May 15, 2021

Manchin, Braun Bill To Address Incorrect Marketing Of Dangerous Opioids

Charleston, WV – Today, U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) reintroduced the bipartisan FDA Review of Efficacy of EERW Double-Blinds (FREED) of Opioids Act which would ensure that scientific experts review the controversial enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids and will ensure that opioids are only marketed for uses where they are both safe and effective.

“In 2020, over 90,000 Americans died from a drug overdose, and we can assume that over 51% of those deaths were related to opioids or synthetic-opioids. It’s simply heartbreaking, and we must do more to address the terrible epidemic facing our nation. Our bipartisan bill will help address the incorrect marketing of dangerous opioids that do more harm than good. I urge my bipartisan colleagues to join our legislation to help combat the opioid epidemic and ensure people are informed about the effects of dangerous opioids,” said Senator Manchin.

“The opioid crisis affects Americans in every state and all walks of life. We must do everything we can to end this epidemic of preventable deaths, and this bill to fix incorrect marketing of dangerous opioid drugs is a useful solution to help inform Americans about the possible dangers of opioid drug addiction,” said Senator Mike Braun.

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 the whether EERW methodology should be used in clinical trials for opioid analgesic approvals.
  • 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.

“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.

Senator Manchin’s recent efforts to address the drug epidemic:

  • On May 11th, Senator Manchin reintroduced the DEA Enforcement and Authority Act, which would restore the DEA ability to effectively enforce our nation’s drug laws.
  • On April 29th, Senators Manchin, Capito and King introduced the FDA Accountability for Public Safety Act which would ensure experts are heard when the Food and Drug Administration (FDA) considers new, dangerous opioid medications. Senator Manchin also called on Congress to pass permanent rescheduling of fentanyl and fentanyl related substances after the Senate unanimously passed an extension of the temporary fentanyl rescheduling through October 22, 2021.
  • On April 28th, Senator Manchin reintroduced the Protecting Americans from Dangerous Opioids Act, which would require the Food and Drug Administration (FDA) to remove one opioid medication currently on the market for every new opioid medication that they approve.
  • On April 26th, Senator Manchin reintroduced the Changing the Culture of the FDA Act, which would amend the FDA mission statement to include the agency’s responsibility for addressing the ongoing drug epidemic.
  • On April 22nd, Senators Manchin and Tim Scott introduced the bipartisan Non-Opioid Directive (NOD) Act, which would establish a non-opioid directive form that allows patients to notify health professionals that they do not wish to be treated with opioids.
  • On April 21st, Senator Manchin delivered remarks on the Senate Floor urging Congress to pass his bipartisan bill, FIGHT Fentanyl Act, which would permanently reschedule fentanyl and fentanyl related substances.
  • On March 26th, Senator Manchin led seven Senators in calling on President Joe Biden to bring in new FDA leadership to address the growing opioid epidemic that has been exacerbated by the COVID-19 pandemic.

Background information on the FREED of Opioids Act can be found here.

Bill text can be found here