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 subject of concern for years, prompting frequent debate about whether and how the government should help. With recent studies showing that antibiotic-resistant infections are on the rise and more lethal than previously thought, the new Congress should take on the issue, learning from the shortcomings of previous attempts to jump-start antibiotic development.
Antibiotics are used for a short, defined course 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 during the 2000s, the pipeline of new antibiotics under development had shrunk. Methicillin-resistant Staphylococcus aureus and drug-resistant tuberculosis raised alarms; additionally, so-called gram-negative bacteria were proving evermore resistant to antibiotics.
A period of renewed action followed. In 2012, Congress passed the Generating Antibiotic Incentives Now Act, which offered antibiotic developers a fast-track regulatory pathway for new antibiotics as well as five years of additional market exclusivity in which to sell their new drugs. Both “push” incentives, such as direct grants for research and development, and “pull” incentives, to reward those who succeed, were offered as well. In 2016 came the launch of CARB-X, a nonprofit public-private partnership at Boston University to help advance development of new antibiotics aimed at the most urgent public health threats. After passage in 2016 of the 21st Century Cures Act, the Food and Drug Administration eased clinical trial requirements for some antibiotics and antifungals. The result of these incentives was modest: There was an uptick in new antibiotics but they were often duplicative of existing ones and few addressed unmet needs.
This has led to a renewed search for policy models that might work. The traditional biotech route — backed by investors — is fraught. Small companies are still striving to create new antibiotics, but the field was shaken by the 2019 bankruptcy of Achaogen, a biotech company that had benefited from incentives and government support, developed an antibiotic drug against resistant pathogens that won FDA approval — and still could not make a sufficient 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 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 provide developers payments of $750 million to $3 billion each for antibiotics that target unmet needs. The government would pay only once, decoupled from the volume of medicine used, after the antibiotics are 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 before supported such a large government purchase contract scheme. Jocelyn Ulrich, deputy vice president of policy and research at PhRMA, explained the reasoning: “Over a decade ago, I think 18 to 20 major pharmaceutical companies were still in this space, and now we’re down to just a handful. The market dynamics are just not there. It’s not viable. Everybody sort of agrees now that we have market failure in this particular area.”
The Pasteur Act might help drug developers get a predictable return on investment, but the $11 billion price tag drew criticism as excessive. Some see a parallel with the approximately $10 billion Operation Warp Speed, the crash coronavirus vaccine effort during the pandemic. But antibiotic resistance is not a one-time “moonshot” problem. Rather, it demands years of commitment to research, ultimately creating a steady pipeline of effective, new antibiotics.
Another interesting model would be to create a nonprofit, which is being tried with tuberculosis and malaria. Brad Spellberg, chief medical officer of the Los Angeles County and University of Southern California Medical Center, was one of the most vocal advocates of the incentives approach a decade ago, but now has proposed creating a nonprofit to nurture antibiotic discovery. 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 for nonprofits …” A nonprofit would not have to worry about quarterly results or pesky shareholders, and it could use proceeds from selling its new antibiotics to fuel further research. It might still need to rely on for-profits in later drug development stages to license or sell the products. It also could require some seed money from the government, but that “might be a better long-term investment than perpetually offering multibillion-dollar prizes or other pull incentives for each new antibiotic,” Dr. Spellberg argued.
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 horrible to contemplate. Waiting is not a reasonable option.
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