The Food and Drug Administration shocked lawmakers, advocates and the pharmaceutical industry when it asked a drugmaker to pull an opioid from store shelves.
The agency’s decision Thursday evening to ask Endo Pharmaceuticals to remove the painkiller Opana Extended Release from the market — the first such request by the FDA — came after years of lawmakers saying that the FDA approved too many opioids and contributed to a growing epidemic.
“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 re-evaluation of dangerously addictive drugs,” Sen. Joe Manchin, D-W.Va., said Friday.
The agency’s decision on Opana came after a group of experts voted 18-8 in March that the long-acting painkiller was doing more harm than good.
In announcing the decision, new FDA Commissioner Scott Gottlieb said the FDA must “take all necessary steps to reduce the scope of opioid misuse and abuse.”
About 33,091 people died from opioid overdoses in 2015, a 17 percent increase from the 28,064 deaths in 2014, according to federal data.
Advocates cheered the FDA move as well, but with some heavy skepticism about what comes next.
Longtime agency critic Andrew Kolodny told Forbes that the question now is “Will they stop here? Because there are some opioids where at least the upper doses should come off the market.”
Consumer advocacy group Public Citizen applauded the move, but with a major caveat that the drug shouldn’t have been approved in the first place in 2006.
“Opana ER is an extended-release painkiller with significant injection abuse potential that has been linked to a number of deaths and hospitalizations during our national opioid epidemic, as well as an outbreak of HIV infection because of injection abuse,” the group said.
Opana was reformulated in 2012 to make the drug harder to snort or chew, common ways users get a quicker high. But the problem was that it made it easier to inject.
Endo doesn’t have to pull the drug, even though it now faces generic competition and only generated about 5 percent of its gross revenue last year.
While Endo doesn’t have to pull the drug, if the company spurns the FDA, the agency could call a hearing on the proposal to withdraw it.
An administrative law judge could then decide that the drug should be withdrawn and then forcibly removed from the market.
Endo said the expert panel never recommended the FDA pull the drug but instead that it include new regulatory restrictions for mitigating misuse.
The company’s stock price took a hit, with shares falling 15 percent after the decision.
Shares of other opioid makers were down on Friday such as Depomed, which fell by 5.24 percent, and Insys, which fell by 4.3 percent.
The agency wouldn’t say if it plans to take action on more opioid products. It is looking into other oxymorphone products, which is the active ingredient in Opana, said spokeswoman Sarah Peddicord. “The FDA’s work to assess the benefit-risk framework for all opioid medications is part of a broader administration-wide strategy to combat opioid abuse.”
