Blumenthal, Corker, Gingrey Praise Inclusion Of Gain Act In Discussion Draft Of FDA User Fee Reauthorization Bill

(Washington, DC) – U.S. Senators Richard Blumenthal (D-CT) and Bob Corker (R-TN) and U.S. Representative Phil Gingrey (R-GA) praised inclusion of the GAIN Act (S.1734) in a discussion draft of the Food and Drug Administration User Fee reauthorization bill released today by the Senate Health, Education, Labor and Pensions Committee.  The GAIN Act, introduced by Blumenthal and Corker 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.

“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 continued progress of the GAIN Act, with bipartisan, bicameral support,” Senator Blumenthal said.

“While I will carefully consider the overall FDA bill on its own merits, I’m pleased the GAIN Act is advancing in the process and am hopeful growing support for the act among both parties in Congress will allow it to become law,” 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.” “The United States is facing a public health crisis in the near future if we are unable to encourage new drug development,” said Representative Gingrey. “We experienced how such a crisis can impact our most vulnerable patients during the H1N1 scare. We cannot afford to be caught defenseless again.  The GAIN Act is an important step in our efforts to protect patients from new and emerging forms of resistant bacteria and I commend the Senate for their efforts.”

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), Bennet (D-CO), Casey (D-PA), Chambliss (R-GA), Coons (D-DE), Hatch (R-UT), Isakson (R-GA), Kerry (D-MA), and Roberts (R-KS).

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