Senators Richard Blumenthal (D-CT) and Bob Corker (R-TN) introduced the Generating Antibiotic Incentives Now (GAIN) Act (S. 1734), bipartisan legislation to spur development of new antibiotics to combat the spread of antibiotic resistant bacteria. Senators Blumenthal and Corker were joined by Senators Bennet (D-CO), Hatch (R-UT), Casey (D-PA), Coons (D-DE), and Alexander (R-TN)
Background
In a press release announcing the legislation, Senator Blumenthal noted that, “While antibiotics are widely used by doctors to treat common infections, an increasing number of strains of bacterial infections are immune to existing antibiotics.” Blumenthal added that, “Antibiotic-resistant infections are on the rise, causing tens of thousands of 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 on the rise for the last decade, with the rate of antibiotic resistant Staph infections approaching 50%. Currently, antibiotic-resistant MRSA infections are responsible for over 17,000 deaths in the U.S. each year.
Blumenthal said, “Superbugs or mutant germs resistant to present antibiotics are a growing public health horror – now targeted through this bipartisan proposal to speed creation and approval of new drugs against them. The threat of these new resistant bacterial infections, particularly threatening to children, seniors, and our returning troops, requires innovative antibiotics.”
The issue increasingly affects troops returning from Iraq and Afghanistan, as many of them have been exposed to a new, highly-resistant and contagious strain of Acinetobacter bacteria – 89% of infections caused by mutant strains of Acinetobacter are resistant to at least three classes of antibiotics and 15% are resistant to all forms of treatment.
GAIN Act
To address this issue, the GAIN Act will provide incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process so that pioneering infectious disease products can reach patients. “Incentives for research and development and fast track FDA review are needed to stop these bacteria and infections from spreading,” Blumenthal asserted.
The bill would extend the exclusivity period for new qualified infections disease products by five (5) years. This extended period will be in addition to any extension for pediatric exclusivity. The legislation would not apply to supplement applications for presently approved drugs, a change that results in a new indication, or a modification to a structure of the product. The bill would also give a product an extended 6 months of exclusivity if the sponsor or manufacturer identifies a companion diagnostic test.
The bill instructs the Secretary of the Department of Health and Human Services (HHS) to create regulations to implement this legislation. The legislation sets out specific definitions of which products will qualify for the extended exclusivity period. If a product is determined to fall within the recognized category, the HHS Secretary will have the discretion to give it priority review.
Additionally, the legislation asks the Comptroller General to conduct a study on the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. It would also instruct the Secretary to review guidelines for conducting clinical trials for antibiotics drugs and revise them as necessary.
The bill was referred to the Senate Health, Education, Labor and Pensions (HELP) Committee. The companion House Bill, H.R. 2182, was introduced back on June 15th, by Phil Gingrey (R-GA) and Diana DeGette (D-CO), and has nineteen (19) co-sponsors. The House bill was referred to the House Energy and Commerce Committee, Subcommittee on Health.
“Drug-resistant infections in Tennessee and across our country are posing an increasing threat to public health, and the federal government can play a constructive role in helping spur innovation of new drugs for treating these conditions. Without putting any federal dollars at stake, our bill provides meaningful market incentives to encourage development of new antibiotics that will help save lives and reduce health care costs,” Corker said. “By strengthening this segment of the market that currently has only a handful of new drugs in the pipeline, we can help ensure Americans at home and our troops abroad have access to treatments capable of combating these deadly infections.”
Sharon Ladin, Director of the Pew Health Group’s Antibiotics and Innovation Project commended Senators Blumenthal and Corker for their bipartisan leadership. She noted how, “The bill creates incentives to spur antibiotic innovation and brings us one step closer to delivering new, life-saving medicines to the growing number of Americans who urgently need them.”
The GAIN Act has been endorsed by 39 groups, including the National Military Vets Alliance, American Medical Association, St. Jude Children’s Research Hospital, and Children’s National Medical Center.