A bipartisan group of US lawmakers is taking another shot at legislation that advocates hope could boost antibiotic development efforts.
The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, reintroduced last week by five members of the US House of Representatives, aims to revitalize the antibiotic and antifungal development pipeline by changing how the federal pays for novel antimicrobials. The bill was first introduced in Congress in 2020 and re-submitted in subsequent years but has never received a floor vote.
The legislation would create a payment model under which the federal government would sign a subscription-style contract with pharmaceutical companies that develop critically needed new antibiotics and antifungals. The companies would receive fixed annual payments from the government, ranging from $75 million to $300 million per year, based on how innovative their product is, how much it contributes to patient care, and how beneficial it is for public health.
The bill’s sponsors say it will help tackle the market challenges that have hindered antibiotic development and will strengthen public health preparedness against antimicrobial resistance (AMR). More than 2.8 million drug-resistant infections occur in the United States each year, causing an estimated 35,000 deaths. And those numbers are expected to rise as AMR spreads.
“The United States leads the world in medical innovation, and we must ensure our policies reflect that,” lead sponsor Buddy Carter (R-GA) said in a press release. “As a pharmacist, I’ve seen nothing short of miracles due to drug development in my lifetime, but we must continue to evolve to combat antimicrobial resistance.”
The bill’s other sponsors include Scott Peters (D-CA), Nick Langworthy (R-NY), Mike Levin (D-CA), and Mike Carey (R-OH).
New bill addresses some shortcomings
The idea behind the subscription-style model is to delink pharmaceutical companies’ profits from the volume of antibiotics sold. Current contracts between the government and drug makers base payment on volume. But unlike many other medications, antibiotics are used only for a limited time. And to prevent the development of resistance, new antibiotics are used sparingly and reserved mainly for infections that are resistant to older drugs.
Antibiotic development advocates say the broken market, along with a challenging regulatory environment, have contributed to a thinning pipeline of new antibiotics at a time when AMR is reducing the effectiveness of current antibiotics. Many large pharmaceutical companies have abandoned antibiotic and antifungal development because antibiotics simply don’t provide enough of a return on investment to justify the costs. At the same time, several of the smaller biotechnology companies that now dominate the space have had to declare bankruptcy, even after having new products approved by the Food and Drug Administration.
The hope is that the predictable payments provided through this model, a version of which has already been launched in the United Kingdom through its National Health Service, will boost private investment and encourage companies to keep developing innovative antibiotics.
“Restoring a functional and predictable market is essential to rekindling private investment in this lifesaving field of medicine,” Henry Skinner, PhD, of the AMR Action Fund said in an emailed statement. “Without meaningful progress on policy reform, we are likely to see more biotechnology companies developing urgently needed antibiotics fail this year, not because the science falls short, but because the broken market offers no way to sustain success.”
The United States leads the world in medical innovation, and we must ensure our policies reflect that.
Although the bill has had widespread bipartisan support in the past, advocates say the updated PASTEUR Act includes improvements they believe will address shortcomings raised by some lawmakers. The primary improvement is a scoring system that would determine which products will be eligible for government contracts, said Amanda Jezek, senior vice president of public policy and government relations at the Infectious Diseases Society of America (IDSA), which worked closely with the sponsors to recraft the legislation.
“People just found the bill to be a little too complicated in terms of the new funding mechanism and how it would work, and whether we could really be sure that it would yield really good drugs,” Jezek told CIDRAP News. Among the concerns was that the Department of Health and Human Services might have too much discretion in deciding which products get contracts, and how big those contracts should be.
Jezek said the new scoring mechanism, which will score new antibiotics from companies seeking contracts based on how innovative they are, how much they improve patient outcomes, and how much they benefit public health, will add some clarity and transparency to the process.
“A drug has to meet a certain scoring threshold in order to get a contract at all, and then, depending on how high that score is above that minimum threshold, that will determine how big that contract is,” Jezek explained.
Other additions include the creation of a committee—made up of infectious diseases physicians, antibiotic resistance experts, and patient advocates—to guide the design program. And while previous versions of the bill have included antibiotic stewardship requirements, the bill contains a new provision that would fund pilot programs for implementing and expanding stewardship efforts in outpatient settings, where a significant amount of unnecessary antibiotic prescribing occurs.
“There’s just not a lot of strong stewardship infrastructure yet in outpatient settings…so we’re really excited about that,” Jezek said. “I think it really helps further demonstrate that this bill is not only about antibiotic development—which is certainly crucial—but is really trying to look at AMR in a bigger-picture way.”
