But a classic year-end congressional quagmire – a tight calendar, a heated election season, battles over spending and sluggishness – threatens to hamper progress before the end of the year.
If they miss the moment, the bill will be pushed to the next Congress, where it could lose momentum, leaving the country unprepared for a growing problem that already costs the US health care system billions of dollars a year.
“We’ll be playing with fire if we don’t pass this on fairly quickly,” said Senator Todd Young (R-Ind.), one of the bill’s main sponsors. “Every day that goes by, we see more deaths from antimicrobial resistance, and this situation is getting more challenging and expensive.”
For years, the handful of drug makers developing new antibiotics to fight resistant insects struggled to survive. Several companies that put life-saving drugs through the long, expensive development process went bankrupt after being approved, succumbing to the financial pressures of selling a product that, by definition, must be used sparingly to maintain its potency.
The string of failures has deterred investors, leaving an anemic supply of drugs under development.
The account, called the PASTEUR law to French microbiologist Louis Pasteur, would create a “subscription model” for antimicrobial drugs that decouples payments to drug companies from how much drugs they sell, helping them survive financially and retain the powerful new drugs for infections that don’t respond to other drugs.
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 company over time. In return, federally insured patients would receive the drug for free.
Young and the bill’s other main sponsors in the House and Senate are looking at ways to tie the bill to a legislative package at the end of the year — likely one to fund the government for the remainder of fiscal 2023. But even they aren’t sure it will happen this year, citing the $11 billion 10-year price tag as a major stumbling block for lawmakers who haven’t allocated new funding to Covid-19 for months. A senate official familiar with discussions of the legislation said policymakers are working to lower the cost of the bill.
“We are now at this tipping point where we either get this in this Congress this year or not,” said Aleks Engel, Director of the REPAIR Impact Fund
If they don’t do it in time, PASTEUR — first introduced in 2020 — will be kicked to the next Congress, where some worry it won’t be a priority if Republicans control one or both chambers.
“We are now at this tipping point where we may or may not get this passed in this Congress this year,” Aleks Engel, director of the REPAIR Impact Fund of investment firm Novo Holdings, said at the recent AMR World Congress. “If Republicans take over in January, I think there’s a risk that they won’t prioritize.” [it]and then it will take some time.”
The bill’s proponents say Kevin McCarthy, leader of the minority group in the House, the frontrunner for speaker next year if Republicans gain control of the House in November, has an interest in antimicrobial resistance and could be a champion of the bill. . McCarthy spokespersons did not respond to requests for comment.
Superbugs experts say the cost-benefit analysis should be clear to lawmakers. Antimicrobial resistance is already one of the leading causes of death worldwide, killing some 1.7 million people in 2019.
Not only are antibiotic-resistant pathogens the result of antibiotic misuse, but these so-called “superbugs” are getting better at passing on their ability to resist common drugs, experts warn.
“It’s $11 billion over a decade — a billion and change a year,” said Kevin Outterson, executive director of CARB-X, a nonprofit group that invests in treatment, vaccine and diagnostics to fight antibiotic resistance. “Spreading 330 million Americans, it’s about three or four dollars — or one Starbucks latte per American per year — to preserve the most important drug class in human history.”
‘A third track’
Between 2006 and 2014, the US government invested $225 million in a small San Francisco biotech company called Achaogen.
Achaogen was working on a promising antibiotic that federal officials believed could 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) have all invested in Achaogen to help the company get the drug through the exorbitant process of research, development and clinical trials.
They succeeded, and the FDA approved Achaogen’s breakthrough drug in 2018. But within a year, the company went bankrupt and was eventually sold 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 has sent investors fleeing the development of antibiotics.
“There has 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 track.”
Groups like AMR Action Fund, the REPAIR Impact Fund and CARB-X have sprung up to put some money into the companies working on new drugs, but their leaders don’t see investing in nonprofits as a long-term solution.
Since 2010, BARDA, one of CARB-X’s main funders, has invested nearly $2 billion in antimicrobial resistance, an issue it sees as a threat to national security in the event of a bioterror attack or natural disaster, as well as to public health. as the effectiveness of critical antibiotics decreases.
Following Achaogen’s failure, the agency has begun supporting some of the companies it has backed in the challenging post-approval phase. It doesn’t solve the root of the problem, but it’s better than doing nothing, says Chris Houchens, director of BARDA’s chemical, biological, radiological and nuclear-medical countermeasures division.
“We’re providing a lot of money to get products to FDA approval,” he said. “We continue to develop these products until they are approved and then they risk sliding off the cliff into financial insolvency.”
Congress wades in
Congress first attempted to address the antibiotics market problem in 2012 and passed legislation to promote the development of new antibacterial and antifungal agents by creating an accelerated review program for “qualified infectious disease products.” Drugs that receive that designation qualify for an additional five years of marketing exclusivity, giving them more time to monetize the drugs.
Lawmakers went further in 2016 and created another tool called LPAD – the Limited Population Pathway for Antibacterial and Antifungal Agents – aimed at promoting drug development for small numbers of patients with life-threatening infections.
Drugs approved under both programs may also qualify for additional payments for new technology under Medicare — a three-year bonus payment to hospitals that provide these innovative treatments.
But companies still went bankrupt even after taking advantage of those programs, said Jocelyn Ulrich, deputy vice president of policy and research at PhRMA, the pharmaceutical industry trade association that supports the PASTEUR bill.
“The effectiveness of these types of ‘push’ incentives did not solve the root of the problem in antimicrobial drug development, which is the market failure aspect,” she said.
PASTEUR proponents say lawmakers and staff tend to understand the seriousness of the problem when they learn about it. But getting members to put an expensive health bill at the top of their to-do list again before the end of the year will be a challenge, they admit.
“Somehow we have to get through that deal,” retired Representative Fred Upton (R-Mich.), who defended the bill in the House, told POLITICO. “But that’s probably too complex for the waning days of this Congress.”
The bill’s main sponsors said they’re not giving up on finding a way to tie it to legislation that moves forward in the lame-duck session after the midterms. There could be an opening to tie health care legislation to a year-end omnibus spending bill – the ongoing resolution, HR6833revealed late Monday would reauthorize a handful of FDA programs through Dec. 16, giving members an incentive to revisit other policymakers who failed to make the final user-fee agreement.
But it’s an open question whether congressional leaders will feel the same pressure as the bill’s proponents to make fundamental changes to the payment system for new antimicrobial drugs sooner rather than later.
“Congress reacts fairly well to immediate crises or reacts to expensive crises afterwards,” Young said.
The Covid-19 pandemic, he said, is “a very close analogy to what we are trying to avoid.”
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