Can a ‘Netflix model’ fix the broken market for antibiotics?
Recent shortages of amoxicillin, an effective antibiotic that pediatricians have long relied on to treat strep throat and ear infections in children, have put a spotlight on an urgent global threat: the world’s shrinking arsenal of potent antibiotics and the lack of incentives to develop them.
The broken marketplace for new antimicrobial drugs has stirred debate over a bill, languishing in Congress, that would dramatically reconfigure the way antibiotics are discovered and sold in the United States.
The $6 billion measure, the Pasteur Act, would upend the conventional model that ties antibiotic profits to sales volume by creating a subscription-like system that would provide pharmaceutical companies an upfront payment in exchange for unlimited access to a drug once it is approved by the Food and Drug Administration.
Some call it Netflix model for antibiotics.
The measure attempts to address the vexing economics of antibiotics: Promising new drugs often gather dust on pharmacy shelves because health providers would rather save them for patients whose infections don’t respond to existing ones. That’s because the more frequently an antibiotic is used, the more quickly it will lose its curative punch as the targeted bacteria develop the ability to survive.
New antibiotics also tend to be expensive, a disincentive for hospital-based prescribers who will often turn to cheaper ones, making it even harder for drug companies to earn back their initial investment. Aside from the shortages of drugs that still work, the shrinking toolbox of effective antimicrobials has become a silent global crisis that claims nearly 1.3 million lives a year. By 2050, the United Nations estimates that drug-resistant pathogens could kill 10 million people annually.
“If we want antibiotics to work for our the
kids, our grandkids or ourselves in 10 years, we have to invest in the infrastructure today,” said Kevin Outterson, executive director of CARB-X, a nonprofit that provides funding for small biotechs developing novel antibiotics.
By separating profits from sales volume, supporters of the bill hope that prescribers will save new drugs for patients whose infections are resistant to existing medications. Limiting their use, experts say, can help extend the life of a new antibiotic before evolutionary pressure creates a “superbug” all but impervious to available antimicrobials.
The bill, a decade in the making, has bipartisan support and is widely backed by researchers, health care policy experts and drug company executives. But as momentum for the bill has gained steam, opposition has emerged from a small group of doctors and health care advocates, many of them critics of Big Pharma. They say the bill is a drug-industry giveaway — and unlikely to address the problem of antibiotic resistance.
The legislation’s prospects seemed grim in the final weeks of a lame duck session during which lawmakers often race to push through unfinished legislation. Concerns over cost had already prompted mainly Republican lawmakers to reduce its price tag by $5 billion, and Congress has been anxious to push through a final spending deal before the holidays.
“The COVID-19 pandemic demonstrated America’s vulnerability to catastrophic public health crises, and it highlighted the urgency of taking reasonable measures to prevent them in the future,” Sen. Todd Young, R-ind., one of the bill’s co-sponsors, said in an email. “The next public health crisis is already here: the emergence of bacteria resistant to antibiotic treatment.”
In a letter to Congress, opponents of the measure said it would encourage the development of ineffective drugs, in part because of what they describe as flaws in the FDA’S approval process for antibiotics. “Under the Pasteur Act, taxpayer dollars will be wasted as a blank check to pharmaceutical manufacturers for antimicrobials of limited benefit,” they wrote.
One of the signers, Dr. Reshma Ramachandran, an assistant professor at the Yale School of Medicine, said the bill leaves in place a regulatory regimen for antibiotics that she and others contend allows companies to market drugs of questionable value. Her objection to the status quo centers on a central tenet of the FDA’S antibiotics review process: New drugs can be approved under a concept known as noninferiority, which allows novel medications to be less effective than existing ones. Ramachandran, whose work focuses on antimicrobial resistance and health policy, and other critics of the bill said that the FDA should adopt a system that requires drugmakers to prove that new antibiotics are superior to current ones.
“As a clinician, it’s a huge concern for me that we could have new costly drugs on the market without regulatory oversight to actually ensure these drugs are clinically meaningful or that they even address resistant infections,” Ramachandran said.
Many experts, however, say that such an approach is impractical and raises ethical questions. To establish whether a new antibiotic is superior to existing ones, researchers would have to conduct clinical trials that test the new therapy against a placebo or a drug they know to be less effective. For study participants battling an infection, getting a placebo or an inferior drug could prove deadly.
“This whole superiority notion makes no sense. We don’t hold any drug to that standard,” said Kenneth Thorpe, a health policy official in the Clinton administration who is an adviser to the advocacy group Partnership to Fight Infectious Disease. “We need to spur innovation and get as many novel antibiotics as we can given the diversity of infections and the threat to human health if we fail.”
Over the 10-year life of the legislation, the federal government would make payments ranging from $750,000 to $3 billion to companies making “critical need antimicrobials.” An analysis by the Center for Global Development estimated that the $6 billion price tag for the legislation would yield $32 billion in savings over a decade and save 20,000 lives in the United States and 518,000 around the world.