GAIN Is Great: Now Who Gets the Benefits?
This article was originally published in RPM Report
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?
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.
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.