The relentless pace of antibiotic resistance is well known. What to do about it is less clear. The inadequate pipeline of potential new drugs has been a concern for years, prompting frequent debates about whether and how the government should help. With recent studies showing that antibiotic-resistant infections are on the rise and more deadly than previously thought, the new Congress should address the issue, learning from the shortcomings of previous attempts to jump-start the development of antibiotics.
Antibiotics are used for a short, defined treatment and they are ideally prescribed sparingly to avoid overuse. The return on investment is often insufficient to cover research costs or satisfy shareholders. By the late 1990s and through the 2000s, the pipeline of new antibiotics being developed had shrunk. Methicillin resistant Staphylococcus aureus and drug-resistant tuberculosis sounded the alarm; moreover, the so-called gram-negative bacteria were increasingly resistant to antibiotics.
A period of renewed action followed. In 2012, Congress passed the Generating Antibiotic Incentives Now Act, which offered antibiotic developers an expedited regulatory track for new antibiotics as well as five years of additional market exclusivity to sell their new drugs. “Incentive” incentives, such as direct grants for research and development, and “incentive” incentives, to reward those who succeed, have also been offered. 2016 saw the launch of CARB-X, a nonprofit public-private partnership at Boston University to help advance the development of new antibiotics for the most pressing public health threats. After the 2016 passage of the 21st Century Cures Act, the Food and Drug Administration relaxed clinical trial requirements for certain antibiotics and antifungals. The result of these incentives was modest: there was an increase in the number of new antibiotics, but they often duplicated existing ones and few addressed unmet needs.
This has led to a renewed search for political models that might work. The traditional path of biotechnology – backed by investors – is fraught with pitfalls. Small companies are still striving to create new antibiotics, but the field was rocked by the 2019 bankruptcy of Achaogen, a biotech company that had received government incentives and support, developed an antibiotic drug against resistant pathogens that got FDA approval – and still couldn’t make enough profit to stay afloat.
A major new proposal that followed was the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance or Pasteur Act, first introduced by the Sens. Michael F. Bennet (D-Colo.) and Todd C. Young (R-Ind.) in 2020. The legislation would create a “subscription model” in which the government would pay developers $750 million at 3 billions of dollars each for antibiotics that target unmet needs. The government would only pay once, decoupled from the volume of drugs used, after the antibiotics were developed and approved. The proposal had bipartisan support in both houses but failed to clear the 117th Congress; it will be reintroduced this year.
The Pasteur Act is backed by Pharmaceutical Research and Manufacturers of America (PhRMA), the biopharmaceutical lobby, although it has never previously supported such a government procurement contract program. Jocelyn Ulrich, assistant vice president of policy and research at PhRMA, explained the reasoning: “More than ten years ago, I think 18 to 20 big pharma companies were still in this space, and now we don’t. “We’re down to a handful. The market momentum just isn’t there. It’s not sustainable. Everyone is kind of on board now that we have a market failure in this area particular.
The Pasteur law could help drug developers get a predictable return on investment, but the $11 billion price tag has been criticized as excessive. Some see a parallel to the roughly $10 billion Operation Warp Speed, the coronavirus vaccination effort during the pandemic. But antibiotic resistance is not a one-time problem. Rather, it requires years of commitment to research, ultimately creating a steady pipeline of effective new antibiotics.
Another interesting model would be to create an association, which is being tested with tuberculosis and malaria. Brad Spellberg, chief medical officer of Los Angeles County Medical Center and the University of Southern California, was one of the strongest advocates of the incentive approach a decade ago, but he has now proposed to create a non-profit organization to promote the discovery of antibiotics. Dr Spellberg and others wrote in the New England Journal of Medicine in 2019: “A drug with annual sales in the tens of millions of dollars is a catastrophic failure for many for-profit companies, but would be a lifeline. rescue for nonprofits…” A nonprofit wouldn’t have to worry about quarterly results or pesky shareholders, and it could use the proceeds from the sale of its new antibiotics to fuel new research . He might still need to rely on for-profit companies in later stages of drug development to license or sell the products. It might also require start-up funds from the government, but it “might be a better long-term investment than perpetually offering multi-billion dollar prizes or other pull incentives for every new antibiotic.” , explained Dr. Spellberg.
Congress should explore both approaches, and quickly. The end of the antibiotic era – when a doctor has nothing left to treat an infection – is too horrifying to contemplate. Waiting is not a reasonable option.
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