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April 2, 2014
Members of Congress Seek to Overturn Zohydro ER Approval, Limit FDA’s Actions

Washington, D.C.—A bipartisan group of legislators is asking Congress to force the FDA to withdraw its approval of Zohydro ER, a controversial new painkiller. Newly introduced bills also seek to prohibit the FDA from ever again approving an opioid that is not formulated to be abuse deterrent.

The FDA approved Zohydro ET after its Anesthetic and Analgesic Drug Products Advisory Committee voted11-2 against allowing the painkiller to advance in the approval process.

Recently, Sen. Joe Manchin (D-WV) submitted a Senate bill that addresses the issue, and House legislation, deemed the “Act to Ban Zohydro,” was introduced by Reps. Stephen Lynch (D-MA) and Hal Rogers (R-KY).

“I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug. Their refusal to budge forces me to introduce legislation,” Manchin said. “Because of this painkiller’s high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country…Unless this product is reformulated to prevent abuse, I strongly believe Zohydro will only fuel addiction and death in this nation.”

In a press release, Manchin said he had sent several letters to FDA Commissioner Margaret Hamburg, as well as to Department of Health and Human Services Secretary Kathleen Sebelius, expressing concerns about the FDA’s authorization process of highly addictive drugs, including the approval of Zohydro.

“Zohydro ER is a high-dose hydrocone-only opioid narcotic painkiller that does not have an abuse-deterrent formulation,” Lynch pointed out. “Allowing access to a drug so powerful, without this critical component, creates risks for the public we simply cannot afford.”

He noted that the FDA recently has reclassified hydrocodone combination products such as Lortab and Vicodin to a more restrictive Schedule II drug and has updated labeling requirements for all extended release/long acting (ER/LA) opioid analgesics but added that Zohydro approval “is a giant step backwards at a critical time when prescription drug abuse has fast become a rampant problem across the nation.”

Meanwhile, Rogers emphasized that “while the FDA continues to send mixed signals to drug companies about the need to invest in abuse-deterrent technologies, the ‘Act to Ban Zohydro’ will make it abundantly clear—life-saving measures are critical to the development of powerful painkillers like Zohydro.”

He recounted how, in southern and eastern Kentucky, “we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths. While there isn’t a silver bullet, abuse-deterrent formulations offer common sense measures to curb the tide of overdose deaths in this country.”

In a letter to shareholders, Roger Hawley, chief executive officer of Zohydro ER-manufacturer Zogenix, called some of the arguments used by critics “false and misleading statements.”

“In reality, any drug that is not used as prescribed presents a danger to the person abusing the medicine,” Hawley wrote. “That is why we have taken extraordinary steps to support the appropriate use of Zohydro ER through a comprehensive set of industry-leading safeguards.”

The FDA approved Zohydro ER only for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.





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