Letter to Sylvia Matthews Burwell, Secretary of Health and Human Services - Rejecting Zohydro Extended Release

Letter

August 28, 2014

The Honorable Sylvia Mathews Burwell
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Burwell,

Our states are experiencing an opioid addiction crisis, an epidemic that has affected too many of our families and communities throughout New England. As governors, we have acted according to the needs of our residents to combat opioid abuse in our states. In June we met to discuss regional actions we can take together to address this public health and safety crisis. One of these relates to the Food and Drug Administration's (FDA's) recent approval of Zohydro Extended Release (ER), a dangerous opioid painkiller containing pure hydrocodone in a non-abuse deterrent formulation. As our federal partner, we urge you to overturn the FDA's erroneous
decision to approve Zohydro Extended Release (ER).

We know that this crisis is about more than one drug and that a multifaceted action plan is necessary. That is why we have agreed to jointly explore a number of potential tools to address this epidemic. These include: regional data sharing among our prescription monitoring programs, regional prevention campaigns directed to the public, regional prescribing guidelines and educational campaigns to ensure safe opioid prescribing, expansion of treatment options across the region including medication assisted therapy, and increased and better coordinated law enforcement efforts.

At the same time, we must also work to prevent other easily abused and highly addictive painkillers, such as Zohydro ER, from entering the market. As you know, FDA's own panel of experts recommended against this drug's approval, citing concerns about its safety. In addition, the maker of Zohydro ER has announced plans to file approval for an abuse-deterrent formulation of the drug in the coming months. The likelihood of abuse as well as the anticipated availability of an alternative are reasonable grounds for the FDA to rescind its approval. Our
states do not need another high risk drug that will only contribute to the current epidemic of prescription drug abuse.

Additionally, we thank the FDA for its January 2013 draft guidance, "Abuse Deterrent Opioids -- Evaluation and Labeling," which has given the pharmaceutical industry a better understanding of the FDA's requirements for the approval and labeling of brand name abuse-deterrent opioid analgesics. However, we urge the FDA to issue similar guidance to address the approval and labeling of generic drugs. As you know, the opioid market in the US is approximately 90 percent generics. Once FDA approves an abuse-deterrent product, it is imperative that any entity producing a generic version should be required to show that its product has similar abusedeterrent properties.

We applaud FDA's leadership in advocating for abuse-deterrent opioids as well as Canadian officials who have pledged to take similar steps to curb the flow of easily abused medications from Canada to New England. This progress, however, is undermined by the entrance of new, easily abused opioids, such as Zohydro ER, into the market. We urge you, therefore, to exercise your authority to rescind FDA's approval of Zohydro ER.

As we struggle to combat prescription drug abuse in the region and indeed, across the country, it is essential that we do everything we can to provide our residents with the support they need for prevention and recovery. We thank you for your continued partnership in this effort.

Sincerely,

Dannel P. Malloy
Governor of Connecticut

Deval L. Patrick
Governor of Massachusetts

Margaret Wood Hassan
Governor of New Hampshire

Lincoln D. Chafee
Governor of Rhode Island

Peter Shumlin
Governor of Vermon