Tuesday, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed Senators Mike Braun and Joe Manchin’s FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act. The FREED Act would require scientific experts to review the controversial enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids and ensure opioids are only marketed for uses where they are both safe and effective.
“The opioid epidemic continues to devastate our country, tearing families apart, eroding communities, and claiming far too many lives. Passing the FREED of Opioids Act out of committee is a good start to ending this epidemic of preventable deaths and pushing the FDA to fix their misleading marketing of dangerous opioids,” said Senator Braun
“In 2022, more than 109,000 Americans died from a drug overdose, and nearly 80,000 of those deaths were related to opioid or synthetic opioid use,” said Senator Manchin. “I’m proud our bipartisan legislation, which would compel the FDA to prioritize public safety and fix their flawed marketing practices for dangerous opioids, has passed out of Committee. I urge my colleagues on both sides of the aisle to support this commonsense amendment that would save countless American lives from this devastating epidemic.”
Specifically, the FREED of Opioids Act would:
- Require the FDA to convene a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM), to vote on whether EERW methodology should be used in clinical trials for opioid analgesic approvals.
- Require the FDA to convene meetings of the Anesthetic and Analgesic Drug Advisory Committee to do a post-market review of opioids approved using the EERW methodology.
- Require the National Academy of Sciences to conduct a study on EERW and its effectiveness in proving the efficacy of opioids in treating chronic pain.