March 21, 2019

**Listen to the press conference**

Immediate Moratorium on Opioid Approvals Is Urgently Needed, Say FDA Committee Chair and Public Citizen

With Dangerous Opioids Continuing to Flood the Market, a Moratorium Is Required to Stop More Abuse, Deaths

WASHINGTON, D.C. – The federal government must halt approval of all new opioid formulations until the U.S. Food and Drug Administration (FDA) takes immediate steps to prevent additional dangerous, approved opioids from flooding the market, an FDA advisory committee chair and Public Citizen said today in a petition to the agency and U.S. Department of Health and Human Services (HHS).

“We demand a moratorium on the approval of opioids out of a sense of urgency, after repeatedly attempting to provide insights concerning the opioid crisis to the principals of the FDA. Tragically, they have not listened,” said Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. “The mission of the FDA is to protect the public health. In the eyes of many experts, as it relates to opioids, they have failed.”

The petition was filed by Brown, also a professor of anesthesiology and pediatrics at the University of Kentucky, and Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group and previous member of the FDA’s Drug Safety and Risk Management Advisory Committee. Together, they have eight years of experience on FDA advisory committees, very often focusing on prescription opioids.

In a telephone press conference today, Wolfe and Brown detailed the urgent need for the FDA to implement National Academies of Sciences, Engineering, and Medicine (National Academies) mid-2017 recommendations regarding the review and approval of opioids, which the FDA asked for, before any moratorium can be lifted.  This includes developing an opioid regulatory framework to prevent a continuation of dangerous past FDA regulatory errors that have contributed to the opioid crisis in the U.S. The National Academies found that the FDA had failed to adequately “incorporate public health considerations into opioid-related regulatory decisions.”

Wolfe added, “As an important contributor to the current prescription opioid crisis because of its poor record, the FDA no longer can be trusted to approve new opioids. The moratorium will force the FDA and its advisors to actually design and implement the regulatory framework recommended almost two years ago by the National Academies, but still dangerously unfinished. To continue approving opioids such as Opana ER and Dsuvia before developing this framework for safer opioid regulations is to guarantee further opioid disasters and FDA culpability.” 

The FDA has been too quick to approve opioids, Wolfe and Brown said. The agency approved 27 new or reformulated opioid analgesic medications between 2009 and 2015 – even as the opioid crisis escalated.

In 2011, the agency approved reformulated Opana ER, despite pre-approval evidence that it could easily be manipulated to facilitate intravenous abuse. The FDA’s insupportable claim at the time of approval that this did not constitute a safety problem became its excuse for not having a pre-approval safety advisory committee meeting. The FDA then took more than six years to remove the medication from the market despite rapidly mounting evidence that the predicted intravenous abuse of the drug was leading to a public health emergency.

Most recently, Brown and Wolfe warned the agency in November not to approve a superstrong new opioid called sufentanil sublingual tablet (brand name Dsuvia), which is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. But the agency approved the medication – and in doing so violated FDA laws and regulations and ignored the July 2017 National Academies’ public health-oriented opioid recommendations, Wolf and Brown said.

Today’s petition is available here.

Wolfe and Brown’s letter to the agency is available here.