American Clinical Laboratory Association

Bancroft attorneys Paul D. Clement, Viet D. Dinh, and Jeffrey M. Harris, together with Professor Laurence Tribe of Harvard Law School, represent the American Clinical Laboratory Association (ACLA) in challenging regulatory overreach by the Food and Drug Administration.  For decades, laboratory-developed testing services had been comprehensively regulated by the Centers for Medicare and Medicaid Services pursuant to explicit statutory authority from Congress.  Yet in July 2014, the FDA asserted unprecedented authority to regulate laboratory testing services as “medical devices.”  Under that sweeping interpretation of its authority, FDA would have jurisdiction to impose all manner of burdensome new regulations on laboratory tests.

Bancroft has assisted ACLA in challenging this regulatory overreach.  In January 2015, Bancroft and Prof. Tribe prepared a comprehensive white paper articulating the many legal flaws with the FDA’s position.  Bancroft has also advised ACLA on public relations and government outreach efforts.

ACLA White Paper