State Attorneys General Seek to Have FDA Approval of Zohydro Overturned

According to a story on the Atlanta Business Chronicle’s Capitol Vision blog, the Georgia Attorney General, along with Attorneys General from Florida, Illinois, Indiana, Kentucky and Maine, are asking the Department of Health and Human Services to overrule the FDA’s approval of the potent painkiller Zohydro.

These state Attorneys General have expressed concern that Zohydro will compound the prescription drug abuse epidemic in the United States because it is 5-10 times more potent than current available painkillers, such as Vicodin.  However, unlike other painkillers, Zohydro is not mixed with other medications (such as acetaminophen) and because of this pure form is more susceptible to abuse.

In response to these concerns, Zohydro has assembled an oversight board comprised of medical, addiction and law enforcement specialists who will, according to an ABC News article “be able to spot early signs of misuse using data from sources that include prescribing statistics, addiction center reports and law enforcement records.”

At a Health Law Institute seminar co-sponsored by the State Bar of Michigan Health Law Section earlier this month, US Attorneys from the Eastern and Western Districts of Michigan expressed concerns related to the release of Zohydro and the potential for escalation of an already significant prescription drug abuse problem in Michigan.  The US Attorneys also indicated that they would be closely scrutinizing physicians who prescribe Zohydro.

Pain management physicians and other physicians who think that Zohydro would benefit their patients should be aware of this increased scrutiny.  Because of the increased focus on prescription drug abuse in general, physicians who regularly prescribe narcotics should develop compliance policies and procedures, including pain management contracts, urine testing and regular use of prescription monitoring databases such as the Michigan Automated Prescription System (MAPS), to ensure that the narcotics they prescribe are for bona fide pain management and not contributing to prescription drug abuse.

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