New Senate Bill Promotes Antibiotic Development

Kate Johnson

October 21, 2011

October 21, 2011 — The Generating Antibiotics Incentives Now (GAIN) Act, introduced this week by Sen. Richard Blumenthal (D-CT) and Sen. Bob Corker (R-TN), aims to "spur development of new antibiotics to combat the spread of antibiotic-resistant bacteria," according to a press release issued by Sen. Blumenthal.

"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," Sen. Blumenthal said in the statement.

The GAIN Act, authored by Rep. Phil Gingrey, MD (R-GA), was also introduced in the US House of Representatives with bipartisan support on June 15.

"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," said Rep. Gingrey in a statement at that time.

According to Sen. Blumenthal, "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 US each year."

The GAIN Act is designed to "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," said the statement.

The Pew Health Group, an arm of the nonprofit Pew Charitable Trusts, announced its support for the initiative.

"We commend Sen. Blumenthal and Sen. Corker for their leadership and are committed to working with them to pass the GAIN Act," said Sharon Ladin, director of the Pew Health Group's Antibiotics and Innovation Project.

The Pew Health Group noted that movement is urgent because "the antibiotic pipeline is dwindling, and a global crisis looms."

The GAIN Act "seeks to create incentives to encourage the development of products to treat, prevent, detect and diagnose antibiotic-resistant infections," according to a Pew summary. "It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics."

More specifically, the legislation grants an additional 5 years of market protection at the end of existing exclusivity for "qualified infectious disease products." These are defined as antibiotic drugs "for treating, detecting, preventing, or identifying a qualifying pathogen."

It also grants an additional 6 months of exclusivity for drugs for which a companion diagnostic test is cleared or approved.

Finally, the bill designates qualified infectious disease products as eligible for US Food and Drug Administration fast tracking and requires the US Food and Drug Administration to grant priority review to drugs "that are intended to treat, detect, prevent or identify certain drug-resistant infections."

These include resistant gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant S aureus, and vancomycin-resistant Enterococcus, as well as multidrug-resistant gram-negative bacteria including Acinetobacter, Klebsiella, Pseudomonas, and Escherichia coli species and multidrug-resistant tuberculosis.

Among the most pressing concerns about antibiotic resistance is a new highly resistant and contagious strain of Acinetobacter baumannii, according to Sen. Blumenthal's statement.

Infections from this strain increasingly are being seen among troops returning from Iraq and Afghanistan, with 89% of them being resistant to at least 3 classes of antibiotics, and 15% being resistant to all known antibiotics, the statement said.

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