In the face of mounting abuse concerns, Endo Pharmaceuticals voluntarily removed Opana ER, an opioid painkiller, from the market on July 6, less than a month after the FDA requested the manufacturer take such action. It was the first opioid drug the agency had ever requested be removed over abuse concerns. The drug is a long-acting formulation of the powerful opioid oxymorphone. The drug originally was approved in 2006 and reformulated in 2012, with the intention of making the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. However, the new formulation produced dangerous, unintended consequences. The 2012 formulation of Opana ER caused abuse patterns to shift from nasal to injection, which led to an outbreak of HIV and hepatitis C infections, as well as thrombotic microangiopathy. In a June 13 letter, FDA Commissioner Scott Gottlieb, MD, wrote that the agency will be reviewing all abuse-deterrent opioids to make sure “these products are having their intended impact on limiting abuse and helping to curb the [opioid] epidemic.” In a statement, Endo maintained the safety of the product when used effectively, but said it will work with the FDA to transition patients to safer alternatives.
Gottlieb has taken several other steps since taking over the FDA. In a recent FDA statement, the new commissioner pledged to improve the safety of compounded drugs. The FDA initially increased oversight of compounded agents in 2012, after a fungal meningitis outbreak was traced back to a contaminated compounded steroid injection made by a Massachusetts company. More than 800 people became sick, of whom 64 died. The FDA increased scrutiny of compounding pharmacies as part of the Drug Quality and Security Act of 2013, a process that Gottlieb pledges to continue by active oversight of compounders.
Finally, Gottlieb has pledged to eliminate the backlog of orphan drug designation requests by releasing “modern and risk-based tools” to assess new treatments for rare diseases. There are about 200 orphan drug designation requests that the FDA has not addressed.