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Public Statements

Corker, Blumenthal, Gingrey: FDA User Fee Reauthorization Including GAIN Act to Become Law

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Location: Washington, DC

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 as part of an agreement between the House and Senate to reauthorize Food and Drug Administration user fees. 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. The House-Senate agreement (S.3187), having already been approved by the House, passed the Senate today by a vote of 92 to 4 and now goes to the president to be signed into law.

"Passage of the FDA bill shows that Congress can pass legislation through regular order and produce a good result for the American people. I'm particularly pleased the legislation includes the GAIN Act. Antibiotic resistance is a growing issue that we must address now to properly prepare for the future. As Dr. William Evans of St. Jude in Memphis has said, "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,'" said Senator Corker.

"Very importantly, this historic FDA law includes the GAIN Act, a bipartisan measure key to fighting superbugs that are a health menace in Connecticut and across the country. Incentives for research and development, and fast-track review by the FDA are needed to stop these antibiotic-resistant bacteria and infections like MRSA and E. coli from spreading," Senator Blumenthal said. "A strong bipartisan coalition, combined with support from Connecticut's science and medical community helped me design and successfully advocate for this significant step."

"As a physician for more than 30 years, I understand first-hand the urgent need for innovative, life-saving medical treatments," said Rep. Gingrey. "Unfortunately, the number of new antibiotic drugs approved by the FDA has diminished significantly over the past two decades. If we are to prevent a future public health crisis, we must streamline the FDA regulatory process and ensure the further development of new antibiotics to treat dangerous "superbugs.' The GAIN Act is an important first step in our efforts to encourage investment in new drug development and I look forward to it being signed into law."

The GAIN Act, without putting additional federal dollars at stake, 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).


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