Policies need to address the growing threat of antimicrobial resistance

Today, the House Energy & Commerce Subcommittee on Oversight and Investigations will be holding a hearing on the growing public health threat of antimicrobial resistance (AMR). AMR occurs when microorganisms such as bacteria, viruses, fungi and parasites develop the ability to survive against the drugs designed to kill them. Recognized by the World Health Organization (WHO) as “one of the biggest threats to global health, food security and development today,” AMR is a growing crisis that has resulted in nearly 50,000 U.S. deaths each year and 1.27 million globally on an annual basis – higher than HIV/AIDS and malaria. Without new products to address the problem, AMR could take 10 million lives yearly by 2050.  

Recent news reports shed light on how much of a growing problem AMR is. Just in the last month, the Centers for Disease Control & Prevention reported that cases of Candida auris, a fungus considered an urgent AMR threat, were increasing at an alarming rate across U.S. health care facilities — in which a concerning number of cases were resistant to the antifungal medicine most recommended for treatment of Candida auris infections.

Unfortunately, misaligned incentives plague the development of new medicines to combat AMR. Developing a new antimicrobial medicine can take 10 to 20 years and just one in 15 products will ultimately be approved and reach patients. Even after approval, stewardship programs designed to slow resistance ensure that newer medicines are used as sparingly as possible, making it challenging for companies to recoup R&D investment. These challenges have been underscored by several high-profile bankruptcies that have occurred over recent years because of funding challenges and lack of commercial sustainability.  

In order to address this growing crisis, we need real solutions. One policy proposal that was just reintroduced this week is the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. The PASTEUR Act provides a commonsense approach to combating the growing threat of AMR by creating needed incentives that will ensure the availability of new antimicrobial products.

Here is what you should know:

• The PASTEUR Act incentivizes companies to develop highly novel antimicrobial medicines. Under the PASTEUR Act, the government would offer “subscription contracts” to manufacturers and create a guaranteed market for novel antibiotics once they're approved by the U.S. Food and Drug Administration (FDA). The intent of the policy is to incentivize companies to develop antimicrobial medicines for infections in which there is unmet medical need, anticipated clinical need or drug resistance.
  
  
• The PASTEUR Act creates a new financial mechanism that delinks payments from volume for government payers. The subscription model under PASTEUR would de-link payment from volume for all U.S. government payers, with contracts offered ranging from $750 million to $3 billion based on certain characteristics of the drug. In exchange, manufacturers would provide the government unlimited access to antimicrobial products subject to a subscription contract for patients covered under federal programs.
  
  
• The PASTEUR Act preserves a reliable supply chain by ensuring appropriate stewardship for companies. Importantly, provisions to ensure appropriate stewardship require companies to develop communications strategies for appropriate use of their drug, as well as submitting a plan for making their products available in countries where unmet medical need exists and ensuring a reliable supply chain.  

With today’s hearing, we applaud policymakers for taking a step in the right direction to fighting AMR and urge them to take this to the finish line. Policymakers should also prioritize inclusion of PASTEUR as part of the September reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) in a renewed effort to fight against emerging public health threats.

Learn more about the threat of AMR.