FDA paints chaotic off-label picture

WASHINGTON - Confusion over the status of regulations on the dissemination of data about off-label uses of approved products has created a legal limbo in which manufacturers of drugs, biologics and devices are adopting diverse strategies. Some have submitted off-label information to FDA for review and approval prior to dissemination, others have cited a federal judge's ruling as authority for disseminating information with accompanying disclosures, and others are completely ignoring the agency, according to an affidavit filed by the FDA last week.

In July 1998, Judge Royce Lambreth of the U.S. District Court for the District of Columbia ruled that FDA's off-label regulations violate the First Amendment to the U.S. Constitution. Granting summary judgment to the Washington Legal Foundation (WLF), which had launched the suit, he ordered the agency to revise its regulations, basically limiting the restrictions to requirements that the manufacturer's interest in the product be disclosed in material sent to physicians and mandating disclosure that the described use has not been approved by FDA...