Washington, DC - Sharon Ladin, director of the Pew Health Group’s Antibiotics and Innovation Project, issued the following statement regarding the Generating Antibiotics Incentives Now (GAIN) Act (H.R. 2182), introduced today by Rep. Phil Gingrey (R-Ga.) and co-sponsored by Reps. Gene Green (D-Texas), Diana DeGette (D-Colo.), Anna Eshoo (D-Calif.), Mike Rogers (R-Mich.), Ed Whitfield (R-Ky.) and John Shimkus (R-Ill.). The bill contains provisions to incentivize the creation of new antibiotics to combat serious drug-resistant infections.
“Antibiotics save millions of lives each year. Yet our current arsenal of these life-saving medicines is dangerously low, tens of thousands of Americans are dying each year from drug-resistant infections and too few new antibiotics are in the pipeline.
“We applaud Representatives Gingrey, Green, DeGette, Eshoo, Rogers, Whitfield and Shimkus for introducing the GAIN Act, a bipartisan bill that addresses market failures that are stifling antibiotic innovation. This legislation represents an important first step.
“We look forward to working with the sponsors of the GAIN Act and their colleagues in Congress—as well as regulators, industry, public health officials, doctors and scientists—to overcome the unique economic, scientific and regulatory challenges facing antibiotics developers and enable them to deliver new, life-saving medicines to the growing number of people who urgently need them.”
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after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
More infoAs 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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