Washington, D.C. — Colorado U.S. Senator Michael Bennet, with Senators Orrin Hatch (R-UT), Joe Donnelly (D-IN), and Todd Young (R-IN), today 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, Bennet authored and secured passage of the Advancing Breakthrough Therapies for Patients Act, creating a safe pathway for the U.S. Food and Drug Administration (FDA) to expedite approval for treatments that show dramatic responses in early development. The Accelerated Approval Program also 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 would clarify this process to bring novel, non-addictive drugs and treatments to market more quickly.
The Advancing Innovation in Alternative Pain and Addiction Therapies Act would instruct 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.