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Congress Protests FDA’s Approval of Highly-Addictive Zohydro

A letter signed by Democrats and Republicans to Health Secretary Kathleen Sebelius urges the FDA to reconsider its controversial decision.

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FDA's approval has caused controversy
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By John Lavitt

12/02/13

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As a founding co-chair of the Congressional Caucus on Prescription Drug Abuse, Congressman Stephen F. Lynch of Massachusetts co-authored a bipartisan letter protesting the FDA’s recent approval of the highly-addictive prescription painkiller Zohydro. Signed by seven other members of Congress, the open letter was sent to Health and Human Services Secretary Kathleen Sebelius on November 22, 2013. Although The Fix believes this is a step in the right direction, it most likely is only the beginning of a long battle against this new and extremely dangerous legal narcotic.

Made by Zogenix, Zohydro is the first pure hydrocodone prescription drug to ever be approved by the FDA and the resulting opportunities for abuse are staggering: Zohydro can be chewed, snorted, or injected by addicts to deliver a powerful dose of hydrocodone and a high on par with heroin. Pointing out the FDA’s advisory panel’s negative recommendation of Zohydro, the letter highlights an almost visceral apprehension over this likelihood for abuse.

Lynch and his fellow members of Congress reveal a strong awareness of the prescription drug epidemic, explaining, “Substance abuse is exacting a toll on America. The Centers for Disease Control and Prevention reported that there were 38,329 drug overdose deaths nationwide in 2010 and that prescription drugs were involved in nearly 60 percent of those deaths," they said. "The report also details that, consistent with previous years, opioid drugs, which include OxyContin and Vicodin, contributed to 3 out of 4 medication overdose deaths.”

Given the terrifying record of OxyContin abuse before a tamper-resistant form became available in 2010, some have expressed shock that Zohydro lacks such precautions. Although Zogenix has "started the development of an abuse deterrent formulation of Zohydro ER,” according to president Stephen Farr, such a process will not be finished and brought to market for one to three years.

In light of this pledge by Zogenix to make a tamper-resistant form of the drug, the letter asks for the FDA approval process of Zohydro to be placed in a holding pattern until the necessary safeguards can be instituted. Such a request seems to be more than reasonable given the obvious public risk. The bigger question is why the FDA approved such a dangerous narcotic in the first place and why the negative recommendation of their own expert advisory panel was ignored.

In addition to Lynch, the letter's co-signers include Harold Rogers (R-KY), Nick R. Rahall (D-WV), William R. Keating (D-MA), Vern Buchanan (R-FL), John F. Tierney (D-MA), Michael E. Capuano (D-MA), and James P. McGovern (D-MA).

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