The FDA has asked Endo Pharmaceuticals to remove opioid painkiller Opana ER from the market, saying that in the midst of an opioid addiction crisis, its risks outweigh its benefits. The FDA warned that if Endo chose not to, it would take steps to require removal from the market.
This is the first time the FDA has taken such a step but it may not be the last. In a warning to other drugmakers, the FDA said it will weigh the risk-benefit profiles of all approved opioid analgesic products “and take further actions as appropriate as a part of our response to this public health crisis.”
This is one of the first policy decisions by the agency since Scott Gottlieb was appointed FDA commissioner by President Trump, who had talked about the opioid crisis during his campaign.
“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said in a statement.
The decision follows the recommendation of an advisory committee that voted 18 to 8 in March that the risks of the drug were too great.
Today’s announcement said that even though Opana ER was reformulated to reduce its potential for abuse, that reformulation had not made a meaningful difference.
In an emailed statement, the company said, "Endo is reviewing the request and is
evaluating the full range of potential options as we determine the appropriate path forward...Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products."
Opana ER generated sales of $158 million for the company last year, although that was down 10% from the year before.
The FDA decision comes as a variety of lawsuits, many by states that have high rates of death due to opioid overdose, have been filed against Endo and other makers of opioids. Most claim the drugmakers oversold the benefits and downplayed the risks in their marketing of the drugs to the public and doctors.
Just last week, Ohio filed suit against Endo, Teva, Allergan, Johnson & Johnson and Purdue for alleged “fraudulent marketing practices” in selling the powerful and addictive painkillers.