Corker, Blumenthal, Gingrey Praise Senate Passage of GAIN Act in FDA User Fee Reauthorization Bill
GAIN Act Encourages Development of New Antibiotics to Treat Rising Cases of Drug-Resistant Infections
U.S. Senators Bob Corker (R-TN) and Richard Blumenthal (D-CT) and U.S. Representative Phil Gingrey, M.D., (R-GA) today praised Senate passage of the GAIN Act (S.1734) as part of the Food and Drug Administration User Fee Reauthorization bill. The GAIN Act, introduced by Corker and Blumenthal in October, and its companion, introduced by Representatives Gingrey and Diana DeGette (D-CO) in the House of Representatives, aim to spur development of new drugs to treat increasing cases of bacterial infections resistant to conventional antibiotics. Next week the House of Representatives is expected to consider its version of the FDA reauthorization bill, which also includes the GAIN Act.
“The GAIN Act has received strong support from both parties and numerous health care stakeholders because it is a commonsense bill that provides market incentives to encourage innovation without putting federal dollars at stake,” Senator Corker said. “Antibiotic resistance is a growing issue that we must address now to properly prepare for the future. Dr. William Evans, director and CEO of St. Jude’s in Tennessee, recently wrote a letter supporting this bill, saying ‘We don’t want to find ourselves in a situation in which we’ve been able to save a child’s life after cancer diagnosis only to lose them to an untreatable multidrug resistant infection.’”
“This effort is key to fighting superbugs, a health menace in Connecticut and across the country. Incentives for research and development, and fast track FDA review, are needed to stop these antibiotic-resistant bacteria and infections from spreading,” Senator Blumenthal said. “Senate passage of the GAIN Act exemplifies the progress we can make on key issues when working in a bipartisan fashion. I applaud the Senate passage of the GAIN Act, and urge swift action by the House of Representatives so this bill can become law.”
“As a physician Member of Congress, I understand the critical need for innovative new medicines to combat these ‘superbugs,’" said Rep. Gingrey. "In order to prevent a future public health crisis, my House and Senate colleagues have created the bipartisan GAIN Act to ensure patients have access to life-saving treatments and to decrease the risk of a nationwide, drug-resistant epidemic. In addition to protecting public health, this legislation also seeks to stem the tide of drug developers, investors, and clinical trials from moving overseas. I commend my Senate colleagues for the efforts today.”
The GAIN Act provides incentives to increase the commercial value of innovative antibiotic drugs and streamlines the regulatory process so that pioneering infectious disease products can reach patients. Antibiotic-resistant infections are on the rise, causing nearly 90,000 deaths each year, disproportionately affecting children and the elderly and leading to $26 billion in extra costs annually to the U.S. health care system.
Antibiotic resistant “superbugs” have been increasing over the last decade, with the rate of antibiotic-resistant Staph infections approaching 50 percent. Currently, antibiotic-resistant MRSA infections are responsible for over 17,000 deaths in the U.S. each year, and between 1999 and 2005, MRSA infection-related hospitalizations double from around 127,000 to 278,000. The Centers for Disease Control and Prevention found that late-onset MRSA infections increased 300 percent in neonatal intensive care units ICUs from 1995-2004, increasing average stay by 40 days at an increased cost of $160,000 per patient.
Drug-resistant infections have increasingly affected troops returning from Iraq and Afghanistan, as many of them have been exposed to a new, highly-resistant and contagious strain of Acinetobacter (Iraqibacter) bacteria. Approximately 3,300 service members were treated for drug-resistant Acinetobacter between 2004 and 2009. Among these cases, 89 percent are resistant to at least three classes of antibiotics and 15 percent are resistant to all forms of treatment.
The GAIN Act has been endorsed by 53 groups, including the National Military Vets Alliance, American Medical Association, St. Jude Children’s Research Hospital and Children’s National Medical Center.
Cosponsors of the GAIN Act in the Senate, in addition to Senators Blumenthal and Corker, include Senators Alexander (R-TN), Ayotte (R-NH), Begich (D-AK), Bennet (D-CO), Carper (D-DE), Casey (D-PA), Chambliss (R-GA), Coons (D-DE), Hatch (R-UT), Isakson (R-GA), Kerry (D-MA), Roberts (R-KS) and Tester (D-MT).