New FDA working group to bolster generic competition

FDA Commissioner Scott Gottlieb has created a working group of senior FDA staff who will look for ways to increase generic competition beyond the steps he has already set in motion. His idea is to reinvigorate FDA's enforcement of the Hatch-Waxman Act to ensure there is robust generic competition to branded drugs as soon as patents have expired.

In congressional testimony and at a public meeting in July, Gottlieb said some drug companies are "gaming the system" to maintain sales at premium prices long after generics should have lowered prices. Steps Gottlieb has initiated so far include crafting policies to prevent innovators from using REMS to block generic competition (see BioCentury, June 23). ...