Suit to Test Rights of Physicians to Receive Info on Off-Label Drug Use

May 1, 1995

WASHINGTON--The Washington Legal Foundation (WLF), a public interest group, has claimed that the FDA violated the First Amendment rights of physicians by denying them access to information about the off-label use of certain oncologic drugs.

WASHINGTON--The Washington Legal Foundation (WLF), a public interestgroup, has claimed that the FDA violated the First Amendment rightsof physicians by denying them access to information about theoff-label use of certain oncologic drugs.

WLF's suit arises from an action taken by the FDA that preventedBristol-Myers Squibb Co.from giving physicians complimentary copiesof The Chemotherapy Sourcebook, edited by Michael Perry, and chaptersfrom Cancer: Principles and Practice of Oncology, by Vincent DeVita,Samuel Hellman, and Steven Rosenberg.

Federal Judge Royce Lamberth denied the FDA's motion to dismissthe suit, thus clearing the way for a trial, which will be thefirst constitutional test of the agency's criteria to discouragewhat it views as improper promotion of drugs by means of distributionof legitimate medical educational material.