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FDA Asks Pharmaceutical Co. to Pull Opioid Med From Stores
June 10—The Food and Drug Administration (FDA) is asking Endo Pharmaceutical to voluntarily remove its opioid pain medication, Opana ER, from the market—a decision applauded by U.S. Sen. Joe Manchin, D-W.Va.
He said in a release this marks the first time the FDA has asked a pharmaceutical company to remove a drug because of the public health consequences of abuse.
Prior to the FDA's decision, Manchin privately urged Endo Pharmaceuticals to voluntarily remove Opana from the market after the joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee found that the risks of the drug outweighed the benefits.
He also raised the issue directly with Commissioner Dr. Scott Gottlieb prior to his confirmation as head of the FDA.
"I am pleased to see the FDA take this unprecedented step to fight the opioid epidemic," Manchin said. "The FDA serves a critical role as the agency that oversees the approval of these addictive drugs and I have advocated for years for the FDA seek the advice of its expert advisory panel and seriously follow its recommendations concerning the approval and reevaluation of dangerously addictive drugs for public use."
He said this is a critical step, but there is more work to be done in preventing opioid addiction and in ensuring every family impacted by the epidemic has access to quality treatment facilities.
"I have seen firsthand the devastating effects prescription drug abuse have had in West Virginia and states across our nation. I will continue to do all that I can to curb this epidemic."
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