Rep. Eshoo and Bipartisan Coalition Introduce Bill to Combat the Rise of Drug-Resistant Infections

Statement

Today, Rep. Anna G. Eshoo (D-Palo Alto) and a bipartisan coalition of Members of the U.S. House of Representatives introduced the Generating Antibiotic Incentives Now (GAIN) Act, to provide incentives for the development of new antibiotics needed to treat new and emerging resistant bugs. The GAIN Act is authored by Congressman Phil Gingrey, M.D. (R-GA) and co-sponsored by Representatives Anna G. Eshoo (D-CA), Gene Green (D-TX), Ed Whitfield (R-KY), Diana DeGette (D-CO), Mike Rogers (R-MI), and John Shimkus (R-IL). The following statements were issued along with the introduction of the bipartisan legislation:

Rep. Anna G. Eshoo (D-CA): "Every day, patients in our country, and around the world, die because they develop infections resistant to existing antibiotics. As bacteria evolve, it's critical that antibiotics stay a step ahead of the problem. This bill encourages companies to develop new antibiotics, an area that's traditionally been unprofitable for most companies and the reason why they are really lacking in our healthcare system. The GAIN Act is a bipartisan approach to stave off a public health crisis and I look forward to its passage into law."

Rep. Phil Gingrey (R-GA): "There are some issues so important they transcend politics-as-usual. Protecting American families from deadly infections is certainly one of them, which is why my colleagues and I are introducing the GAIN Act. With this legislation, we hope to ensure that new drugs will be available to combat the rising numbers of antibiotic-resistant bugs that threaten Americans in hospitals, on the battlefield, in their homes, and in our schools. Health professionals have been sounding the alarm on this problem for over a decade -- a solution to this problem is long overdue."

Rep. Gene Green (D-TX): "To date, antibiotics have been overused and over prescribed. This has resulted in mutating new bacteria with fewer and fewer antibiotics to combat infection. The GAIN Act, by providing innovators with additional data exclusivity, seeks to responsibly spur innovation and increase the number of new antibiotics in the FDA approval pipeline. The growing threat of antibiotic resistance is very disconcerting and an issue Congress must take steps to address before it becomes a full blown public health crisis."

Rep. Mike Rogers (R-MI): "The GAIN Act will encourage the development of next-generation antibiotic drugs to protect public health and our national security," said U.S. Rep. Mike Rogers, MI-08. "It will also ensure that we use our nation's greatest resource -- our own scientists and engineers -- to come up with innovative solutions to reduce antimicrobial resistance."

Rep. Diana DeGette (D-CO): "Amidst growing concerns about antibiotic resistance and its very real threat to the public health, I am proud today to cosponsor the GAIN Act," said Rep. Diana DeGette (CO-1). "We face not only resistance to treatments for the bacterial illnesses we've long confronted, but also the threats of mutations or new illnesses we've yet to encounter. This bill addresses the need for new and innovative antibiotic treatments to better protect our families and the health of the American public as a whole for years to come."

This legislation would provide new incentives for the development of "qualified infectious disease products," or antibiotics, by granting five years of additional data exclusivity to the product developed. Additionally, it would provide six months data exclusivity for products with companion diagnostics, provide priority review by the Food and Drug Administration (FDA), and make products eligible for fast-track designation by the FDA. It would also require a review and possible revising of FDA guidelines regarding clinical trials and other requirements for approval of antibiotic drugs.