Melanie Lawrence doesn’t think she’ll live long enough to see her son graduate college.
Lawrence, a patient with cystic fibrosis from Massachusetts, has been on antibiotics almost her whole life. Throughout her childhood and early teenage years, the antibiotics were “highly effective,” but with Lawrence now in her 40s, “the bacteria in my lungs are resistant to nearly all antibiotics,” she told the Senate HELP subcommittee on primary health & retirement security at a hearing on antimicrobial resistance (AMR) Tuesday.
“The discovery of antibiotics revolutionized modern medicine,” increasing the average human lifespan by 23 years, said the subcommittee’s chairman Sen. Ed Markey (D-Mass.) in his opening statement. “But the rise of antimicrobial resistance threatens to undo 100 years of medical progress.” Around the world, AMR has been linked to 5 million deaths per year, and this number is estimated to skyrocket to 10 million annual deaths by 2050. In the U.S, resistance to antibiotics caused an estimated 2.8 million infections and 35,000 deaths annually, according to data released by the Centers for Disease Control and Prevention in 2019.
Given the Generating Antibiotic Incentives Now (GAIN) Act in 2012 and existing programs like CARB-X, the problem is not innovation or approval of new antibiotics, according to Christine Ann Miller, CEO of Melinta Therapeutics and chair of the pharma- and biotech-led Antimicrobials Working Group. “What we do have is a commercial marketplace problem,” she testified at the hearing, “that is fundamentally unique to antimicrobials.”
Ranking Member Roger Marshall (R-Kan.) articulated this conundrum in his opening statement: “When we develop these types of antibiotics, we’re hopefully only going to use them each a handful of times. And it just makes the economics of it next to impossible.”
The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
The Pasteur Act has been introduced in Congress three times since 2019, with the price tag of the bill slashed from $11 billion to $6 billion in the most recent iterations. Last year, lawmakers supporting the bill tried to fold it into the must-pass National Defense Authorization Act, but a coalition of academics and advocacy groups criticized the Pasteur Act as a “blank check” for the pharmaceutical industry, providing billions of dollars for newly developed drugs with little added value. In Tuesday’s hearing, none of the witnesses voiced these concerns.
There may be a renewed eagerness in Congress to address AMR. In April, the House Energy & Commerce Committee convened a parallel hearing on “Antimicrobial Resistance: Examining an Emerging Public Health Threat” that similarly touched on the Pasteur Act. And during Tuesday’s hearing, the Senators all seemed to be fairly supportive of reform, with Sen. Mike Braun (R-Ind.) articulating the need for shore up the antibiotics pipeline for the sake of preparedness and Sen. Tina Smith (D-Minn.) saying that the U.S. needed to invest in the development and manufacturing of antibiotics, while also fixing the broken market. However, the subcommittee offered no specific action items regarding how Congress should respond.
Boucher emphasized all the progress that’s been made with existing AMR programs, with over 90 early-stage candidates and diagnostics funded and over a dozen products in clinical trials. But she also emphasized the stakes of inaction. “If we don’t see progress on something like the Pasteur Act, all that investment will go to waste, and those medicines won’t get to our patients.”