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Press Release
Pew Supports Antibiotics Innovation Bill in Senate
Washington, DC - Sharon Ladin, director of the Pew Health Group’s Antibiotics and Innovation Project, issued the following statement regarding the bipartisan, bicameral Generating Antibiotic Incentives Now (GAIN) Act, introduced today by Sen. Richard Blumenthal (D-Conn.) and Sen. Bob Corker (R-Tenn.). The bill is a companion to H.R. 2182 and contains provisions to incentivize the creation of new antibiotics to combat serious drug-resistant infections.
“We commend Sen. Blumenthal and Sen. Corker for their leadership and are committed to working with them to pass the GAIN Act.
“Drug-resistant infections are a growing threat to the health of all Americans. Unfortunately, economic, regulatory and scientific challenges are stifling antibiotic innovation. New pharmaceuticals cost hundreds of millions of dollars for basic and clinical research, but antibiotics typically produce relatively small revenues, making them less attractive investments than other types of drugs. In addition, clinical studies of these drugs are costly and difficult to conduct.
“The GAIN Act takes an important first step toward overcoming these hurdles by creating economic incentives to spur the development of new antibiotics that we need to treat serious infections and save lives.”
Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
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The lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent.
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As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.
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