Monday, August 3, 1998
WASHINGTON - In a strongly worded rebuke of the FDA, a U.S. District Court judge has virtually thrown out the agency's current policies on the dissemination of information about off-label indications for drugs and devices. According to Washington regulatory experts, the ruling also casts doubt on the constitutionality of FDA's plans to enforce the most restrictive information dissemination provisions of the Food and Drug Administration Modernization Act (FDAMA).
Judge Royce Lamberth of the U.S. District Court for the District of Columbia last week ruled against FDA in a case brought against the agency by the Washington Legal Foundation (WLF). WLF is a Washington-based advocacy group dedicated to scaling back the scope of government regulations.