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.
Data shows the COVID-19 pandemic has been exacerbating AMR. As more patients are hospitalized due to severe COVID-19 infections, often due to worsening respiratory symptoms requiring ventilation, an increasing number of patients have been acquiring secondary bacterial infections that require treatment with antibiotics — thereby worsening current levels of resistance.2
Analysis found about quarter of hospitalized COVID-19 patients had a secondary infection. Among these patients, greater than 25% were co-infected with staph and more than half of those staph infections were antibiotic-resistant infections known as MRSA.3 Centers for Disease Control and Prevention research also confirms that cases of resistant, hospital-acquired secondary infections are greater than pre-pandemic levels.4 To make matters worse, not only have resistant infections become more common, but also they have become more deadly.
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 offer “subscription” contracts to manufacturers to provide access to antimicrobial products for patients covered under federal programs.
The subscription would de-link payment from volume for all U.S. government payers, with contracts offered ranging from $750 million to $3 billion based on consideration of certain characteristics of the drug. The intent of the policy is to incentivize companies to develop antimicrobial medicines for infections for which there is unmet medical need, anticipated clinical need, or drug resistance.
Importantly, the PASTEUR Act also includes provisions to ensure appropriate stewardship by requiring companies to develop communications strategies for appropriate use of their drug, as well as submitting a plan for registering the drug in countries where unmet medical need exists and ensuring a reliable supply chain. 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, 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.
(1) PhRMA. Medicines in Development for Antimicrobial Resistance. April 2021. https://phrma.org/resource-center/Topics/Medicines-in-Development/Medicines-in-Development-for-Antimicrobial-Resistance-2021-Report
(3) Shafran, N., Shafran, I., Ben-Zvi, H. et al. Secondary bacterial infection in COVID-19 patients is a stronger predictor for death compared to influenza patients. Sci Rep 11, 12703 (2021). https://doi.org/10.1038/s41598-021-92220-0
(4) Weiner-Lastinger, L., Pattabiraman, V., Konnor, R., Patel, P., Wong, E., Xu, S., . . . Dudeck, M. (2022). The impact of coronavirus disease 2019 (COVID-19) on healthcare-associated infections in 2020: A summary of data reported to the National Healthcare Safety Network. Infection Control & Hospital Epidemiology, 43(1), 12-25. doi:10.1017/ice.2021.362
Updated March 2022