Dr. Sidney Wolfe of Public Citizen’s Health Research Group Calls on FDA to Adopt National Academies Recommendations
WASHINGTON, D.C. – An article published today in JAMA Internal Med explains the public health urgency for an immediate, temporary moratorium on new opioid approvals.
More than three and a half years ago, the U.S. Food and Drug Administration (FDA) requested the National Academies of Science, Engineering and Medicine (National Academies) to help the agency develop an improved opioid regulatory framework. The FDA received detailed recommendations from the National Academies more than two years ago. These recommendations could lead to more effective opioids that not only are safer for patients when used as indicated, but also are reviewed and tested with more focus on deterring opioid abuse.
In addition, the National Academies panel concluded that some previously approved opioid formulations might need to be removed from the market because they were unlikely to meet standards recommended for inclusion in a new framework for opioid regulation.
Because of the FDA’s dangerous delay in implementing National Academies’ recommendations, in April 2019, the Public Citizen’s Health Research Group filed a petition with the FDA and the U.S. Department of Health and Human Services to “immediately impose a moratorium on approval of all NDAs [new drug applications] for new opioids or new opioid formulations,” not to be lifted until the agency “has implemented the elements recommended by the National Academies for inclusion in the currently non-existent opioid regulatory framework.”
According to Dr. Sidney Wolfe, author of the JAMA Internal Medicine article and founder of Public Citizen’s Health Research Group, “A temporary moratorium on new opioid approvals could be brief if the FDA would make the implementation of the National Academies’ recommendations the priority that it should have been since 2017. For the FDA to continue approving new opioids before the new regulatory framework is in place is to be blind to the agency’s previous opioid approval mistakes and to risk the public’s health by repeating them.”
The article cites the recent approvals of sublingual sufentanil (Dsuvia) and the now-banned reformulated oxymorphone (Opana ER) as examples of the FDA’s previous serious approval errors, relating them to the deficient opioid regulatory process.
At 10 a.m. EDT Tuesday, the article will be available for free for 10 days here.
The petition is open for public comment through Sept. 13, 2019. https://www.regulations.gov/searchResults?rpp=25&po=0&s=FDA-2019-P-1783-0001&fp=true&ns=true.