FDA cracking down on use of petitions to delay generics

FDA released draft guidance Tuesday aimed at reducing the use of 505(q) Citizen's Petitions intended to delay market entry of generic drugs. In a statement, FDA Commissioner Scott Gottlieb said some parties have used the petitions among "anticompetitive techniques."

The agency said while such petitions have rarely succeeded in delaying generic approvals, the burden of reviewing them diverts resources away from pending applications...