By: Gregory Arcuri
The World Health Organization (WHO) has identified
antimicrobial resistance (AMR) as “one of the greatest health challenges of our time.” According to the Center for Disease Control and Prevention (CDC) drug-resistant infections, which are life-threatening strains of typically treatable diseases, are responsible for $4.6 billion
in treatment costs and at least 35,000 deaths in the United States each year. The dangers associated with AMR are particularly severe among immune-compromised communities, but healthy individuals who undergo even routine medical procedures are also at risk of contracting them in healthcare settings.
Despite the pressing societal need to address the threat of AMR, the development and manufacturing of new antibiotics to fight these super-bugs face unique challenges within the U.S. biopharmaceutical innovation ecosystem. To overcome these challenges, the federal government must play a role in overcoming market barriers to innovation in this critical-need sector of public health.
Antibiotic drugs are potent, often life-saving treatments that are the primary weapon against infections which are beyond the power of other medicines to treat. However, they must be administered and prescribed responsibly. Excessive prescription of antibiotics may accelerate the emergence of pathogens which are resistant to these treatments, exacerbating the problem they are meant to solve.
This presents an ethical and business challenge for firms looking to develop, manufacture, and market these drugs, since profits in the drug industry are often tied to volume of sales. In theory, an antibiotic that sells well will reduce its own effectiveness over time and worsen the issue of AMR. These drugs are also often used as last-resort treatments when other remedies have failed.
Biopharmaceutical and venture capital firms, therefore, lack an incentive to invest millions of dollars in the development of a product they cannot feasibly make a return on. However, the availability of these drugs as a treatment option and their continued development are important for the care of critically or chronically ill patients.
The Policy Remedies
Recent policy proposals to address AMR have drawn significant attention. Key among these has been the PASTEUR Act
, which seeks—among other things—to establish a federal “subscription model” for critical-need antibiotics meant to decouple profits from volume of sales.
The most recent version
of the bill would authorize $6 billion for the government to enter into contracts with pharmaceutical manufacturing firms for supplying novel and effective antibiotics, providing a guaranteed return-on-investment for the development of drugs identified by the U.S. government as “critical-need.” While proponents of the PASTEUR Act acknowledge
it is not a cure-all for the problem of AMR, they assert that the bill would be essential for clearing the primary barrier to innovation in antibiotics.
The bill enjoys significant bipartisan support
among lawmakers in both chambers
and among public health officials, but efforts to include it in the National Defense Authorization Act for Fiscal Year 2023 were unsuccessful. Critics of the measure argued
that the bill does not address the root cause of lagging innovation in antibiotic drugs, which—they say
—is a result of a flawed FDA-approval process that does not require candidate drugs to prove their effectiveness or superiority over existing drugs.
However, the realities of treating patients with antibiotics—advocates argue
—make conducting extensive clinical trials both impractical and, in some cases, unethical. Since many antibiotics are administered to critically ill patients as a last-resort, finding suitable and willing trial participants for a candidate drug is a serious challenge. Furthermore, testing a new drug against a placebo among chronically sick individuals could endanger their lives.
To ensure that the antibiotic development process yields effective medicines, advancements in diagnostic technologies could increase the available pool of trial-eligible patients on which these treatments could be ethically tested.
The United States is the recognized world leader
in biopharmaceutical innovation. To combat the COVID-19 pandemic, U.S. industry led the way in developing the most effective vaccines and therapeutics in record time. However, those commercial successes were facilitated by extensive and long-term cross-sector collaboration, with stakeholders in academia and the federal government all playing a role
in the breakthroughs that would save countless lives from the coronavirus.
Operation Warp Speed, the federal effort to accelerate the development of COVID-19 vaccines, is a clear and successful example
of public-sector stakeholders across government providing guidance and targeted investments to overcome market barriers to innovation and at-scale manufacturing of critical biotech.
The global public health community, the pharmaceutical industry, and U.S. lawmakers understand that threat of AMR is real and growing. However, before AMR evolves into a COVID-scale crisis, lawmakers have an opportunity to play a more active role in ensuring our biotechnology industry can proactively address the AMR threat.
Beyond the public health implications, maintaining U.S. leadership in antibiotic manufacturing and R&D will further solidify the United States’ status as the premier global marketplace for critical healthcare solutions. Continued U.S. economic competitiveness is predicated upon
a strong biotechnology industrial base. PASTEUR is a key part of a U.S. strategy to grow the nation’s biotechnology and pharmaceutical innovation ecosystem, strengthen its health security, and maintain its competitive leadership. However, more investment across the U.S. biotech innovation ecosystem is needed.
For example, antibiotic drugs are only one solution for combatting drug-resistant infections. Innovations in devices and healthcare practices that increase diagnostic speed and reduce transmission of superbugs are other important parts of the AMR puzzle which PASTEUR does not address. However, advancements in these solutions face similar hurdles which require unique policy responses to overcome.
WHO data estimates
that drug-resistant infections are projected to kill 10 million people around the world annually by 2050. It is time for Congress and the White House to make the necessary investments in innovation to counter this intensifying threat.
Gregory Arcuri is a research assistant with the Renewing American Innovation Project at the Center for Strategic and International Studies in Washington, DC.
The Perspectives on Innovation Blog is produced by the Renewing American Innovation Project at the Center for Strategic and International Studies (CSIS), a private, tax-exempt institution focusing on international public policy issues. Its research is nonpartisan and nonproprietary. CSIS does not take specific policy positions. Accordingly, all views, positions, and conclusions expressed in this publication should be understood to be solely those of the author(s).