Nooga.com: Sen. Bob Corker's "super bugs" legislation set to become law

Jun 27, 2012

A bill introduced last year by Sens. Bob Corker and Richard Blumenthal, D-Conn., passed as part of a 92-4 Senate vote on an FDA funding bill Tuesday.


After being passed in a House vote last week, the legislation will now head to the desk of President Barack Obama to be signed into law.


The legislation, called the GAIN Act, was introduced by the senators last October and is designed to provide incentives for pharmaceutical manufacturers for the research and creation of innovative antibiotic drugs geared toward thwarting continually evolving bacteria known as "super bugs."


GAIN is an acronym for Generative Antibiotic Incentives Now.


Super bugs, which were responsible for more than 17,000 deaths in the U.S. every year between 1999 and 2005, according to Corker's office, are resistant to traditional antibiotics because of their continual change. Because of the unpredictability, the market for antibiotics used to treat the super bugs isn't as lucrative for drug companies, who often opt to develop lifelong supplements for more static conditions like cholesterol or diabetes.


To encourage the companies to pursue more effective antibiotic remedies, the GAIN Act will allow for the extension of exclusivity—a concept that allows pharmaceutical companies to maintain rights to a particular drug and any intellectual property behind it before other companies can build on their products. The current exclusivity period for antibiotics is five years, a time the senator said would not be long enough for companies to deem their work profitable.

The new law would extend the exclusivity period for antibiotics to 10 years.


In brief remarks on the Senate floor, Corker said the bill would encourage innovation of antibiotics targeting super bugs without costing any federal dollars.


"The GAIN Act is a straightforward, common sense bill that provides market incentives to encourage innovation without putting federal dollars at stake, and it's included in this FDA reauthorization," Corker said. "Antibiotic resistance is a growing issue that we must address now to properly prepare for the future."


Sharon Ladin, director of antibiotics and innovation projects at the Pew Health Group in Washington, D.C., said Corker "played an enormous role" in helping the bill get through Congress. Ladin added that the economic outlook for drug companies wishing to pursue new antibiotics would be better because of the law.


"I think Sen. Corker has an interest in supporting legislation that was going to have broad public health value," Ladin said. "I think he saw this as something that he could get done, be done in a bipartisan way, and have a big impact on the people of Tennessee. And he has received support from hospitals and health care providers in the state who said it was important to them."


Organizations who endorsed the bill included the National Military Vets Alliance, the American Medical Association, and the St. Jude Children's Research Hospital and Children's National Medical Center in Memphis.

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