But a classic end-of-year congressional quagmire — a tight calendar, a heated election season, fights over spending, and inertia — threatens to stymie progress before the end of the year.
If they miss the moment, the bill will get pushed into the next Congress where it could lose momentum, leaving the country unprepared for a growing problem that already costs the U.S. health care system billions of dollars a year.
“We’re playing with fire if we don’t pass this fairly soon,” said Sen. Todd Young (R-Ind.), one of the bill’s lead sponsors. “Every day that passes, we see more deaths on account of antimicrobial resistance, and this situation grows more challenging and more costly.”
For years, the handful of drugmakers developing new antibiotics that fight drug-resistant bugs have struggled to stay afloat. Several companies that have ushered lifesaving drugs through the long, expensive development process have gone bankrupt once they were approved, buckling under the financial pressure of selling a product that, by definition, needs to be used sparingly to preserve its power.
The string of failures has spooked investors, leaving an anemic supply of drugs in development.
The bill, dubbed the PASTEUR Act after French microbiologist Louis Pasteur, would create a “subscription” model for antimicrobial drugs that delinks payments to drug companies from how much medicine they sell, helping them survive financially and preserving the powerful new drugs for infections that don’t respond to any other drug.
Under the proposal, once the FDA approves a drug, the company would apply to the Department of Health and Human Services for a contract that would spread millions — or even billions — of dollars in payments to the firm over time. In exchange, federally insured patients would receive the drug free of cost.
Young and the bill’s other lead sponsors in the House and Senate are eyeing ways to attach the bill to a year-end legislative package — likely one to fund the government for the rest of fiscal 2023. But even they are unsure it will happen this year, citing the bill’s price tag of $11 billion over 10 years as a major stumbling block for lawmakers who have gone months without allocating new funding to Covid-19. A Senate aide familiar with discussions on the legislation said policymakers are working to whittle down the bill’s cost.
If they don’t do it in time, PASTEUR — first introduced in 2020 — will get kicked into the next Congress, where some worry it won’t be a priority if Republicans control one or both chambers.
“We’re at this tipping point right now where we get this passed this year in this Congress or not,” said Aleks Engel, director of the REPAIR Impact Fund of the investment firm Novo Holdings, at the recent AMR World Congress. “If Republicans take over in January, I think there’s a risk they might not prioritize [it], and then it will take awhile.”
The bill’s advocates say that House Minority Leader Kevin McCarthy, the frontrunner for speaker next year should Republicans win control of the House in November, has an interest in antimicrobial resistance and could be a champion for the bill. McCarthy spokespeople didn’t respond to requests for comment.
Experts on superbugs say the cost-benefit analysis should be obvious to lawmakers. Antimicrobial resistance is already a leading global cause of death, killing some 1.7 million people in 2019.
Not only do antibiotic-resistant pathogens result from the misuse of antibiotics, but also these so-called “superbugs” are becoming better at passing on their ability to resist common medicines, experts warn.
“It’s $11 billion over a decade — a billion and change per year,” said Kevin Outterson, executive director of CARB-X, a nonprofit group that invests in treatment, vaccine and diagnostics to fight antibiotic resistance. “Spread across 330 million Americans, it’s about three or four bucks — or a Starbucks latte per American per year — to preserve the most important drug class in human history.”
‘A third rail’
Between 2006 and 2014, the U.S. government invested $225 million in a small biotech company in San Francisco called Achaogen.
Achaogen was working on a promising antibiotic that federal officials thought had the potential to treat multiple health problems, including dangerous drug-resistant blood infections. The Department of Defense, the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) all invested in Achaogen to help the firm get the drug through the exorbitant process of research, development and clinical trials.
They succeeded, and the FDA approved Achaogen’s groundbreaking drug in 2018. But within a year, the company went bankrupt, and it was eventually sold off for a fraction of the government’s investment to an Indian pharmaceutical company.
The dramatic failure of Achaogen and a few other high-profile companies like it have sent investors fleeing from antibiotic development.
“There’s been an almost complete exodus of private investment in new antimicrobials,” said Henry Skinner, CEO of AMR Action Fund, a nonprofit that invests in new antibiotics. “They won’t touch this space. This is a third rail.”
Groups like AMR Action Fund, the REPAIR Impact Fund and CARB-X have cropped up to put some money into the companies working on new drugs, but their leaders don’t see nonprofit investment as a long-term fix.
Since 2010, BARDA, one of the major financial backers of CARB-X, has invested close to $2 billion in antimicrobial resistance, a problem it sees as both a threat to national security in the event of a bioterror attack or a natural disaster and to public health as critical antibiotics’ effectiveness wane.
After Achaogen’s failure, the agency has started supporting some of the companies that it has backed in the challenging post-approval phase. It’s not fixing the root of the problem, but it’s better than doing nothing, said Chris Houchens, director of BARDA’s division of chemical, biological, radiological and nuclear medical countermeasures.
“We’re providing a lot of funding to get products to the point of that FDA approval,” he said. “We keep developing these products to approval and then they risk going off the cliff into financial insolvency.”
Congress wades in
Congress first tried to tackle the antibiotics market problem in 2012, passing legislation to promote the development of new antibacterial and antifungal drugs by creating a fast-track review program for “qualified infectious disease products.” Drugs granted that designation qualify for five extra years of marketing exclusivity, allowing them more time to make more money off the drugs.
Lawmakers went further in 2016, creating another tool dubbed LPAD — the Limited Population Pathway for Antibacterial and Antifungal Drugs — focused on promoting development of medicines for small numbers of patients with life-threatening infections.
Drugs approved under either program can also qualify for new technology add-on payments under Medicare — a three-year bonus payment to hospitals providing those innovative treatments.
But companies were still going out of business even after taking advantage of those programs, said Jocelyn Ulrich, deputy vice president of policy and research at PhRMA, the trade association for the pharmaceutical industry, which supports the PASTEUR Act.
“The effectiveness of those kinds of ‘push’ incentives didn’t address what turned out to be the root cause of the issue in antimicrobial drug development, which is the market failure aspect,” she said.
PASTEUR’s proponents say lawmakers and staff tend to grasp the gravity of the problem when they learn more about it. But getting members to put another expensive health bill at the top of their to-do list before the end of the year will be challenging, they admit.
“Somehow, we’ve got to work that deal through,” retiring Rep. Fred Upton (R-Mich.), who has championed the bill in the House, told POLITICO. “But that’s probably too complex for the waning days of this Congress.”
The bill’s lead sponsors said they aren’t giving up on finding a way to attach it to legislation that advances in the post-midterms lame-duck session. There could be an opening for health care legislation to be attached to a year-end omnibus spending bill — the continuing resolution, H.R. 6833, unveiled late Monday would reauthorize a handful of FDA programs until Dec. 16, creating an incentive for members to revisit other policy riders that didn’t make it into the final user fee agreement.
But it’s an open question whether congressional leaders will feel the same pressure that the bill’s advocates do to enact fundamental changes to the payment system for novel antimicrobial drugs sooner rather than later.
“Congress does a pretty good job of responding to immediate crises or responding after the fact to high-cost crises,” Young said.
The Covid-19 pandemic, he said, is “ a very close analogy to what we’re trying to avoid.”