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Health organizations urge Senate leaders to pass PATH Act
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Forty-two U.S. health organizations have co-signed a joint letter to Senate leaders calling for swift approval of the Promise for Antibiotics and Therapeutics for Health, or PATH, Act.
Orrin G. Hatch
Michael F. Bennet
Since the bill passed in the House last year, the “alarming” emergence of the MCR-1 colistin resistance mechanism in Chinese and American patients has increased the need for resistance-focused legislation, the organizations wrote. The drug approval pathway proposed in the act would facilitate the development of novel treatments for resistant illnesses, they said, and deliver them to affected patients.
“Antibiotics are fundamental to modern medicine, essential for protecting vulnerable patients receiving chemotherapy or being treated in intensive care units,” the organizations wrote in the letter. “But the proliferation of antibiotic-resistant bacteria — a result of decades of overuse combined with a lack of new drug development and innovation — threatens to bring us to a ‘post-antibiotic’ world in which even the most simple surgical procedure could have deadly consequences.”
The PATH Act, or S. 185, seeks to establish a new limited population pathway for antibacterial drugs to treat serious or life-threatening infections where there is an unmet medical need for appropriate treatments. It was introduced in December 2014 by Sens. Michael F. Bennet, D-Colo., and Orrin G. Hatch, R-Utah.
According to the letter, the development of MCR-1 and the prevalence of other resistance infections requires a comprehensive response, which will include optimizing antibiotic use and prioritizing new drug discovery and development. However, few of the drugs in the pipeline will address many serious infections, and various economic and regulatory issues are dissuading pharmaceutical companies from this area of research. These issues, they wrote, would be mitigated by legislation included in the act.
The letter referenced commitments by international partners, such as WHO and the Group of Seven (G7), to the issue, and noted an upcoming U.N. General Assembly that will be addressing the topic. Further, the organizations commended Congress’ passage of the Generating Antibiotics Incentives Now (GAIN) Act in 2012, and the House’s approval of the 21st Century Cures Act in 2015.
“There are glimmers of hope,” they wrote. “However, they are insufficient to ensure that patients have access to the drugs they need most — drugs to treat serious and life-threatening infections for which there are few or no other options. The PATH Act would be an important complement to GAIN by facilitating development of these vital drugs.”
The letter was addressed to Senate Majority Leader Mitch McConnell, R-Ky., Minority Leader Harry Reid, D-Nev., Lamar Alexander, R-Tenn., and Patty Murray, D-Wash. Co-signing organizations include: the Infectious Diseases Society of America, the American Society for Microbiology, the Antimicrobials Working Group, the Pediatric Infectious Diseases Society, and the Association for Professionals in Infection Control and Epidemiology. – by Dave Muoio