WLF claims victory in First Amendment case

Medical Marketing and Media, Mar 2000

Washington Legal Foundation says it has won a complete victory in its First Amendment case over dissemination of off-label drug use information after a January 10 hearing before the U.S. Court of Appeals. According to the WLF, the FDA told the court it no longer had a policy against dissemination of such information.

WLF Chief Counsel Richard Samp said that former FDA Deputy Commissioner for Policy and now Justice Department Attorney William Schultz told the judges that the FDA reserves the right to decide on a case-by-case basis if a manufacturer has misbranded a drug or created a new, unapproved drug through improper communication about off-label use, but has withdrawn the guidelines that had been issued and has not replaced them with anything.