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# Bill to Expedite Opioid Alternative Approval
- URL: https://www.fdaweb.com/bill-to-expedite-opioid-alternative-approval/
- Published: 2018-04-17T12:00:00.000Z
- Updated: 2026-09-14T23:59:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141239

A bipartisan group of four senators has introduced legislation they say will help bring non-opioid or non-addictive pain medications and treatments for substance abuse disorders to patients more quickly. The bill was introduced by Sens. **Orrin Hatch** (R-UT), **Michael Bennet** (D-CO), **Joe Donnelly** (D-IN) and **Todd Young** (R-IN), and instructs 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 abuse disorders.

In a [statement](https://www.hatch.senate.gov/public/index.cfm/2018/4/hatch-bennet-donnelly-and-young-introduce-bill-to-expedite-approval-of-opioid-alternatives?ref=fdaweb.com), the senators say that the 2012 Advancing Breakthrough Therapies for Patients Act created a safe pathway for FDA to expedite approval for treatments that show dramatic responses in early development. And, it says, 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,” the statement says, “there is currently a lack of clarity surrounding the approval process for alternatives to opioids and treatments for addiction. The bipartisan bill introduced today (4/16) clarifies this process to bring novel, non-addictive drugs and treatments to market more quickly.”