March 19, 2019
Thursday Telepresser: Unprecedented Action Needed to Curb the Opioid Crisis
Public Citizen and an FDA Advisory Committee Chair Will Call on the HHS and FDA to Take Urgent Measures to Curb Opioid Abuse
WHAT: Telephone press conference at which a U.S. Food and Drug Administration (FDA) advisory committee chair and a Public Citizen expert will urge that the U.S. Department of Health and Human Services (HHS) and the FDA take immediate measures to prevent additional dangerous, approved opioids from flooding the market to the detriment of public health.
Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, and Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group and previous member of FDA’s Drug Safety and Risk Management Advisory Committee – whose experience together comprises a total of eight years as special government employees on FDA advisory committees focusing heavily on prescription opioids – will detail the urgent need to implement National Academies of Sciences, Engineering, and Medicine (National Academies’) recommendations regarding the review and approval of opioids. 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 FDA has been too quick to approve opioids, Wolfe and Brown will say, including approving 24 new or reformulated opioid analgesic medications between 2009 and 2015 as the opioid crisis escalated. Most recently, Wolfe and Brown 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 – violating FDA laws and regulations and ignoring the July 2017 National Academies’ opioid recommendations.
WHEN: 1 p.m. EDT, Thursday, March 21
WHO: Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee
Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, who served on FDA’s Drug Safety and Risk Management Advisory Committee from 2008 to 2012
CONFERENCE INFO: Dial-in: 800-875-3456
Verbal Passcode: BRAD20812