In a statement, Patrick noted an "epidemic of opiate abuse in Massachusetts," and called for a proportionate public health response.

And as part of that response, Patrick said he had directed the MA Department of Public Health to take "immediate actions" to prohibit the prescribing of Zohydro until it is satisfied that "adequate measures are in place to safeguard against the potential for diversion, overdose and misuse."

In a speech, Patrick clarified that this meant the approval of an abuse-deterrent form of the drug.

"The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large," Patrick wrote.

The move immediately prompted a response from Zogenix, which said it was "extremely concerned" by the action, which it called "unprecedented."

"We believe Governor Patrick's ban on Zohydro ER only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen," the company wrote. "Ultimately, the ban on the prescription medication will add to patient suffering in the state."

FDA: Moves 'Extremely Troubling'

The move also won a rare public rebuke by FDA, which told Focus in a statement that Patrick's actions-as well as those taken recently by US legislators-were "extremely troubling."

Calling the prevention of opioid abuse a "top public health priority" at the agency, FDA said those concerns must nevertheless be balanced with the needs of patients to access adequate and necessary therapies. "Actions to advance one should not impede the other; we must balance our efforts and apply sound science as we move forward," FDA wrote.

"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," FDA continued. "Efforts by Congress and at the state level to legislate the approval or marketing withdrawal of medications are extremely troubling."

The agency, however, declined to comment on one issue of particular importance: Does Massachusetts-or any other state for that matter-have the authority to restrict access to an FDA-approved drug?

The answer could have far-reaching implications, both for Zogenix and other drug manufacturers. Some states could, for example, follow suit and ban Zohydro, creating a state-by-state patchwork of access for pain patients.

Other states might also use the precedent to push for restrictions on drugs used to facilitate abortions or prevent contraception, such as Plan B.

While the legality of the move is likely contingent upon how the ban is designed, how FDA responds could have major implications going forward.


Patrick Statement

Zogenix Statement


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