FDA May Be Facing Court Fight if It Oversteps Its Authority

The FDA could be opening itself to litigation if it oversteps regulatory bounds set by Congress. FDA Chief Counsel Ralph Tyler surprised some device attorneys when he announced that the agency may try to regulate in ways not explicitly allowed by Congress. While the expense and repercussion of fighting the agency can be intimidating, industry may be willing to draw a hard line to stop the FDA from exceeding its authority, Jennifer Bragg, partner at Skadden, Arps, Slate, Meagher & Flom, said.
Devices & Diagnostics Letter