September 07, 2023

Manchin, Braun Address Misleading Marketing of Dangerous Opioids

Washington, DC—Today, U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) reintroduced the bipartisan FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act, which 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.

“It is devastating and completely unacceptable that 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. “Our bipartisan legislation mandates the FDA to prioritize public safety and fix their flawed marketing practices for dangerous opioids. I urge my colleagues on both sides of the aisle to support this commonsense legislation and save countless American lives from this epidemic.”

“The opioid epidemic continues to devastate our country, tearing families apart, eroding communities, and claiming far too many lives. We must do what we can to end this epidemic of preventable deaths and this bipartisan legislation would push the FDA to fix their misleading marketing of dangerous opioids,” said Senator Braun

“The FDA has been putting new painkillers on the market based on improper studies that skew results in favor of approval. The methodology they're using was cooked up in private meetings with drug makers. The time for outside experts to examine the use of enriched enrollment randomized withdrawal is long overdue,” said Dr. Andrew Kolodny, Medical Director, Opioid Policy Research Collaborative at Brandeis University.

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 Products 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.

In April, Senator Manchin questioned FDA Commissioner Dr. Robert Califf on his continued complicity in the drug epidemic for using the flawed EERW opioid trial methodology and allowing disproportionate pharmaceutical influence on agency decision-making. The FDA held an Advisory Committee meeting on April 19, 2023 to allow experts to participate at the end and testify on EERW trials being conducted. Despite this initial meeting, more needs to be done.

A timeline of Senator Manchin’s efforts to address the drug epidemic can be found here.

Bill text can be found here.