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 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.
  • 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.
  • Finding new ways to pay for antibiotics to rewarding companies that bring much-needed new antibiotics to market are vital. 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.

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 700,000, causing the World Health Organization to designate antibiotic resistance as a top global public-health threat. According to a recent 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. The financial challenges associated with bringing a new antibiotic to market and keeping it there are great. 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

In 2018, the CF Foundation dedicated $100 million through 2024 to an Infection Research Initiative as part of a sweeping effort to advance infection research. The Foundation already has committed more than $109 million to the initiative, and we will continue to fund 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. To this end, we are working to strengthen the antibiotics market through a variety of actions:

  • In July 2020, CF Foundation President and CEO, Michael Boyle, MD, virtually joined healthcare leaders on an expert panel to discuss the need for novel antibiotics as superbugs and antibiotic resistance continue to be a global health concern.
  • In February 2021, we joined S-FAR in a letter to President Biden urging him to make antimicrobial resistance a priority for the G7.
  • In June 2021 we affirmed our support of the introduction of the PASTEUR Act.
  • In August 2021, CF Foundation Pres ident and CEO, Michael Boyle, MD, spoke about the issue of antibiotic resistance at the World Orphan Drug Congress.
  • Foundation leadership provided the patient perspective on the importance of combatting antibiotic resistance. Listen to the two podcasts here and here

Our Policy Priorities

Finding new ways to pay for antibiotics to rewarding companies that bring much-needed new antibiotics to market are vital. 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 and will lead to a more robust pipeline of products. Key components include:

  • Funding for innovative therapies that would delink financial value from use
  • Post-market incentives that ensure innovative therapies stay on the market
  • Stewardship program funding that would allow these therapies to be effective for longer

Ask your member of Congress to support the PASTEUR Act today

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Topics
About the CF Foundation | Antibiotics | Infections | Public Policy
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The Silent Pandemic - Addressing Sustainable Solutions for the Antibiotics Marketplace Download (PDF)
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