Congress Needs to Fix the Broken Market for Antibiotic Development

For decades world health leaders and experts repeatedly warned that it was only a matter of time before a global pandemic — one as deadly as the 1918 influenza epidemic — struck. COVID-19 proved they were right. These same voices are now issuing another persistent warning that today’s leaders need to heed: Antibiotic resistance is a dire, growing threat that puts lives and public health at risk. 

Antibiotics — once considered “miracle drugs” but now gradually losing their effectiveness — underpin almost every aspect of modern medicine. So, without urgent action to develop new antibiotics, we face a world where so-called “superbugs” will not respond to many, or in increasing cases, any existing antibiotics. That’s why Congress should pass the Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2021, also known as the PASTEUR Act, to stimulate the development of new drugs to fight deadly bacterial infections.

The World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and countless scientific organizations and researchers agree: The antibiotics we count on to cure infections are losing efficacy. Here’s why: The more we use antibiotics, the faster bacteria evolve and develop resistance to them. That’s how we end up with pathogens that can’t be defeated. Humankind is essentially in an arms race with bacteria, and we’re in danger of losing. CDC estimates that more than 2.8 million people develop resistant infections each year in the United States, and more than 35,000 die. 

But despite the urgency, the global research and development pipeline for new antibiotics is running dry. Unlike blockbuster cancer therapies or drugs that people take for years to control high blood pressure, antibiotics must be used judiciously to preserve their effectiveness. And their use is typically discontinued as soon as an infection is cured. That’s one reason antibiotics have not provided a strong return on investment for pharmaceutical companies. From 2014 to 2016, drug companies made more than $8 billion on cancer drugs, but lost $100 million on antibiotics. This poor return on investment also discourages private investment in new antibiotics. In 2019, investors poured $9.7 billion into oncology research, but committed only $132 million to antibiotics research.

Additionally, hospitals and health systems have begun to implement much-needed antibiotic stewardship programs to reduce inappropriate antibiotic use and preserve the drugs’ efficacy. This is a wise decision, but another factor that sharply limits sales of new antibiotics. Few drug companies find it feasible to spend more than $1 billion to create an affordable drug that is meant to sit on the shelf for as long as possible.

These market factors have led almost every large pharmaceutical company to leave the field in recent years. In 2014, eight big drugmakers had an antibiotic in the clinical pipeline; last year only two did. The pipeline of new antibiotics in clinical development is woefully insufficient, and our current antibiotics are all based on discoveries from over three decades ago.

That’s why Congress needs to step in to stimulate the pipeline and provide incentives for industry and private investors to reenter the field and commit resources to antibiotics innovation. The bipartisan PASTEUR Act would do that. Introduced by Sens. Michael Bennet (D-Colo.) and Todd Young (R-Ind.) and Reps. Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.), the bill addresses the market challenges by delinking revenue from sales volume. This bill would allow the federal government to offer contracts to drug companies, providing them with a fair return on investment for the risk they incur to develop a new antibiotic based on the drug’s value to public health. Eligibility for these contracts would be determined by a specially appointed committee within the Department of Health and Human Services, and by an advisory group including infectious disease specialists, health experts and patient advocates.

The legislation would carefully target government incentives to drive development of high-priority, novel drugs designed to thwart the most dangerous bacteria. It would also provide funding to facilitate increased tracking of antibiotic use and strengthen antibiotic stewardship initiatives that help preserve the effectiveness of all antibiotics. These steps would maximize the value of new antibiotics for taxpayers and patients long after these drugs go to market. Additionally, the bill would require companies eligible for the contracts to agree to certain conditions, including guaranteeing supply and providing the antibiotics to federal payers, such as Medicare, for free.

Passing the PASTEUR Act would be a significant victory, but winning the war against antibiotic resistance will require a sustained effort and more reforms over time. For example, Congress should consider reimbursement reform to make sure that insurers pay hospitals a fair rate for antibiotics, with stewardship provisions included to promote appropriate use of these drugs. New antibiotics can be expensive, so this change would help providers make sure that patients get the new drugs they need without worrying about the high cost. This step, in turn, will stabilize the market while improving access to these life-saving medications.  

COVID-19 showed that global experts were right about the threat of a new worldwide pandemic. They’re also right about the global threat of growing antibiotic resistance, and the United States needs to prepare now. Starting with the PASTEUR Act, Congress can safeguard our nation’s health, incentivize the private sector to develop the antibiotics that the country needs, and give physicians and public health leaders a fighting chance at keeping these miracle drugs working for the next generation. Policymakers should act now.

Kathy Talkington directs health programs at The Pew Charitable Trusts.

This piece was originally published in The Hill.