July 10, 2017

Manchin Applauds FDA Decision to Add Immediate Release Opioids to the Risk Evaluation and Mitigation Strategy

Washington, D.C. – U.S. Senator Joe Manchin (D-WV) today applauded the Food and Drug Administration’s (FDA) decision to strengthen training and prescribing practices for immediate release opioids by adding them to the FDA’s Risk Evaluation and Mitigation Strategy (REMS). Senator Manchin has fought for years to convince the FDA to recognize the dangers of opioid medications and take steps to reduce the risk to patients. This is a significant step because approximately 90 percent of the 200 million annual opioid prescriptions written are for immediate release opioids.

“One key to effectively ending the opioid epidemic is to change the way we prescribe opioids and that begins with our doctors, pharmacists and nurses,” Senator Manchin said. “I strongly support mandatory prescriber education, and I am grateful that Administrator Gottlieb will finally begin taking steps to strengthen prescriber education for immediate release opioids. This is a necessary step to start dramatically reversing the opioid crisis, but I hope that FDA will take the next step and make this education mandatory. As we know now, the risks associated with prescription opioids are high and prescriber education will enable prescribers to prescribe these powerful opiates correctly and ensure that their patients know the risks. Although this is a good first step, I believe the FDA must go further in order for us to effectively end the opioid epidemic.” 

Immediate release (IR) opioids, like Vicodin and Percocet, will now be subject to the Risk Evaluation and Mitigation Strategy (REMS), which includes prescriber education. It also expands the scope of prescriber education and extends it to nurses and pharmacists. At a meeting in May, the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted unanimously to modify the REMS, including extending it to IR opioids and making the prescriber education mandatory.

To review a timeline of Senator Manchin’s efforts in the Senate to combat prescription drug abuse, please click here.