Antimicrobial Resistance
What is Antimicrobial Resistance?
Antimicrobial Resistance (AMR) is a natural process that occurs when microorganisms such as bacteria, viruses, fungi and parasites develop the ability to survive against the drugs designed to kill them. That means the resistant germs can continue to grow and spread to other people, both through hospitals and community settings. Unfortunately, the current arsenal of antimicrobial treatments were not developed to treat newly resistant strains and the pipeline of new antimicrobials needed to stem the tide of AMR has been on the decline. Despite an existing research and development pipeline, too few of them target the priority pathogens identified by public health experts. To solve the growing AMR crisis, it is critical to ensure that treatments can keep pace with evolving pathogens and continue to fight infections.
Antimicrobial Resistance A Growing Public Health Threat
Antimicrobial Resistance: A Growing Public Health Threat
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. Having a robust pipeline of medicines to address AMR is a key part of that preparedness. If we fail to address this growing crisis, many modern medical advances that depend on antibiotics — such as routine surgery, cancer therapy and treatment of chronic disease — may be jeopardized.
Along with our government’s commitment to addressing the COVID-19 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.
Download the fact sheet below, or learn more about antimicrobial resistance here.
Antimicrobial Resistance: A Growing Public Health Threat image
AMR
Fact Sheet
Medicines in Development for Antimicrobial Resistance (AMR) Report
Medicines in Development for Antimicrobial Resistance (AMR) Report
Challenges in Researching, Developing and Commercializing New Medicines to AMR
Developing new medicines is a long, complex and risky process. Among antibiotics, this process is fraught by significant risk and can take anywhere from 10 to 20.5 years to develop a single new medicine. In fact, in existing classes of antibiotics in preclinical development, just 1 in 15 will ultimately be approved and reach patients.
Unlike most other medicines, the market for antimicrobials is inherently limited by design. To slow and control continued antimicrobial resistance, public health experts have recommended stewardship programs to ensure that newer medicines are used responsibly, 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 costs in subsequent sales.
Owing to these challenges, many biopharmaceutical research companies have declared bankruptcy in recent years or exited the field. While some federal policies have enhanced the research ecosystem and have provided 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.
Policy Prescriptions: The Path Forward
In the past decade, health policy experts have advanced new policy ideas aimed at incentivizing companies to continue to invest in, or return to, antimicrobial product development. One measure policymakers should consider is the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, which would incentivize the development of antibiotics by:
- Offering "subscription" contracts ranging from $750 million to $3 billion for FDA-approved antibiotics that target critical-need pathogens
- De-linking profits from volume so companies are willing to develop antibiotics even if used sparingly
- Ensuring stewardship to encourage appropriate use of the medicines
Payment reforms addressing misaligned incentives in the inpatient bundled payment system that encourage use of low-cost generics over antibiotics that might be more appropriate for patients in Medicare would also make a meaningful difference.
As we look to the future, we’re also doing our part. That is why we came together to create the AMR Action Fund with a $1 billion industry investment to develop new antimicrobials. PhRMA and our members support 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.
Related Resources
Addressing the mounting threat of antimicrobial resistance
On Thursday, September 26th, the United Nations General Assembly will host a meeting on the growing threat that antimicrobial resistance (AMR) poses to people around the world. This marks an important moment in the fight to address AMR, which the World Health Organization (WHO) has deemed “one of the biggest threats to global health, food security and development today.”
AMR is a natural process that occurs when harmful microorganisms like bacteria, viruses, fungi and parasites develop the ability to survive against medications designed to kill them.
Here is a closer look at the impact of AMR:
- AMR accounts for approximately five million deaths worldwide a year and according to new data in The Lancet, 39 million deaths could be directly attributed to AMR between now and 2050.
- More than 2.8 million Americans contract a drug-resistant infection each year, and those infections result in nearly 50,000 deaths.
- Despite the very real danger that comes with drug-resistant infections, nearly half of U.S. adults are unaware of AMR and its dangers.
What policy challenges do we see with AMR?
Although these drug-resistant superbugs evolve daily, the pipeline to develop new medications has not evolved and has even slowed in recent years. The inherent problem with establishing a robust pipeline for new antimicrobials is, unlike other medicines, the market is limited by design. That is because to slow the process of resistance, new medicines must only be used in a limited set of circumstances and in the most necessary cases, making it challenging for biopharmaceutical companies to successfully develop these much-needed medicines.
This is why federal policymakers from both political parties and experts in the medical community have increasingly vocalized the need to overcome this market failure and address the growing threat of AMR:
Senator Ed Markey (D-Mass.) — “If we do not address antimicrobial resistance, we will face a growing healthcare threat to our country.”
Representative Morgan Griffith (R-Va.) — “As it stands right now, antibiotic-resistant infections can be extremely difficult to treat. AMR is often referred to as the silent pandemic and has become one of the biggest medical concerns today. The pipeline for AMR drugs has slowly been drying up due to various reasons that deserve our attention.”
Thomas Heymann, President and CEO of the Sepsis Alliance — “While drug-resistant superbugs have evolved, our antimicrobials have not. With AMR causing even more sepsis deaths, we are at a pivotal point in the fight against AMR — we can’t afford to wait to develop new medicines to combat superbugs.”
What can be done?
AMR poses a major threat, especially to older adults but also to every person across the globe, regardless of age, gender, race or geographic location. The U.S. has made strides to address this issue, but more is needed to bolster the development pipeline of new medicines to combat superbugs.
The PASTEUR Act has emerged as a beacon of hope. Under the PASTEUR Act, the government would establish a guaranteed market for novel antimicrobial drugs once they’re approved by the FDA. This bill has received bipartisan, bicameral support and is lauded by the scientific community and providers as a vital step in the fight against AMR.
As world leaders and policymakers convene to discuss this critical threat, the time to act is now. With effective policy and global collaboration, we can slow down and eventually reverse the rise of AMR around the world.
Jocelyn Ulrich
Addressing the mounting threat of antimicrobial resistance
AMR Ecosystem
Without a commercially viable antimicrobial market, many small, start-up biotech companies often struggle to find the financing to overcome the pre-clinical stages of development known as the “valley of death,” where many projects are abandoned due to lack of funding. Even among those that surpass this hurdle and make it into clinical testing, many struggle to find financing or broker acquisition by a larger pharmaceutical company in order to bring a drug to market. A unique biopharmaceutical ecosystem has evolved to address these challenges.
AMR ecosystem teaser
Resource
ICYMI: New report demonstrates growing global impact of antimicrobial resistance
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.
Jocelyn Ulrich
ICYMI: New report demonstrates growing global impact of antimicrobial resistance
Fact Sheet on Challenges with AMR
The fundamental problem with developing new medicines to target antimicrobial resistance is, unlike most other medicines, the market is inherently limited by design. In order 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 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.
Fact Sheet
AMR Action Fund Launch: Bridging The Gap: New Collaborations to Drive Antimicrobial Innovation
AMR Action Fund Launch: Bridging The Gap: New Collaborations to Drive Antimicrobial Innovation