Drug Lobbyists: FDA's BPCIA Transition Guide Hurts Access, Competition

Several industry members told FDA that forcing biologics sponsors to withdraw their pending drug applications and resubmit them as biologic license applications when the products transition in 2020 would have significant impact on patient access and healthcare costs. The generic drug lobby called the time period prior to March 2020 a “dead zone” and the brand drug lobby called it a “blackout period” where neither new drug applications nor biologic license applications could be submitted if the agency's proposed interpretation...