FDA Requests Endo Pharmaceuticals Withdraw Opana ER From the Market

FDA, Medicare Set-Aside Blog, Opioid, Opioids on June 9, 2017 | Posted by Erin O'Neill, PA-C, JD

On June 8, 2017, the Food and Drug Administration (FDA) requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of ongoing misuse and abuse of the drug. As you will recall from our prior blog post, in March 2017, an FDA advisory committee found that the risks associated with use of Opana ER (oxymorphone hydrochloride) outweighed the potential benefits. While the exact effect of the advisory committee’s findings on the future of Opana ER was unknown at that time, the decision to request withdrawal of Opana ER represents a groundbreaking move by the FDA. The FDA has never requested removal of a opioid pain medication due to the potential for abuse.

As the FDA continues to scrutinize all opioid medications, it is possible that further actions may be taken by the FDA with respect to other opioid medications with abuse potential. These actions may include changes to medication labels, placing restrictions on use and even additional requests for withdrawal of medications from the market. The FDA has indicated that if Endo Pharmaceuticals does not remove the product voluntarily, the agency plans to pursue withdrawal of the drug approval.

As also noted in our prior blog post, Opana ER is widely used in workers’ compensation cases, and consequently was included in many Medicare-Set-Aside Allocations (MSAs). The medication is very expensive, with average wholesale pricing ranging from $2.26 per pill for the 5mg dose up to $15.69 per pill for the 40mg dose so inclusion of Opana ER in an MSA could represent a huge expense. We anticipate inclusion of Opana ER will cease with the FDA’s current notification; however, the effect of the FDA’s ongoing scrutinization of all opioid medications remains to be seen.

Additional information regarding the advisory committee’s proceedings can be viewed here.