Is the PASTEUR Act the Correct Way to Tackle Antibiotic Resistance?

The World Health Organization (WHO) classifies the rise in microorganism resistance to existing medications as a matter of global concern that affects the individuals’ quality of life regardless of economic status or geographical location.¹ In 2019 alone, 6.22 million deaths were considered associated with or directly as a result of antimicrobial resistance (AMR).² In response to such a crisis, WHO proposed that public health stakeholders worldwide invest efforts in 40 priority actions that can mitigate the rising AMR, including the development of better policies and legislation on health care financing and novel antibiotics development.³

The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act is a financial support program for researchers and pharmaceutical firms to develop novel antibiotics and ensure their fair use and distribution to patients.⁴ It was introduced in 2019 and proposed a stimulus of up to $3 billion over 5 to 10 years for beneficiary entities who can focus on developing potent drugs to combat AMR over higher-output, less essential medications just to keep business afloat.5 The program is based on a subscription model in which the US Department of Health and Human Services would pay pharmaceutical companies to provide FDA-approved antibiotic medications at reduced or no cost to patients on federal insurance plans.^4,6 Through CDC grant supplementation, PASTEUR-covered medications would also reach hospitals around the country that would normally not have funds to support an institutional antibiotic stewardship program.⁶ Although the program was introduced with great enthusiasm, several stakeholders argued that PASTEUR would not effectively combat the AMR crisis but exacerbate it.

In February 2024, Doctors Without Borders (MSF) released a 16-page document outlining several concerns with the PASTEUR legislation.⁷ They argued that the program does not sufficiently incentivize companies, which must resume investing in higher-selling medications and rising prices of antibiotics to maintain business position. Additionally, they highlight issues of equity because Americans without federal insurance coverage and noncitizen patients would not have access to PASTEUR-subsidized antibiotics.⁶

Another point of concern is the cap on partner companies for selling nonantibiotic medication, which is set at a maximum of 5 times the subscription amount. MSF believes that such a cap might hinder availability of medications that, although not targeting AMR, are still needed by patients. Supporters of the act, however, believe that PASTEUR includes sufficient regulations to prioritize truly necessary antibiotic medications and that the effort to disconnect sales from revenue alone is enough to ensure drug stewardship.⁶

Other critics come from a coalition of public health stakeholders who wrote to Congress in 2022, arguing that PASTEUR does not address an important determinant of AMR: the ease with which the FDA approves new antibiotics that are just as potent as predecessors already on the market.6 However, such novel medications often improve treatment in other ways, such as through a lower required dose or more distanced administration time. Some critics highlight that new antibiotics are not tested on groups that accurately reflect the most affected populations, such as older adults or patients resistant to antibiotics. Yet such a request raises a serious ethical dilemma because improving the health of very ill patients should come first and not be a matter of experimentation.^5-7

Despite ongoing debate about the potential success of the PASTEUR legislation, efforts to pass the bill continue. It has been reintroduced with a nearly 50% reduction of the initial budget to make it more appealing to Congress.^6,7 Although its passage remains uncertain, suggestions about potential improvements are still being made, such as the establishment of an independent regulatory board to oversee which priority pathogens the PASTEUR Act should target.⁶

REFERENCES

1. Antimicrobial resistance. World Health Organization. November 21, 2023. Accessed October 25, 2024. https://www.who.int/news-room/fact-sheets/detail/antimicrobialresistance

2. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022;399(10325):629-655. doi:10.1016/S0140-6736(21)02724-0

3. Global research agenda for antimicrobial resistance in human health. World Health Organization. June 22, 2023. Accessed October 25, 2024. https://www.who.int/publications/m/item/global-research-agenda-forantimicrobial-resistance-in-human-health

4. The PASTEUR Act, HR 8920, 116th Cong (2019). Accessed October 25, 2024. https://www.congress.gov/bill/116thcongress/house-bill/8920

5. Madden J. Putting the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act under the microscope. Revive. September 27, 2023. Accessed October 25, 2024. https://revive.gardp.org/putting-thepioneering-antimicrobial-subscriptions-to-end-upsurgingresistance-pasteur-act-under-the-microscope/

6. Dall C. For PASTEUR Act advocates, the finish line is in sight for antibiotic development aid. University of Minnesota. December 6, 2022. Accessed October 25, 2024. https://www.cidrap.umn.edu/antimicrobial-stewardship/pasteur-actadvocates-finish-line-sight-antibiotic-development-aid

7. The PASTEUR Act is not the way for the US government to address antimicrobial resistance. ACCESS Campaign. February 22, 2024. Accessed October 25, 2024. https://www.msfaccess.org/pasteur-act-not-way-us-government-addressantimicrobial-resistance