Dead Zone: Are Your Biological Products Ready for FDA’s Regulatory Transition?

摘要

On March 23, 2020, hundreds of approved and pending applications for biological products will face a regulatory transition as the U.S. Food and Drug Administration (FDA) implements the "deemed to be a license"provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). On that date, FDA will replace all approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for biologics with biologic license applications (BLAs) or abbreviated biologic license applications (aBLAs), remove these applications and their patents from the FDA's Orange Book, and largely extinguish the products' regulatory exclusivities. FDA will also reject all pending NDAs and ANDAs for biologies, requiring their resubmission as BLAs or aBLAs. Pharmaceutical companies and industry organizations have responded that these actions would constitute unlawful government takings and cause a regulatory dead zone wherein companies cannot gain FDA approval for follow-on biologies through any type of application. Despite guidance from FDA, significant uncertainty remains for pharmaceutical companies regarding their approved and pending applications and associated patent litigations. This article introduces the law underpinning FDA's regulatory transition, discusses FDA's interpretation of that law, and identifies issues that pharmaceutical companies should be considering now.