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Thursday, October 9, 2014

FDA Officials Defend Zohydro Approval

The Food and Drug Administration (FDA) officials are responding to the activist group FedUP!, a coalition of doctors, addiction professionals, and loved ones of the victims of the prescription opioid epidemic, who called for the FDA Commissioner’s resignation last week. FedUp! lashed out at FDA Commissioner Margaret A. Hamburg over her decision to defend the FDA’s approval of the pure hydrocodone drug Zohydro ER. The agency approved Zohydro despite their own panel of experts voting against the drug's approval -  citing high potential for addiction.

Three FDA officials say the drug’s approval was warranted and that it is misguided to advocate for restricting the use of one opioid, instead of confronting the widespread issue of abuse and inappropriate prescribing, The Wall Street Journal reports.

In the Journal of the American Medical Association (JAMA), FDA officials wrote, “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.”

FedUp! is not the first or the only group who is against the FDA’s approval of Zohydro. Governors from five New England states, members of Congress and the Senate, and attorneys general from 28 states, have urged the FDA to amend its decision. Despite the outcry from multiple sectors, including highly informed experts in the fields of addiction and medicine, the FDA continues to stick to their guns.

In an attempt to show that the agency is making efforts to curb the epidemic, the FDA officials say the agency is addressing the need for painkillers with tamper-resistant features. Pointing out 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.”

Whether approval of the drug Zohydro was the right decision, or not is irrelevant. Certainly, no one can argue that approving the drug has helped the prescription drug epidemic. While the FDA and officials fight over what to do, people continue to lose their lives. The list of addictive medications is too extensive, the incentives for doctors to over prescribe are staggering, and the options for patients who become dependent on these drugs are minimal.

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