FDA Officials: Zohydro Approval Warranted

After a group of activists called on the head of the Food and Drug Administration (FDA) to quit over the approval of the painkiller Zohydro, three FDA officials say the drug’s approval was warranted.

The officials say it is misguided to advocate for restricting the use of one opioid, instead of addressing the underlying issue of widespread abuse and inappropriate prescribing, The Wall Street Journal reports.

Last month, a coalition called FedUp! called on FDA Commissioner Margaret A. Hamburg to quit. The coalition, comprised of doctors, addiction specialists and family members who have lost loved ones to prescription drug overdoses, criticized Hamburg’s defense of the FDA’s decision to approve Zohydro ER, a pure hydrocodone drug. Zohydro was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction.

The FDA officials wrote in the Journal of the American Medical Association, “The problem of opioid overdose demands well-informed policies. The actions taken by FDA may help to reverse the epidemic…Policies that focus on a single drug can divert focus from broader, further-reaching interventions… The concerns over Zohydro ER should be seen in the greater context of the opioid epidemic. Singling out one drug for restrictions is not likely to be successful.”

In the opinion piece, the FDA officials say the agency has taken steps to address the need for painkillers with tamper-resistant features. They note that “although this is an appealing policy solution, the science of abuse deterrence is uncertain and evolving… No marketed opioid with purported abuse-deterrence technologies has been shown to deter oral abuse – the most common route – or to reduce addiction or death.”