Gingrey, Corker, Blumenthal Praise Senate Committee 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. Representative Phil Gingrey, M.D., (R-GA) and U.S. Senators Bob Corker (R-TN) and Richard Blumenthal (D-CT) praised committee passage of the GAIN Act (S.1734) as part of the Food and Drug Administration User Fee reauthorization bill, which was reported out of the Senate Health, Education, Labor and Pensions Committee today. 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.
“While I will carefully consider the overall FDA bill on its own merits, I’m pleased the GAIN Act is building momentum and has moved one step closer to hopefully becoming law thanks to growing support among both parties in Congress,” Senator Corker said. “Drug-resistant infections pose an increasing threat to public health in Tennessee and throughout the country. The GAIN Act, without putting additional federal dollars at stake, provides meaningful incentives to aid development of new antibiotics in a diminishing segment of the drug market that will help save lives and reduce health care costs.”
“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. I applaud the progress of the GAIN Act and will continue the fight for full passage.” Senator Blumenthal said.
“As a physician Member of Congress, I understand firsthand how the lack of innovation in developing new medicines could result in a public health crisis. The GAIN Act is an important step toward ensuring patients have access to life-saving antibiotics,” Representative Gingrey said. “I am pleased to see the Senate take action and commend Sens. Corker and Blumenthal for their leadership on this issue.”
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), Begich (D-AK), Bennet (D-CO), 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).