New research published in The Lancet shows for the first time the global impact of antimicrobial resistance (AMR), which poses an increasingly serious threat to human health around the world. The study found AMR is directly associated with at least 1.27 million deaths per year, making AMR a leading cause of death globally, higher than HIV/AIDS and malaria. In the United States alone, the CDC estimates AMR affects at least 3 million Americans and results in 48,000 U.S. deaths annually. Today’s report also builds upon a body of evidence further confirming the growing fear about the link between COVID-19 and increasing levels of AMR. Not only have these infections become more common as a result of the pandemic but they have also become more deadly.
PhRMA and our members are committed to bolstering pandemic preparedness and health care resiliency to make sure our country and American patients are stronger, healthier and better prepared for the next public health emergency. Further, having a robust pipeline of medicines to address AMR is a key part of that preparedness. Last year, we reported an R&D pipeline of nearly 90 medicines in development to address AMR. That report confirmed what has been warned by other experts — there are too few antimicrobial medicines in development targeting the priority pathogens discussed in The Lancet report to meet current and anticipated needs.
The fundamental problem with developing new medicines to target antimicrobial resistance is, unlike most other medicines, the market is inherently limited by design. To slow and control continued antimicrobial resistance, newer medicines are frequently used only in a limited set of circumstances and in only the most necessary cases. This makes it challenging for biopharmaceutical research companies to recoup research and development (R&D) costs in subsequent sales. Antibiotic stewardship programs are designed to limit the use of new antibiotics specifically for this reason and thus limit the commercial viability of new antimicrobials.
While recent policy changes have enhanced the research ecosystem and have sought to provide support and incentives for researchers to develop new antimicrobial medicines, additional policy reforms are still needed to create a more sustainable environment for antimicrobial R&D and commercialization and ensure a robust pipeline for future treatments. The PASTEUR Act is a policy that would help achieve this goal by creating a novel payment mechanism to ensure a return on investment for high need antimicrobials. Payment reform that would address reimbursement barriers in the inpatient bundled payment system in Medicare would also make a meaningful difference. It is critical that policymakers advance these policies because if we fail to address the crisis, many modern medical advances that depend on antibiotics — such as routine surgery, cancer therapy and treatment of chronic disease — may be jeopardized.
As we look to the future, we urge policymakers to examine the growing threat of AMR and advance solutions to this significant and growing public health threat. Along with our government’s commitment to addressing the current pandemic, we can be prepared for the next public health emergency if we all work together to ensure a sustainable pipeline for new antimicrobials for this crisis and those in years to come.
To read a fact sheet further exploring the challenges of AMR, click here.