Pew Applauds Congressional Movement Toward New Regulatory Pathway for Antibiotics

On May 21, the U.S. House moved forward with legislation that would help get new, much-needed antibiotics to patients with serious or life-threatening antibiotic-resistant infections.

The Antibiotic Development to Advance Patient Treatment (ADAPT) Act, originally introduced in 2013, has now been included as part of the 21st Century Cures Act, the wide-ranging health care bill just approved by the House Energy and Commerce Committee. This legislation proposes a streamlined approval pathway for new antibiotic drugs targeting seriously ill patients who have few or no other treatment options.

Antibiotic-resistant bacteria, the so-called superbugs that are difficult or impossible to treat with existing medications, continue to emerge and spread at an alarming rate. At the same time, too few antibiotics are reaching patients through our current approval process.

The ADAPT Act, along with companion legislation already introduced in the Senate, would require the Food and Drug Administration to establish a new approval process known as the Limited Population Antibacterial Drug (LPAD) pathway. Both the House and Senate bills would allow FDA approval based on smaller clinical trials for antibacterial drugs that address pressing unmet medical needs, such as multidrug-resistant infections. The LPAD could help lower development costs and make clinical trials more feasible because it is often not possible to develop these drugs using traditional large clinical trials, owing to the limited numbers of patients in whom these infections occur. Importantly, any drug approved under the LPAD pathway must still meet existing FDA standards of evidence for safety and effectiveness.

The bipartisan and bicameral congressional momentum for the LPAD pathway reflects wide support from a large and diverse group of stakeholders, including organizations representing a cross section of the health care community. Pew has joined these organizations in signing a letter of support for the LPAD pathway as an important step in advancing antibiotic development.

While no single policy will address all of the complex challenges to combatting antibiotic resistance, we are encouraged by the bipartisan commitment to advancing LPAD and look forward to continued work with policymakers on this critical public health issue.

Learn more about Pew’s antibiotic resistance project.