Anti-Infective Incentives: GAIN, LPAD Won’t Be Enough HHS-Commissioned Report Finds
This article was originally published in RPM Report
The continuing government interest in incentives for antibacterial development got a boost from an unexpected quarter in June. A report commissioned by HHS calls for a broad package of incentives to stimulate continued investment in new anti-infectives.
You may also be interested in...
There are two antibiotic incentive bills vying for attention in Congress. One is a follow-on to the popular GAIN Act; the other takes a new path – creating generous reimbursement formulas to help the next wave of anti-infectives find a successful niche in hospital market.
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?
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.