Innovative legislation will encourage antibiotic development and address growing threat
Today, Representatives Gene Green (D-TX) and Phil Gingrey, M.D. (R-GA) introduced the Antibiotic Development to Advance Patient Treatment Act (ADAPT) of 2013. This legislation is a successor to the GAIN Act, introduced by Green, Gingrey and others, and signed into law last year. The ADAPT Act advances drug development in order to combat the growing public health threat of “superbugs,” which the Center for Disease Control (CDC) warned of earlier this year.
“I am proud to be joined by health policy leaders from both sides of the aisle in introducing this important bill, especially my friend Representative Phil Gingrey”, Green said. “For decades, antibiotics have been taken for granted, but their effectiveness is waning and the pipeline for new drugs is running dry. We need to invest in new, effective antibiotic therapies in order to combat serious and life-threatening drug-resistant infections. The ADAPT Act, will build on the success of the GAIN Act, and serve as the next important step in advancing the development of new antibiotics.”
Representative Gingrey said, “Since the GAIN Act was signed into law, it has played an important role in restoring antibiotic development. The ADAPT Act is an important next step in the effort to fight antimicrobial resistance, and I’m grateful for Congressman Green’s and my other colleagues’ efforts on this legislation. As a physician for more than 30 years, I understand the critical need for life-saving medical treatments. The ADAPT Act provides incentives for investment and innovation and is another step forward in developing treatments for patients with antibiotic-resistant infections.”
The bipartisan legislation is cosponsored by Representatives G.K. Butterfield (D-NC), Marsha Blackburn (R-TN), Diana DeGette (D-CA), Eliot Engel (D-NY), Anna Eshoo (D-CA), John Shimkus (R-IL) and Ed Whitfield (R-KY).
About the legislation
The ADAPT Act of 2013 is the successor to the GAIN Act and advances drug development in three ways:
1.) Develops a new, accelerated pathway for antibiotics and antifungals
This pathway provides for FDA-approval of drugs in order to treat emerging threats in limited and specific patient populations.
2.) Strengthen resistance monitoring by the CDC
The CDC will also monitor use of antibiotics to treat serious and life-threatening infections and make this data publically available to providers, hospitals, and academics.
3.) Update Susceptibility Test Interpretive Criteria for Microbial Organisms or “breakpoints.”
The ADAPT Act streamlines the antibiotics labeling process at the FDA to ensure up-to-date and cutting-edge data is available on drug labels.