New Agency Leadership Must Prioritize the Fight Against Antibiotic Resistance

Federal emergency preparedness office in HHS can help protect U.S. from superbugs

New Agency Leadership Must Prioritize the Fight Against Antibiotic Resistance
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With the nation making daily progress against COVID-19, federal policymakers also must prepare for another lurking global health threat: antibiotic resistance. Dawn O’Connell, confirmed June 24 as assistant secretary for preparedness and response with the Department of Health and Human Services, should now set a proactive agenda to combat the threat of superbugs.   

These antibiotic-resistant pathogens develop as they are exposed to antibiotics and become more dangerous and difficult to treat in the process. In recent years, bipartisan momentum has grown to fight back against these superbugs. Under O’Connell, the Office of Assistant Secretary for Preparedness and Response (ASPR) should prioritize increased access to antibiotics and intensify efforts to help develop urgently needed new ones. These strategies will be key components in battling the dangerous infections caused by pathogens that too often don’t respond to existing drugs.

The assistant secretary and her team have several opportunities to advance the fight against such superbugs. First, the office can take steps to address the broken antibiotics market and encourage development of new antibiotics to ensure the U.S. is better prepared to combat drug-resistant pathogens.

Right now, there isn’t a viable commercial market for most antibiotics despite their critical role in modern medicine. These drugs are extremely resource-intensive to develop, but companies face difficulties recouping their investments, in part because antibiotics must be used only when needed to avoid contributing to resistance. Consequently, many companies are exiting the market or going bankrupt, resulting in an insufficient pipeline to supply the new drugs that patients and providers need.

To address these market challenges, ASPR should allocate more funding to the Biomedical Advanced Research and Development Authority (BARDA)—the HHS office under ASPR dedicated to advanced drug development—and its targeted investments in what are known as broad-spectrum antimicrobials effective against a wide range of bacteria.

By increasing BARDA’s budget to support late-stage antibiotic development, ASPR can alleviate financial constraints for companies seeking approval from the Food and Drug Administration for promising antibiotics. This would strengthen the pipeline for drugs that have proved effective against the most dangerous infections.

BARDA also can help expand antibiotic development by increasing funding for the Combating Antibiotic-Resistant Bacteria Accelerator (CARB-X), a critical public-private partnership that helps drive early-stage research and development. Allocating more resources to CARB-X would lay the groundwork for more successful new antibiotics down the road.

Second, ASPR can better prepare the U.S. to respond to superbugs by expanding the types of antibiotics in the country’s Strategic National Stockpile (SNS). In its disaster preparedness role, ASPR manages the SNS so it can supplement state and local medical supplies to ensure patients have access to the resources needed for effective, safe treatments. Currently, the office prioritizes procuring medicines for the stockpile that are effective against potential biothreats, pathogens that can be weaponized to purposefully harm the public. However, not all medically important antibiotics meet this threshold. For example, many antibiotics without biothreat indications underpin the safety of common medical procedures such as chemotherapy and basic surgeries.

Expanding the stockpile would also help reinvigorate the market by giving companies a reliable opportunity to recoup their investments by selling these drugs to the government. This would strengthen the pipeline and incentivize more companies to participate in the market to develop these much-needed drugs.

There also are promising signs that increased funding could become available to procure more antibiotics. The Biden administration’s recently released fiscal year 2022 budget proposal requests $905 million—a $200 million increase over fiscal 2021—to help the stockpile maintain essential medical supplies; some of that increased funding should be dedicated to purchasing more types of antibiotics. This would help protect patients because superbugs are not only dangerous on their own, but also complicate treatment for other infections, such as COVID-19.

Lastly, O’Connell and her team should support legislative measures to strengthen the pipeline and better fight resistance. The bipartisan PASTEUR Act, recently reintroduced in Congress, would create economic incentives to drive development of new antibiotics that could one day prove valuable additions to the SNS.

The nation faces serious challenges as it considers how best to prepare for future pandemics and other public health emergencies. Under O’Connell, ASPR can take significant steps to protect patients and manage the potential harm caused by antibiotic-resistant pathogens before the threat escalates.

Wes Kim works on The Pew Charitable Trusts’ antibiotic resistance project.

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