FDA Antibiotics Incentives List Goes Beyond GAIN Act
This article was originally published in Pharmaceutical Approvals Monthly
The agency’s proposed rule on qualifying pathogens is longer than the initial legislative list, but industry still awaits regulations on the law’s exclusivity bonus, which are only achieved through a separate qualified disease product designation.
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Both FDA and Congress are taking interest in combating antibiotic resistance, but FDA likely has more power to make headway in the near term, even as industry remains somewhat wary of that particular agenda item.
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?
PhRMA and GPhA exchange unpleasantries over the legislative pay-for; FDA offers a compromise track-and-trace program that would use the industry proposal as a starting point; structure of antibiotic incentives still unresolved.