Pressing First Amendment against FDA

WASHINGTON - The Washington Legal Foundation (WLF) has filed what are likely to be its final arguments in its federal court action seeking to overthrow on free speech grounds the FDA's rules governing the distribution of off-label use of approved drugs and biologics.

In its memorandum filed last week with the U.S. District Court for the District of Columbia, WLF asked Judge Royce Lambreth to hold invalid the off-label dissemination provisions of the FDA Modernization Act (FDAMA) and to constrain the agency's implementing regulations to those that conform to the narrow limits described in his August 1998 order. In that ruling, which preceded the FDAMA law, Lambreth ruled that FDA's off-label regulations violated the First Amendment to the U.S. Constitution...