Opioid Drug Issues

More Information on Opioid Drug Issues

• Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Intravenous Tramadol, February 15, 2022
• Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding a Hydrocodone-Acetaminophen-Promethazine Combination Product, November 2, 2020
• Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Reformulated Oxycontin, September 11, 2020
• Supplement to the Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II, May 28, 2020
• Letter to the FDA Urging the Agency Not to Approve the New Drug Application for a Tramadol-Celecoxib Fixed-Dose Combination Product for Management of Acute Pain, January 31, 2020
• Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Opioid Oxycodegol, January 14, 2020
• Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II, November 6, 2019
• Presentation at the FDA’s Public Hearing Entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction”, September 17, 2019
• Press Statement: FDA’s Double Denial Concerning Its Delinquency in Urgently Implementing Better Opioid Regulation, September 9, 2019
• Viewpoint Article Published in JAMA Internal Medicine: The Public Health Urgency of a Temporary FDA Moratorium on New Opioid Approvals, September 3, 2019
• Comments on the FDA’s Draft Guidance for Industry Entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework”, August 20, 2019
• Press Release: Responses of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group, to Gottlieb Testimony on Opioids, March 29, 2019
• Petition to the FDA for a Moratorium on Approval of New Opioids or New Opioid Formulations, March 21, 2019 (resubmitted April 5, 2019)
• Letter to the FDA Commissioner Refuting Claims Made in His Public Statement Justifying the Approval of Sufentanil Sublingual Tablets (Dsuvia), December 11, 2018
• Op-Ed in The Washington Post Regarding the FDA’s Approval of Sufentanil Sublingual Tablets: The FDA Made the Wrong Call on This Powerful, New Opioid, November 16, 2018
• Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding a Purportedly Abuse-Deterrent, Immediate-Release Form of Oxycodone, November 14, 2018
• Press Release: FDA Makes Wrong Call; Super-Strong Opioid Medication Will Be Abused and Kill People, November 2, 2018
• Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sufentanil Sublingual Tablets, a Super-Potent Opioid, October 18, 2018
• Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Sublingual Sufentanil Tablets, October 12, 2018
• Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Extended Release Oxycodone, June 26, 2018
• Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Buprenorphine Sublingual Spray, May 22, 2018
• Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Lofexidine, March 27, 2018
• Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding A New Extended-Release Oxycodone Product, July 26, 2017
• Press Statement: The FDA Should Never Have Approved Opana ER, June 9, 2017
• Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Reformulated Opana ER, March 14, 2017
• Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Regarding Extended-Release Morphine Sulphate (Arymo), August 4th, 2016
• Letter to U.S. Congress Conference Committee for the Comprehensive Addiction and Recovery Act, July 1, 2016
• Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Regarding Opioid Analgesics, May 4, 2016
• Letters to CMS and the Joint Commission Requesting Roll Back of Pain Assessment Requirements That Foster Dangerous Overprescribing of Opioids, April 14, 2016
• Statement Before the Science Board to the Food and Drug Administration Regarding Opioid Drug Products, March 1, 2016
• Public Citizen, Partners Petition FDA for Black-Box Warnings on Opioids, Benzodiazepines About Dangers of Concurrent Use, February 22, 2016
• Comments on the CDC’s Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain, January 13, 2016
• Coalition Letter to U.S. Senate Finance Committee Calls for Release of Findings of Investigation of Opioid Makers, September 16, 2015
• Testimony Before the FDA’s Analgesic and Anesthetic Drug Products Advisory Committee Meeting on Moxduo, April 22, 2014
• Letter to Senator Joe Manchin Urging Him to Investigate FDA’s Decision to Approve Dangerous High-Dose Opioid, March 14, 2014
• Letter to the FDA Asking the Agency to Keep Dangerous High-Dose Opioid Drug Off the Market, February 26, 2014
• Statement: FDA Action Benefits Industry, Perpetuates Unsafe Use of Opioid Pain Medications, September 11, 2013
• Press Release – Painkiller labels need revision, July 25, 2012