Developing the antibiotics we need

A similar version of this post appears on our partner PIRG’s website.

Antibiotics make chemotherapy and many surgeries and procedures possible and are a cornerstone of modern medicine. They’ve saved millions of lives. However, despite their significant societal value, new development is limited because the financial incentives for developing other drugs don’t work for antibiotics.

At a time when many commonly used antibiotics are waning in effectiveness, we need a new approach to bringing new antibiotics through the pipeline. Non-profit drug development is one such option.

What’s the problem with the development of new antibiotics?

For most types of drugs, incentives such as patent protection and market exclusivity create a potential windfall for a drug developer to recoup its investment. However, that’s not the case for antibiotics for two reasons. First, compared to other types of drugs, patients tend to need antibiotics for a very limited time. For instance, a person who gets bacterial pneumonia will take antibiotics for a matter of days, while someone with diabetes or another chronic condition might take a drug for years or even decades. Second, the more that an antibiotic is used, the faster it loses its efficacy (and therefore loses its value).

To make matters worse, existing incentives encourage companies to try to game the system by creating variants of existing antibiotics – so-called “me too” drugs – that we don’t need. As a result, there aren’t enough antibiotics in development to treat priority pathogens like drug-resistant strains of Acinetobacter baumannii and Pseudomonas aeruginosa. These and other antibiotic-resistant bacteria kill at least 35,000 Americans and sicken 2.8 million each year, making antibiotic resistance a public health crisis. We need something other than the regular incentives if we’re going to succeed in developing new, critically needed antibiotics.

The PASTEUR Act, which was introduced in Congress in 2020 and reintroduced in May 2023, is one proposed solution to this problem. The bill would reward the developer of a newly approved antibiotic with a contract of $750 million to $3 billion to produce the drug, maintain its supply chain, provide as much of the drug as is needed for Medicare and Medicaid patients and abide by various stewardship commitments to help ensure the drug is used judiciously. While the bill has a lot of support from experts in the infectious disease and pharmaceutical fields, there is reason to be concerned that it is not an efficient use of taxpayer money and may end up amounting to a giveaway to the pharmaceutical industry for drugs that won’t improve our health.

So, what’s the alternative?

An alternative solution is to create and publicly fund a new non-profit organization to develop critically needed antibiotics much more cost-effectively.

Non-profit drug development might seem radical given our traditional for-profit, patent-driven model. However, it has several advantages and has already delivered a tuberculosis drug. A non-profit can tackle public health priorities instead of being laser-focused on maximizing return on investment by pursuing “me too” drugs. Rather than disrupting the free market, a non-profit can complement the current system by selling intellectual property to a for-profit drug developer later in clinical trials with strict stewardship standards. With some or most of the investment risk mitigated, other drug developers will be better poised to bring antibiotics through the pipeline and manufacture them. Finally, while for-profit drug developers may not be inclined to pursue an antibiotic with low profit potential, non-profit drug developers can reinvest even modest sales revenue into research and development for new antibiotics.

The primary disadvantage of non-profit antibiotic development is the hundreds of millions of dollars of government funding needed to start such a venture. However, that price tag pales in comparison with the $6 billion pool proposed in the PASTEUR Act.

Our partners at PIRG and other public health advocates are championing this approach, which brings with it the promise of developing new antibiotics in step with the need for them – and saving thousands, and perhaps millions, of lives.