Green, Gingrey Introduce ADAPT Act to Safeguard Public Health
(WASHINGTON, D.C.) – Reps. Gene Green (D-TX), Phil Gingrey, M.D., (R-GA), G.K. Butterfield, (D-NC), Marsha Blackburn (R-TN), Diana DeGette (D-CO), Morgan Griffith (R-VA), Eliot Engel (D-NY), Anna Eshoo (D-CA), John Shimkus (R-IL), and Ed Whitfield (R-KY) today introduced The Antibiotic Development to Advance Patient Treatment (ADAPT) Act 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.
Rep. Gene Green: “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. 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.”
Rep. Phil Gingrey, M.D.: “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.”
Rep. Eliot Engel: “Antibiotic resistance is a serious and growing threat in the United States and across the world. This important legislation gives the Food and Drug Administration the ability to quickly approve medications specifically designed to treat drug resistant bacteria. Having actively worked for years to stop the spread of drug-resistant tuberculosis and having seen its tremendously damaging impact, it is important to give the FDA another tool in the fight to treat Americans stricken by these dangerous “superbugs.”
Rep. Anna Eshoo: “This bill is an important next step in in our effort to address antibiotic resistance. Patients are in need of new drugs to treat increasingly common infections and it’s critical that we stay a step ahead of the next drug-resistant threat. The ADAPT Act will help us get there.”
Rep. John Shimkus: “This bipartisan group of members recognized the need to get more life saving antibiotics available to the public and helped accomplish that goal by getting the GAIN Act included in law. GAIN 2.0 looks to build on the successes we have already seen as a result of our previous efforts by providing a expedited pathway at FDA for approval of certain antibiotics while at the same time gathering valuable information on the resistance of these drugs and how they are being used.”
Rep. Morgan Griffith: “I believe very strongly that, when battling deadly diseases, patients and their physicians need more choices. Our great nation boasts an array of companies and individuals that are working hard to develop new treatments and therapies. The ADAPT Act will further innovation, and ultimately will provide new, antibiotic options in the fight against superbugs.”
Rep. G.K. Butterfield: “The CDC has confirmed that new treatment options are critical to combating drug resistant infections. The ADAPT Act will help to speed new drug treatments to market for people suffering from life-threatening infections. I am proud to join my colleagues in introducing this bill that will help to safeguard the American public.”
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: Strengthens 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. Updates 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 to healthcare professionals.