Analysis

Bipartisan Momentum Grows for the Limited Population Antibacterial Drug Pathway

On June 3, Representatives John Shimkus (R-IL) and Gene Green (D-TX) introduced the Antibiotic Development to Advance Patient Treatment (ADAPT) Act as a stand-alone bill in the U.S. House, adding to the bipartisan, bicameral momentum on Capitol Hill to establish a new regulatory pathway to approve much-needed antibiotics.

As the threat of antibiotic resistance continues to rise, this legislation would help make the development of new antibiotics more scientifically and economically feasible. The bill mirrors the ADAPT provisions included in the 21st Century Cures Act, a wide-ranging health care bill that was approved by the House Energy and Commerce Committee on May 21.

Today the antibiotic pipeline is dwindling, in part due to the challenges of identifying and enrolling patients with highly resistant bacterial infections in clinical trials. These challenges can make it impossible to conduct traditional, large clinical trials of new antibiotics aimed at treating these specific populations.

To address this, the ADAPT legislation in the House, as well as a companion bill in the Senate—the Promise for Antibiotics and Therapeutics for Health (PATH) Act—would create a Limited Population Antibacterial Drug (LPAD) approval pathway. LPAD’s streamlined process would require antibacterial drugs that treat serious or life-threatening infections to meet the same safety and efficacy standards as any other drug, but it would allow these drugs to be approved based upon smaller clinical trials.

ADAPT’s reintroduction is the latest example of the growing commitment to address the issue of antibiotic resistance. We are encouraged to see LPAD legislation advancing in Congress and look forward to ongoing collaboration with the many diverse stakeholders who share Pew’s sense of urgency on the issue of antibiotic resistance.

Learn more about Pew’s antibiotic resistance project.

Media Contact

Heather Cable