Offering Market Incentives to Address Antimicrobial Resistance

Earlier this year, the Pew Trusts released a report that showed there were only 43 new antibiotics in development. Typically it takes 10 to 15 years from development to approval for antibiotics, but it only takes 2 years to develop bacterial resistance to new antibiotics.

This is compounded by the fact more than 2.8 million antibiotic-resistant infections occur in the United States and at least 35,000 people die as a result according to the US Centers for Disease Control and Prevention’s (CDC) Antibiotic Resistance Threats in the United States report.

While there is certainly a need for new therapies, there are significant barriers for development. With the process taking several years, many smaller companies end up dropping out of development. In addition, the market for reimbursement is low for antibiotics and further disincentivizes pharmaceutical companies from developing them.

The US federal government is looking to create incentives to encourage companies to develop new antibiotics. The US National Action Plan for Combating Antibiotic-Resistant Bacteria directed federal agencies to accelerate a response to antibiotic resistance and take action to expand the ability of our health care system to prevent, identify, and respond to the infection pandemic threat posed by antimicrobial resistance. Part of this plan was to increase and incentivize development of innovative antimicrobial drugs to treat resistant infections.

The Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act, is a bipartisan, bicameral piece of legislation aimed to incentivize innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability when needed. Initially introduced in Congress by U.S. Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) in September of last year, Bennet and Young along with and Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.) reintroduced the bill in June.

The prospective bill if passed, would do the following:

• Establish a subscription model to encourage innovative antimicrobial drug development aimed at treating drug-resistant infections. This model will be fully delinked, meaning that participating developers would not receive income, as a part of their subscription payments, based on volume or quantity of sales.
• Subscription contracts would contain terms and conditions including product availability to individuals on a government health insurance plan, supporting appropriate use, and completion of postmarketing studies. These contracts could be valuated between $750 million and $3 billion.
• Build on existing frameworks to improve usage of the CDC National Healthcare Safety Network, the Emerging Infections Program, and other programs to collect and report on antibiotic use and resistance data.
• Include transition measures such as smaller subscription contracts to support novel antimicrobial drug developers that need a financial lifeline.

Contagion spoke with Wes Kim, PhD, senior officer Antibiotic Resistance Project, Pew Trusts who provided further insights about the Pasteur Act, discussed the economic pull incentives to stimulate antibiotic development, and the role COVID-19 played in the antibiotic market.