States Battle with FDA over Powerful New Painkiller
Political leaders from several states are challenging the federal government’s approval of a powerful new painkiller that critics say could exacerbate the problem of prescription drug abuse.
At issue is the Food and Drug Administration’s (FDA) approval of Zohydro, the first single-ingredient, opioid-based painkiller. Unlike other hydrocodone drugs, such as Percocet and Vicodin, Zohydro does not contain acetaminophen, making it more pure and more powerful.
Public health experts have warned that Zohydro could worsen the nation’s epidemic of overusing prescription drugs unless something is done to limit its availability. That’s why Vermont and Massachusetts are trying to impose restrictions on prescribing the drug in their states.
In the case of Massachusetts, Democratic Governor Deval Patrick attempted to prohibit Zohydro’s sale altogether. But a federal judge threw out the ban, saying federal law (or more specifically the federal authority of the FDA) trumps such state restrictions.
Now, Patrick is trying other ways to limit the drug’s availability through the state Board of Registration in Medicine. That body approved a rule that requires doctors to complete a risk assessment and pain management treatment agreement with patients before prescribing Zohydro. In addition, physicians who want to prescribe Zohydro would have to participate in the Prescription Monitoring Program, which keeps tab of how many times a drug is prescribed.
In Vermont, Democratic Governor Peter Shumlin has taken similar steps by mandating, among other things, that doctors determine whether other drugs can treat a patient’s pain before resorting to Zohydro.
Attempts to ban the drug outright within state boundaries are being made elsewhere, such as Ohio, where lawmakers have introduced legislation on the subject. Members of Congress from Kentucky and West Virginia as well as from Massachusetts have introduced bills to ban Zohydro. In addition, 29 state attorneys general have asked the FDA to reconsider its approval of the drug.
More than 6 million Americans abuse or misuse prescription drugs, according to a report last year by the Trust for America’s Health. Overdose fatalities involving prescription painkillers have quadrupled since 1999, making such deaths greater in number than those caused by heroin and cocaine combined.
To Learn More:
Fearing Abuse, States Challenge FDA on Painkiller Approval (by Michael Ollove, Stateline)
Zohydro: Why This New Painkiller Could Spark Another Addiction Epidemic (by Loren Grush, Fox News)
Mass. Limits Use of the Potent Painkiller Zohydro (by Milton J. Valencia, Boston Globe)
Alarmed Healthcare Providers Ask FDA to Reverse Approval of Powerful Painkiller (by Noel Brinkerhoff, AllGov)
FDA Overrules Expert Panel to Approve High-Potency Painkiller (by Danny Biederman and Noel Brinkerhoff, AllGov)
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