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Gingrey: Passage of FDA Reform, GAIN Act “critical” to protecting public health

Washington, May 30 -

Today the House of Representatives passed the bipartisan Food and Drug Administration Reform Act of 2012. This bill reauthorizes a number of provisions in statute which support the critical work of the FDA and ensures patient access to life-saving, life-improving drugs, and medical devices. The legislation included the GAIN Act, authored by GOP Doctors Caucus co-chair Congressman Phil Gingrey, M.D. (R-GA), which aims to spur development of new drugs to treat increasing cases of bacterial infections resistant to conventional antibiotics. The GAIN Act ensures patients have access to life-saving treatments and will decrease the risk of a nationwide, drug-resistant epidemic. In addition to protecting public health, the FDA Reform Act of 2012 also seeks to stem the tide of drug developers, investors, and clinical trials from moving overseas. 

“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 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.’ This legislation will encourage investment in new drug development and I look forward to it being signed into law.”

Last week, the Senate passed the GAIN Act’s companion piece, introduced by U.S. Senators Bob Corker (R-TN) and Richard Blumenthal (D-CT).

“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,” said Blumenthal. “I am thrilled that the House of Representatives passed the GAIN Act today. The GAIN Act is an incredible example of what we can accomplish when we work together in a bipartisan fashion, and I look forward to seeing it signed by the President soon.”

“The GAIN Act has received strong support from both parties and numerous health care stakeholders because it’s commonsense legislation 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. As Dr. William Evans, director and CEO of St. Jude’s Children’s Research Hospital in Tennessee, 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.’”

The bill now awaits the President’s signature.

About Drug-Resistant Bacteria:

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.