Earlier this fall, the United Nations General Assembly met to declare a commitment to addressing the public health crisis of antimicrobial resistance. World leaders recognized that nations must act quickly and aggressively to combat drug-resistance and spur antibiotic research and development. The U.S. Senate can make an immediate and important contribution to this effort by passing the bipartisan Promise for Antibiotics and Therapeutics for Health (PATH) Act.
The stakes are high because antibiotic-resistant bacteria claim new victims every day. More than 10 million deaths are expected annually by 2050 due to superbugs, according to the Review on Antimicrobial Resistance, Tackling Drug-Resistant Infections Globally, led by former United Kingdom Treasury Secretary and international economist Lord Jim O’Neill. Our increasingly global community, where infectious diseases readily traverse borders, has been ill-prepared to fight. The recent UN General Assembly action can help change our course.
Within the United States, the Administration and Congress have taken steps to mitigate antibiotic resistance, most notably by passing the Generating Antibiotic Incentives Now (GAIN) Act in 2012, and launching a National Action Plan that was ultimately backed by $380 million in new Fiscal Year 2016 funding. However, public health authorities and individual experts have made clear that more needs to be done. For one, policymakers must address both the regulatory and economic impediments to research and development for new antibiotics.
One specific challenge is populating clinical trials for the most desperately needed new antibiotics. Serious gram-negative infections generally occur in a relatively small number of individuals, which makes it difficult to secure the numbers necessary to fill a traditional large-scale clinical trial. The PATH Act, approved in committee last April as one in a series of bills that are part of a Senate Biomedical Innovations package, would establish a new limited population approval pathway at the FDA for antibiotics that treat often life-threatening infections for which there exists an unmet medical need. For these drugs, the pathway would allow smaller and more efficient clinical trials as well as include safeguards to guide their appropriate use. A similar version of the bill was included in the House-passed 21st Century Cures Act last year. The concept was also endorsed by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. Despite bipartisan support on Capitol Hill, little to no cost, and broad-based stakeholder agreement that the approach would save lives, the bill has been held from a vote of the full Senate for months with hopes that it can be included in the chamber’s final version of the 21st Century Cures Act.
Infectious diseases physicians and scientists know that antimicrobial resistance must be treated with a sense of urgency. It takes several years to develop new antibiotics, and many of the clinical trials cannot be done until the PATH Act is approved. With each day that passes, additional patients die waiting for new antibiotics. Congressional approval of the PATH Act prior to adjourning for the year would demonstrate recognition that lives are on the line and that our nation is capable of exercising leadership to address the crisis.
William G. Powderly, MD, is president of Infectious Diseases Society of America.
The views expressed by authors are their own and not the views of The Hill.