United States v. Rx Depot, Inc.
- Case Date: 5/11/2005
- Project Name: Health Care Project
On February 22, 2006, the U.S. Court of Appeals for the Tenth Circuit in Denver declined an opportunity to prevent FDA from exercising enforcement powers that the evidence suggests were never delegated to it by Congress. The court's decision, affirming FDA's authority to seek a massive damage award against an internet pharmaceutical distributor, was a setback for WLF, which had filed a brief urging the court to deny FDA that authority. In its brief, WLF argued that FDA has no power to seek disgorgement or restitution from companies alleged to have violated federal drug laws. WLF argued that Congress has spelled out precisely what enforcement powers it has given to FDA, and that disgorgement and restitution are not among them. WLF argued that FDA, during its history, never asserted a right to seek disgorgement; WLF charged that FDA only recently began asserting that power, to have a big club with which to intimidate manufacturers who might otherwise seek to challenge FDA.
More Information and Downloads:
5/11/2005: Download the Brief
Litigation Update: Court Declines to Rein in FDA's Enforcement Powers
Press Release: Court Urged To Rein In FDA's Enforcement Powers