IDSA is making important progress in legislative efforts to promote antibiotic drug development. Reps. Phil Gingrey (R-VA) and Gene Green (D-TX) on Dec. 12 led a bipartisan effort to introduce the Antibiotic Development to Advance Patient Treatment (ADAPT) Act
IDSA worked closely with Reps. Green and Gingrey, who is a physician, to develop this legislation, which is an important successor to the GAIN Act
, introduced by Reps. Gingrey and Green, supported by IDSA, and signed into law in 2012.
The ADAPT Act would advance drug development by establishing a new limited population antibacterial and antifungal drug approval pathway for drugs to treat serious or life-threatening infections where there exists an unmet medical need. IDSA first put forward this concept in 2012, and the ADAPT Act is a result of IDSA’s persistent advocacy on this issue. In a letter
(PDF) to Reps. Gingrey and Green, IDSA President Barbara Murray, MD, FIDSA, expressed IDSA’s support of the legislation and highlighted one area in which the bill could be strengthened. IDSA’s Take Action
web page includes an action alert that makes it easy to email your congressional representatives and urge them to co-sponsor and strengthen the ADAPT Act.
The proposed legislation would speed patient access to important antibacterial and antifungal drugs by allowing them to be approved based upon smaller, more rapid clinical trials. 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.
Any drug approved under this new pathway would still need to meet the Food and Drug Administration’s (FDA) standards of evidence for safety and effectiveness for the limited indicated population. IDSA expressed to the sponsoring legislators the importance of communicating to the health care community the need to use these drugs prudently. Specifically, IDSA appreciates the bill’s current provisions aimed at this goal, but is also recommending that drugs approved under this new pathway be marked with a special logo to more clearly differentiate them from traditional antibiotics.
In a report
issued last April, IDSA identified only seven new drugs in development for the treatment of infections caused by multidrug-resistant Gram-negative bacilli, and none of these drugs addresses the complete set of needs associated with these infections. The ADAPT Act would help to address this need as well as the increasing antibiotic threats outlined in the Centers for Disease Control and Prevention (CDC) report
(PDF) issued in September 2013.
Additional co-sponsors of the legislation are: Reps. Marsha Blackburn (R-TN), G.K. Butterfield (D-NC), Eliot Engel (D-NY), Anna Eshoo (D-CA), Morgan Griffith (R-VA), John Shimkus (R-IL), and Ed Whitfield (R-KY).
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