Why the Antibiotic Pipeline Is Broken—and How to Fix It

Antibiotic resistance can be slowed but never stopped, so society will always need new drugs.

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Scientific, economic, and regulatory barriers have led many major pharmaceutical companies to limit or stop investing in antibiotic innovation, just as the rise of resistant “superbugs” makes it more important than ever to develop novel antimicrobial drugs. The world needs new, targeted scientific research and innovative policies to revitalize the drug pipeline, produce new treatments, and address the challenge of antibiotic resistance.

Antibiotic resistance can be slowed but never stopped, so society will always need new drugs. Yet only a few drugs are in development with the potential to defeat the most serious bacterial threats.

In June 2016, The Pew Charitable Trusts, Wellcome, and the American Society for Microbiology convened leading experts to determine what can be done. Participants laid out what a robust and sustainable pipeline should look like, and what changes are needed to produce effective antibiotics that will meet patient needs in the short and long term.

The group agreed that revitalizing the pipeline will require concerted effort among stakeholders—industry, government, nonprofits, and academia—acting together to advance antibiotic discovery and development. New programs that bring scientists back to the antibiotic discovery space are vital to build a community of innovators that can cultivate a strong pipeline.

For example, targeted, multidisciplinary, basic science research, as outlined in a Pew report, A Scientific Roadmap for Antibiotic Discovery, would help scientists overcome barriers impeding the discovery of new types of antibiotics and novel therapies. And ongoing initiatives, such as the Combating Antibiotic-Resistant Bacteria Accelerator (CARB-X), will support the early stage development of promising products to fight resistant bacteria. These efforts are encouraging and offer hope that a more sustainable pipeline of antibiotics could be on the horizon.

To address the unmet medical needs that patients face today—such as life-threatening bacterial infections that are resistant to available therapies—and to stay ahead of future epidemics, stakeholders must make full use of existing regulatory tools to balance risk, benefit, and uncertainty in bringing high-need antibacterial agents to market. The limited-population antibacterial drug pathway, recently authorized in a U.S. health law, and the adaptive pathways approach being explored by the European Medicines Agency are examples of ways to enable companies to develop urgently needed new antibiotics while maintaining safety and effectiveness standards.

Others have proposed new business models for antibiotics in which governments and insurance companies would pay more for these drugs in exchange for certain commitments from manufacturers. Such efforts, like those being explored by the European Innovative Medicines Initiative DRIVE-AB project and the Duke-Margolis Center for Health Policy, may help attract investors and pharmaceutical companies to antibiotic research and development.  

Before the advent of antibiotics, simple infections accounted for at least one-third of all deaths in the U.S. Just 100 years ago, soldiers died not of their battlefield wounds but of subsequent infections; a raging infection could kill a healthy adult in a matter of days. It may be hard to imagine, but unless scientists, drug developers, policymakers, and other key stakeholders can revitalize the antibiotic pipeline, we could see a return of those terrible days.

To ensure that a world without antibiotics remains a thing of the past, society must be prepared. Much as we find societal value in having fire departments at the ready and fire extinguishers in our homes, we must recognize that antibiotics are very much the fire extinguishers of medicine, and we must invest now in research and development to ensure that a sufficient array of effective antibiotics exists in the decades to come.

As we stand at a global tipping point, we must all work together—with urgency—to solve this problem and ensure that our level of preparedness matches the magnitude of the threat posed by increasingly resistant bacteria.

John Rex is a physician and drug developer with 30 years of development and policy experience focused on antimicrobial agents. Allan Coukell directs health programs at The Pew Charitable Trusts.