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# Wolfe Criticizes FDA and Endo Over Opana ER Debacle
- URL: https://www.fdaweb.com/wolfe-criticizes-fda-and-endo-over-opana-er-debacle/
- Published: 2017-06-12T12:00:00.000Z
- Updated: 2026-09-14T22:28:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138905

Public Citizen senior advisor **Sidney Wolfe** is [criticizing](http://qz.salsalabs.com/dia/track.jsp?v=2&c=LG9r8SnP1R83YQ78U%2BV7lSwBAXzIJ8dA&ref=fdaweb.com) FDA for originally approving Endo Pharmaceuticals’ controversial pain drug Opana ER (oxymorphone hydrochloride extended release) while condemning the company for being defiant in announcing that it is reviewing the agency’s request ([see earlier story](https://www.fdaweb.com/fda-wants-opana-er-pulled-from-market/)) to remove the product from the market. At the time of its initial approval, Wolfe had called the FDA decision a mistake. “Prior to approval, the FDA never presented Opana ER to its Drug Safety and Risk Management Advisory Committee, which might have advised rejecting it,” he says. Additionally, Wolfe [testified (PDF)](http://qz.salsalabs.com/dia/track.jsp?v=2&c=623atcUA0c3Ynte9AaDSD%2FkhWiK5EMrF&ref=fdaweb.com) about the drug in March before a joint meeting of two FDA advisory committees.