Championing a Sustainable Pipeline for Antibiotics

Scientists around the world agree that global innovation is needed to address the shortage of effective antibiotics. We fund and support much-needed research and development, but new policies are needed to promote a sustainable, robust antibiotics pipeline and a marketplace that rewards innovation.

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Summary

People with cystic fibrosis face a heightened life-long risk of infections because of the thick, sticky mucus in their lungs. Routine use of antibiotics in CF care is medically necessary. However, too many people with cystic fibrosis find themselves battling difficult-to-treat infections for which existing antibiotics are not effective or have severe side effects, such as hearing loss.
We remain committed to significant investments in innovative therapies and research to address chronic, difficult-to-treat infections and antibiotic resistance in CF. However, we also need to ensure new infection treatments that stem from this research make it into the hands of patients.
It is vital to find new ways to pay for antibiotics and reward companies that bring much-needed new antibiotics to market. We need comprehensive action from Congress and the administration to enact policies that ensure availability and access to antibiotics that work — both now and in the future.

Each year, 2.8 million Americans get a serious infection caused by antibiotic-resistant bacteria. The U.S. Centers for Disease Control estimates that 2.8 million Americans get an antibiotic-resistant infection every year, resulting in 35,000 deaths. Globally, the number of antibiotic-resistant infections was 1.27 million in 2019, which led the World Health Organization to designate antibiotic resistance as a top global health threat. According to a study in The Lancet, antimicrobial resistance killed more people in 2019 than HIV/AIDS and malaria.

The economic toll of antimicrobial resistance (AMR) is also staggering — six of the worst resistant bacteria increase U.S. health care costs by $4.6 billion annually. Notably, AMR increases a patient’s risk for developing sepsis, the body’s overwhelming response to infection. Sepsis already affects 1.7 million patients in the U.S. and costs Medicare more than $41 billion in sepsis-related inpatient and skilled nursing facility admission costs each year. As resistance worsens, the financial and human costs of sepsis will only increase. Antibiotic resistance is a public health crisis that we can no longer ignore, and new solutions are needed now. The longer we go without policies that provide incentives for innovation and development, the weaker the pipeline of new antibiotics will become, threatening our chances of having effective antibiotic treatments in the future for people with CF and all Americans.

Impact of Antibiotic Resistance on People with CF

People with CF face a heightened life-long risk of infections because of the thick, sticky mucus in their lungs. Routine use of antibiotics in CF care is medically necessary. However, too many people with cystic fibrosis find themselves battling difficult-to-treat infections with no effective treatments available.

Antibiotics are unique in that their effectiveness can weaken over time. The need to use these treatments sparingly — whenever medically appropriate — makes it difficult for manufacturers of novel antibiotics to receive an adequate return on their investment. As a result, many manufacturers decide against the financial risk of developing new antibiotic drugs, leaving the antibiotics pipeline barren.

Difficult-to-treat respiratory infections are a hallmark of cystic fibrosis. Even at very young ages, more than 60% of people with CF test positive for at least one bacteria that could make them ill. This rate increases to more than 80% as they grow older, signaling the continued threat of multi-drug-resistant infections to the CF community.

With few new antibiotics in the drug development pipeline, people with CF are left with significant unmet antibiotic treatment needs. We anticipate this problem will grow as antibiotic-resistant infections continue to become more prevalent.

Our Work to Strengthen the Antibiotics Market

Because of the unique role antibiotics play in the care regimen of people living with CF, the Foundation is committed to doing its part to address significant unmet antibiotic treatment needs. From 2018 to 2023, the CF Foundation invested more than $170 million to fund the research and development of new treatments for infections as part of the Infection Research Initiative, a sweeping effort to advance infection research. We remain committed to significant investments in innovative therapies and research to address chronic, difficult-to-treat infections and antibiotic resistance in CF.

Research investment alone will not solve this problem and that’s where policy solutions come in. The Foundation is in a unique position to inject patient perspectives into these conversations. We share stories of patients who experience the real-life consequences of antibiotic-resistant infections. We also know that advocacy is necessary in this work, and a coalition of voices is needed to push for policy solutions that foster a robust research and development pipeline.

Our Policy Position on Antibiotics Development

It is vital to find new ways to pay for antibiotics and incentivize companies that bring much-needed new antibiotics into the hands of patients. We need comprehensive action from Congress and the administration to enact policies that ensure access to effective antibiotics — both now and in the future. The CF Foundation supports legislation that will:

Provide robust funding for domestic and global antimicrobial programs
Establish novel payment models to incentivize the development of new, effective antibiotics
Strengthen antibiotic stewardship programs

Read more about our work to bolster the antibiotic development pipeline on cff.org.

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