WASHINGTON — Last week, more than 30 organizations — including the American Medical Association, Infectious Diseases Society of America and Pew Charitable Trusts — urged Congressional leaders to strengthen the labeling requirements for drugs approved under the proposed Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) limited population approval pathway, which will streamline regulatory approval for antibiotics.
On December 12, a group of bipartisan lawmakers led by Reps. Phil Gingrey, R-Ga., and Gene Green, D-Texas, introduced H.R. 374. If enacted, the ADAPT Act would amend the law to create a pathway for the prompt approval of antibacterial drugs.
"The ADAPT Act will build on the success of the Generating Antibiotic Incentives Now Act by allowing antibacterial drugs to treat serious or life-threatening infections to be approved based upon smaller clinical trials," medical organization coalition wrote in a letter to Reps. Gingrey and Green. "It is often not feasible for these drugs to be developed using traditional, large clinical trials due to the limited numbers of patients in whom these infections currently occur."
The organizations recommended the drugs include a prominently placed visual element, such as a logo, on their label to clearly indicate to the healthcare community that they are approved for a limited population and must be used prudently.