Congress hasn’t made any progress on drug pricing legislation, but that hasn’t stopped the government from acting. Now, FDA Commissioner Scott Gottlieb has unveiled yet another move to step up competition in the generics business.
After previously announcing several strategies to bring copycat drugs to market more quickly, Gottlieb now says the agency will prioritize applications for generics that could launch immediately after a first-to-market copy loses its 180-day exclusivity.
Though the first generic tends to be cheaper than the brand, the real pricing relief comes after multiple copies launch. Under generic approval rules, the first company to file for FDA approval gets a 180-day lock on the market, and that means the pricing battle waits till that period expires. Gottlieb wants to make sure the competition doesn’t wait further, by lining up other copies for approval.
Written by Eric Sagonowsky
