Hatch, Bennet, Donnelly, and Young Introduce Bill to Expedite Approval of Opioid Alternatives

Press Release

Today US Senators Orrin Hatch (R-UT), Michael Bennet (D-CO), Joe Donnelly (D-IN), and Todd Young (R-IN) introduced a bipartisan bill to help bring non-opioid or non-addictive pain medications and treatments for substance use disorders to patients more quickly.

In 2012, the Advancing Breakthrough Therapies for Patients Act created a safe pathway for the US Food and Drug Administration (FDA) to expedite approval for treatments that show dramatic responses in early development. Similarly, the Accelerated Approval Program allows earlier approval of drugs that treat serious medical conditions and fulfill an unmet need. While these approvals are regularly granted, there is currently a lack of clarity surrounding the approval process for alternatives to opioids and treatments for addiction. The bipartisan bill introduced today clarifies this process to bring novel, non-addictive drugs and treatments to market more quickly.

"As our nation continues to grapple with the opioid crisis that has gripped our nation, we must find alternative treatments for those individuals that live with severe chronic and acute pain," Hatch said. "Today, we have one option for severe pain: opiates. That is simply unacceptable. This bipartisan bill will cut red tape to ensure that manufacturers working to provide lifesaving alternatives are able to bring those treatments to market as quickly as possible."

"To effectively combat the opioid epidemic, we must invest in innovative approaches to provide alternative medications for pain and more treatments for addiction," Bennet said. "We've heard from patients how effective the Breakthrough Therapies designation has been in delivering innovative medical treatments more quickly, and we can do the same for those facing opioid addiction. I'll continue working with my colleagues across the aisle to pass this bill, which could be a meaningful step toward reducing opioid use."

"As the opioid crisis continues to wreak havoc on families and communities in Indiana and across the country, it's clear there's a need for new, alternative treatments for those battling chronic or serious pain," Donnelly said. "This bipartisan legislation would encourage the development of non-addictive painkillers and non-opioid painkillers to help those who critically need it, without the potential risks and side effects of highly addictive opiates. This bill would also help safely speed up the approval process at FDA to bring non-addictive treatments to market."

"As the opioid epidemic continues to devastate families in Indiana and across the nation, we must accelerate the development of non-addictive pain medications and treatment," said Young. "In the year 2016, there were at least 785 drug overdose deaths involving opioids in Indiana. That's 785 people who didn't come home to their families. This bill represents one step we can take right now to help stop this crisis and save lives."

The bill instructs the FDA to issue guidance to clarify the qualification parameters for Breakthrough Designation and Accelerated Approval and how they apply to novel, non-opioid or non-addictive pain medications and treatments for substance use disorders.