The limited-population antibacterial drug (LPAD) pathway authorized in the 21st Century Cures Act will help patients with resistant infections by providing a unique mechanism for the Food and Drug Administration to review and approve new antibiotics specifically for use in patients with unmet medical needs.
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In December, President Barack Obama signed into law the 21st Century Cures Act, which includes several provisions that will play an important role in combating the growing global threat of antibiotic resistance. The wide-ranging, bipartisan law, supported by an overwhelming majority in both houses of Congress, tackles the public health challenge of antibiotic resistance from several angles. Most notably, it creates a new, targeted approval pathway that will help spur innovation of new antibiotics. It also includes measures to help preserve the effectiveness of existing antibiotics, and it addresses the need to better monitor the threat of resistant bacteria as it evolves.
The majority of infectious disease doctors have treated patients with infections that did not respond to any available antibiotic. At the same time, there are not enough antibiotics in development with the potential to treat the most dangerous pathogens.
The limited-population antibacterial drug (LPAD) pathway authorized in the 21st Century Cures Act will help patients with resistant infections by providing a unique mechanism for the Food and Drug Administration to review and approve new antibiotics specifically for use in patients with unmet medical needs. This process will make the development of the most needed antibiotics more feasible while maintaining FDA’s standards for safety and effectiveness. The Pew Charitable Trusts is part of a broad group of stakeholders that have long supported this approach, which will help bring new medicines to patients who have few or no treatment options and will ultimately save lives.
The law also improves data that health care providers rely upon when choosing an antibiotic. Known as “breakpoints,” these data are a guide to which bacteria can be treated with which drug. The Cures Act will allow the FDA to update breakpoint data in a more timely fashion. This will reduce inappropriate antibiotic use that can lead to resistance.
The law also requires the Department of Health and Human Services to monitor the use of all approved antibiotics and report annually on antibiotic resistance trends at the national and regional level. It also encourages more comprehensive surveillance of antibiotic-resistant bacteria via increased reporting into the Centers for Disease Control and Prevention’s National Healthcare Safety Network. Reporting into the network and other national databases is critical to tracking antibiotic use and resistance trends.
Pew applauds policymakers for addressing and prioritizing the threat of antibiotic resistance in this new legislation and is especially thankful to Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) and Representatives John Shimkus (R-IL) and Gene Green (D-TX) for their leadership on this issue. We look forward to continued work with government officials, public health advocates, health care providers, industry partners, and the many other stakeholders committed to fighting antibiotic resistance.
Kathy Talkington directs The Pew Charitable Trusts’ work on antibiotics.
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