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# Senators Will Try to Move Antibiotic Approval Bill
- URL: https://www.fdaweb.com/senators-will-try-to-move-antibiotic-approval-bill/
- Published: 2016-06-02T12:00:00.000Z
- Updated: 2026-09-14T21:07:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135819

Sens. **Michael Bennet** (D-CO) and **Orrin Hatch** R-UT) say they will attach their bill to create a new antibiotic drug approval pathway as an amendment to the National Defense Authorization Act for Fiscal Year 2017\. Their Promise for Antibiotics and Therapeutics for Health ([PATH](https://www.bennet.senate.gov/?p=release&id=3229&ref=fdaweb.com)) act would permit FDA to approve an antibacterial drug for a limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need.

It also includes provisions to guide appropriate use of antibiotics approved under the pathway, such as labeling and promotional material requirements. And it calls for implementation of antibiotic stewardship programs and more robust surveillance of bacterial resistance through the Center for Disease Control’s National Healthcare Safety Network and other national tracking systems.

The two introduced PATH as a standalone bill early in 2015\. It was approved by the Senate HELP Committee and has not gone any further. Bennet and Hatch say they are attempting to move the legislation ahead now in response to discovery of a bacteria resistant to colistin, an antibiotic of last resort.

“Superbugs are a growing threat to our public health and national security,” Bennet says. “The colistin-resistant bacteria found in a patient in Pennsylvania underscores how vulnerable we are to a growing number of superbugs. Yet, research has lagged to the point where a truly novel antibiotic hasn’t been discovered in more than 30 years. This bipartisan amendment would encourage researchers to find new antibiotics to treat otherwise unstoppable infections before it’s too late.”