FDA chief defends Zohydro approval as US states rebel

Margaret Hamburg, commissioner of the US Food and Drug Administration, has defended her agency’s decision to approve the potent long acting opioid Zohydro ER, arguing that the FDA had to balance the risks of opioid prescription abuse with “the very real medical needs of the estimated 100 million Americans living with severe chronic pain or coping with pain at the end of life, which is also a major public health problem in this country.”

In an address to the National Rx Drug Abuse Summit being held in Atlanta, Georgia, Hamburg said that the drug—an extended release formulation of hydrocodone bitartrate—offered an effective option to patients who required around-the-clock opioid treatment and for whom alternative treatments were inadequate.

She also said that because Zohydro did not contain paracetamol (acetaminophen), it did not pose the threat of liver toxicity seen with combination hydrocodone products, such as Vicodin, which did contain paracetamol.

Hamburg’s comments came as several state governors moved to severely restrict the use of Zohydro in their states, citing concerns that the drug, which can be easily crushed for sniffing or injection, would exacerbate prescription opioid abuse in their states.

On Tuesday 22 April Deval Patrick, the Massachusetts governor, issued orders to require prescribers to complete a risk assessment and agreements on pain management treatment before prescribing Zohydro. Rules issued by the Massachusetts Board of Registration in Medicine say that these agreements must address drug screening, pill counts, and safe storage and disposal.

Patrick said, “We are in the midst of a public health emergency around opioid abuse and we need to do everything in our power to prevent it from getting worse.”

His order came after a court lifted an outright ban on the drug, which Patrick imposed in March. In that ruling District Court Judge Rya W Zobel cited the Supremacy Clause of the US Constitution, which establishes that federal law supersedes state law if they conflict.

Zobel wrote, “If Commonwealth [of Massachusetts] were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health. The Commonwealth’s emergency order thus stands in the way of ‘the accomplishment and execution of’ an important federal objective.”

Zohydro’s manufacturer, Zogenix, which is based in San Diego, California, expressed disappointment at Patrick’s decision to impose restrictions that singled out its product.

“Zogenix stands ready to work with the state of Massachusetts to help address the serious problem of opioid abuse and to focus, with the governor and his team, on the root causes of the problem and the solutions most likely to make a difference. Imposing restrictions on one specific treatment, without developing a full understanding of the facts and the causes of the problem, does not serve the public interest,” the company said in a statement.

The FDA’s decision to approve Zohydro last October, despite an 11-2 vote by the agency’s advisory board against approval, triggered a storm of protests from state officials and politicians in Washington.

Late last year attorneys general from 29 states wrote a letter to Hamburg, calling for her to either revoke the drug’s approval or require the manufacturer to quickly produce a formulation that deterred misuse. And earlier this year Joe Manchin, a Democrat senator from West Virginia—a state that has been hard hit by the opioid abuse epidemic—introduced a bill that would force the FDA to withdraw its approval of the drug.