Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market. Opana ER is an extended-release pain reliever often abused by those who take it. While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or heroin, Opana ER is particularly dangerous because of how people misuse it. The pill was designed to prevent would-be abusers from crushing and snorting it — a popular means of ingesting prescription opioids. Without the ability to crush and snort the drug, however, abusers turned to dissolving the pills and injecting them intravenously, leading to outbreaks of Hepatitis C, HIV, and other blood-borne diseases. In Indiana’s Scott County, for instance, the prevalence of HIV has skyrocketed since the introduction of Opana ER to the local population, with 190 new cases since 2015.
While this foray into public health is somewhat surprising — given the anti-regulatory stance of the current administration and its billionaire backers — it is precisely the type of initiative the FDA should be taking. Public health is a central part of the FDA’s mission statement, which notes that the agency “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.” Traditionally, though, the FDA’s efforts to ensure safety and efficacy have been limited to the narrow context of individual patients taking medications as directed under physician supervision. As the FDA noted in its Opana ER press release, this is the first time it has requested that an opioid be taken off the market as a result of its susceptibility to abuse and the associated public health consequences.