The Washington PostDemocracy Dies in Darkness

Opinion The FDA takes a stand against an opioid that fueled an epidemic

The Food and Drug Administration campus in Silver Spring, Md. (Andrew Harnik/Associated Press)

OPIOIDS CONTINUE to ruin lives, and end them, in Maryland. New official figures show that 2,089 people died from drug and alcohol overdoses last year, a 66 percent increase over 2015. Government data for the nation as a whole are not yet available, but the New York Times recently estimated based on its own survey of state and local officials that overdose deaths last year exceeded 59,000, which would represent a 19 percent increase from 2015. The epidemic that began two decades ago with legally produced and distributed prescription drugs has given way to an out-of-control surge in illegal sales and use of fentanyl, a drug considered many times more potent than heroin, much of it originating in China, which accounted for more than half of the deaths recorded last year in Maryland.

Belatedly, those responsible for health and safety in this country have begun to rein in prescription opioids. Yet they still contributed to 418 deaths in Maryland last year, up from 351 in 2015. As those statistics suggest, the horrific advent of fentanyl should not obscure the fact that addiction to prescription medications remains a major public-health problem.

Therefore it was welcome news that the Food and Drug Administration has told Endo Pharmaceuticals to remove its opioid Opana ER from the market. The agency concluded that "the benefits of the drug may no longer outweigh the risks," consistent with the judgment reached earlier by an FDA advisory panel. Opana had become notorious as the cause of an addiction epidemic in rural Indiana that led, in turn, to a surge in HIV infections. Addicted users were converting the pills to injectable form and then sharing needles, spreading the virus.

Significantly, the FDA recommendation applies to a reformulated version of Opana, issued six years after the painkiller's debut in 2006, that Endo had claimed would be "abuse deterrent." That reformulation wasn't protective enough, in the FDA's view, and the agency had refused to let Endo label it as "abuse deterrent." Last Thursday's recommendation represents a further vote of no confidence from the agency. Endo issued a statement to the effect that it was "evaluating the full range of potential options," but we can't understand why any company would continue to sell Opana ER under these circumstances, or why the FDA would hesitate to follow through on its promise to take the drug off the market if the company won't do so itself.

The new FDA administrator, Scott Gottlieb, acknowledged at his confirmation hearings in April that the FDA had been “complicit, even if unwittingly,” in the opioid epidemic. The agency, he said, “didn’t fully recognize the scope of the emerging problem,” and he pledged a new approach. The recommendation that Endo stop selling Opana ER is a sign that he intends to keep that promise regarding the future, even if not much can be done about the past — except to learn from it.

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