ADAPT Act

The Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 was introduced in the U.S. Congress on 12 December 2013.

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.[1][2] 

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."[3]

References

  1. ↑ Press Release (12 December 2013). "Green, Gingrey Introduce ADAPT Act to Safeguard Public Health". U.S .Congress.
  2. ↑ "Antibiotic Development to Advance Patient Treatment Act of 2013" (PDF). U.S. Congress. 12 December 2013.
  3. ↑ Clarke, Toni. "U.S. Congress urged to pass bill to speed development of antibiotics". Reuters. Retrieved 19 September 2014.


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