ADAPT Act

The Antibiotic Development to Advance Patient Treatment Act (ADAPT) was introduced in the U.S. Congress on December 12, 2013 by Representative Phil Gingrey of Georgia and fifty-two cosponsors. Responding to the lack of financial incentives for drug manufacturers to innovate new antibiotics and the regulatory barriers to their doing so, it proposed an expedited pathway for testing drugs intended for diseases for which no cure yet existed. After it died in committee, a similar version of the Act was re-introduced by Representative John Shimkus of Illinois and his cosponsor Representative Gene Green of Texas. Though this Act likewise failed to make it out of committee, several of its provisions were codified in the 21^st Century Cures Act, which was signed into law on December 13, 2016. These include the expedited testing pathway for new antibiotics and a similar provision for antimicrobial susceptibility tests.

The ADAPT Act aims to fast track the drug development in order to combat the growing public health threat of 'superbugs'. Under this Act, FDA can approve antibiotics and antifungals needed for life-threatening infections based on data from smaller clinical trials.

The CDC will reinforce the monitoring of the use of antibiotics that treat serious and life-threatening infections and the emerging resistance, and make the data publicly available. The FDA antibiotics labeling process, 'Susceptibility Test Interpretive Criteria for Microbial Organisms or 'breakpoints' is also streamlined to allow the most up-to-date and cutting-edge data available to healthcare professionals under the new Act. 

Congress has been urged in 2014 from several parties to aid the development of new drugs via bills such as ADAPT. Allan Coukell, director of drugs and medical devices at The Pew Charitable Trusts, testified in front of the House Committee, in a statement published by Reuters, that "By allowing drug developers to rely on smaller datasets, and clarifying FDA's authority to tolerate a higher level of uncertainty for these drugs when making a risk/benefit calculation, ADAPT would make the clinical trials more feasible."