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# Moratorium on New, Reformulated Opioids Sought
- URL: https://www.fdaweb.com/moratorium-on-new-reformulated-opioids-sought/
- Published: 2019-03-21T12:00:00.000Z
- Updated: 2026-09-15T01:14:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143673

FDA Anesthetic and Analgesic Drug Products Advisory Committee chair **Raeford Brown**, a University of Kentucky professor, and Public Citizen Health Research Group founder and senior advisor **Sidney Wolfe** are calling on HHS and FDA to immediately impose a moratorium on FDA approval of any new or reformulated opioids. The two claim eight years of experience working with FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.

“After studying and learning during these many years,” they write in a [letter](https://www.citizen.org/sites/default/files/2474cl.pdf?ref=fdaweb.com) accompanying their 3/21 [citizen petition](https://www.citizen.org/sites/default/files/2474.pdf?eType=EmailBlastContent&eId=71f9db36-32fe-4ec5-ab16-09bdce1fa051&ref=fdaweb.com), “we have become increasingly concerned about FDA’s too often dangerously deficient oversight of these drugs. The enclosed citizen petition describes what we believe is the only public health-oriented pathway to reverse this trend…. Although we acknowledge that there are many other parties who are complicit in the deadly U.S. prescription opioid epidemic, including the pharmaceutical industry itself, wholesale distributors of prescription opioids, and industry-influenced or inadequately educated physicians, it is beyond question that FDA is also culpable.”

The petition says that in the past two decades, and most recently on 11/2/18, FDA has approved new opioids or reformulation of existing opioids when previously known risks of the drugs exceeded their known benefits. “These approvals violated FDA’s current drug approval requirements for ensuring safety and effectiveness,” Brown and Wolfe write, “and deviated from the principles articulated by the National Academies that concluded that FDA had failed to adequately ‘incorporate public health considerations into opioid-related regulatory decisions.’”

The petition says the moratorium it seeks should not be lifted until the agency has implemented the elements recommended in a 7/2017 [report](http://nationalacademies.org/hmd/reports/2017/pain-management-and-the-opioid-epidemic.aspx?%5Fga=2.207249235.1393529711.1553194697-1190844465.1553194697&ref=fdaweb.com) by the National Academies for inclusion in “a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the deadly opioid crisis in the U.S.”

FDA data show, the letter and petition say, that from 2009 to 2015, as the U.S. prescription opioid crisis was rapidly growing, the agency approved a total of 27 new or reformulated opioids. “None, so far as any reliable evidence shows, could remotely be described as a breakthrough opioid, with benefits exceeding risks,” Wolfe and Brown say. “Other recently FDA-approved opioids discussed in the petition, including Opana ER, were much more harmful than beneficial. Absent a currently nonexistent effective regulatory framework for opioids that incorporates public health considerations, FDA cannot be relied upon to approve any more opioids.”

The petition uses the agency data to demonstrate that FDA approvals of new opioid formulations “actually accelerated while there was a rapid increase in the U.S. mortality rate due to the effects of opioids, both prescription and illicit. The agency has never acknowledged the possible relationship between this increase and the approval of so many new opioid formulations in such a short period, or publicly critiqued its role in approving any specific opioid drug that then contributed to this public health epidemic.”

The petition says that almost three years after FDA asked the National Academies for help to develop a new regulatory framework for opioid review, approval, and monitoring, and more than 19 months after the National Academies’ conclusions and recommendations were published, “FDA, by its own admission, has failed to implement the National Academies’ recommendations for creating and implementing a new opioid regulatory framework. Instead, the agency has added to the existing problem of too many opioids by continuing to approve new opioids without following its own legal mandates or addressing the National Academies’ concerns about the general public health.”