Championing a Sustainable Pipeline for Antibiotics

Scientists around the world agree that global innovation is needed to address the shortage of effective antibiotics. Our Infection Research Initiative supports 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.
  • Through our Infection Research Initiative, we are funding any science that we believe holds real promise to address infections. 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 acquire a serious infection caused by antibiotic-resistant bacteria. As a result, 35,000 Americans die. Globally, that number rises to 1.27 million, which led to the World Health Organization designating antibiotic resistance as a top global public health threat. According to a study in The Lancetantimicrobial resistance killed more people in 2019 than HIV/AIDS and malaria.

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% in older ages, signaling the continued threat of multi-drug resistant infections to the CF community.

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.

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.

While this issue is not ours alone to solve, the CF Foundation along with the CF community is bringing urgently needed attention to the threat of antibiotic-resistant infections and encouraging lawmakers to invest in solutions for the vital antibiotics market.

A Sustainable Pipeline Matters to 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 for which existing antibiotics are not effective.

Because the effectiveness of antibiotics can weaken over time, a robust antibiotics development pipeline is a necessary part of ensuring continued access to products that work.

With few new antibiotics in the drug development pipeline, patients are left with significant unmet antibiotic treatment needs — and we anticipate this problem will grow as antibiotic-resistant infections become more prevalent. There are great financial challenges associated with bringing a new antibiotic to market and keeping it there. Antibiotics rarely command a high price, and many antibiotic developers are struggling just to cover the costs of manufacturing their products.

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 our part to address significant unmet antibiotic treatment needs. In 2018, the CF Foundation dedicated $100 million through 2023 to an Infection Research Initiative as part of a sweeping effort to advance infection research. The Foundation already has committed $143 million to the initiative, surpassing our initiative investment nearly two years ahead of schedule. Though we reached the initial investment milestone, we are continuing to fund any science that we believe holds real promise to address infections.

Research investment alone will not solve this problem and that’s where policy solutions come in. We need to ensure new antibiotics get into the hands of patients. The Foundation is in a unique position to inject the patient perspective 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 Priorities

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 access to antibiotics that work — both now and in the future. The PASTEUR Act, a bipartisan, bicameral proposal, will create a new post-market incentive structure that rewards companies who pursue and develop innovative new antibiotics and antifungals. This will lead to a more robust pipeline of products that will help us battle antibiotic resistance. The PASTEUR Act will:

  • Establish a contract model to incentivize the development of new, effective antibiotics
  • Ensure only innovative antibiotics qualify for the program
  • Strengthen antibiotic stewardship programs
  • Only pay for products that are FDA approved
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Topics
About the CF Foundation | Antibiotics | Infections | Public Policy
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