WASHINGTON (NEWS RELEASE) – Today U.S. Senator Joe Manchin (D-WV) applauded the Food and Drug Administration’s (FDA) decision to ask Endo Pharmaceutical to voluntarily remove its opioid pain medication, Opana ER, from the market. This is the first time the FDA has asked a pharmaceutical company to remove a drug because of the public health consequences of abuse. Prior to this decision by the FDA, Senator Manchin had 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 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,” Senator 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. I raised this issue with Commissioner Gottlieb and am pleased that he has taken this critical step. While removing Opana from the market is a step in the right direction, there is more work to be done to prevent opioid addiction and to ensure every family impacted by the opioid 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.”
On Thursday, the FDA asked Endo Pharmaceuticals to voluntarily remove its opioid pain medication, Opana ER, from the market. The agency concluded after an extensive review that the “benefits of the drug may no longer outweigh its risks.” In 2012, Endo Pharmaceuticals reformulated the drug to make it more difficult to snort but the FDA found that move led to more injections and a rise in both HIV and Hepatitis C infections among those abusing Opana.