U.S. Sens. Orrin Hatch (R-UT) and Todd Young (R-IN) have introduced a bipartisan bill designed to simplify and streamline the federal drug approval process so that non-addictive and non-opioid treatments can make their way into patients’ hands faster.
“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,” Sen. Hatch said.
Currently under the Advancing Breakthrough Therapies for Patients Act of 2012, the U.S. Food and Drug Administration (FDA) upon request may expedite the development of and provide for priority review of drugs to speed their availability to treat serious diseases, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The FDA uses “four distinct and successful approaches to making such drugs available as rapidly as possible,” according to its website: Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track.
“Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them,” the FDA says.
S. 2669, which Sens. Hatch and Young introduced on April 16, would instruct the FDA to issue guidance clarifying the qualification parameters for Breakthrough Designation and Accelerated Approval and how they apply to non-opioid or non-addictive pain medications and treatments for substance use disorders, according to a joint statement from the senators.
“Today, we have one option for severe pain: opiates. That is simply unacceptable,” Sen. Hatch said. “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.”
Sen. Young noted that the nation’s opioid epidemic also continues to devastate families in his home state of Indiana. “We must accelerate the development of non-addictive pain medications and treatment,” he said.
Sen. Young added that roughly 785 deaths related to opioid overdoses occurred in Indiana during 2016. “That’s 785 people who didn’t come home to their families,” he said. “This bill represents one step we can take right now to help stop this crisis and save lives.”
U.S. Sens. Michael Bennet (D-CO) and Joe Donnelly (D-IN) signed on as original cosponsors to S. 2669, which has been referred to the U.S. Senate Health, Education, Labor, and Pensions Committee.