GAIN Is Great: Now Who Gets the Benefits?
This article was originally published in RPM Report
Executive Summary
Congress is set on enacting a package of antibiotic development incentives—but needs to sort out how best to define the targets.
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In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?
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Congress is on the verge of enacting important new incentives for antibiotic development. At the same time, a federal court ruling on Vancocin generic approvals underscores the importance of doing things the right way.
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The Infectious Diseases Society of America’s “Special Population” approval mechanism has proponents within FDA and industry. That makes it look like a good balancing proposal to complement the market incentives for anti-infectives being pushed under the GAIN Act add-on to PDUFA V. There is one big hurdle, however: GAIN’s major legislative proponent, Rep. Phil Gingrey (R-GA) does not like the limitations on use post-approval.