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Federal judge relaxes FDA restrictions on drug promotion

The Associated Press
08.03.98

WASHINGTON -- The Food and Drug Administration may not block drug companies from distributing certain information to doctors about unapproved uses of medicines, a federal judge has ruled.

U.S. District Judge Royce Lamberth ruled Thursday that certain FDA restrictions on drug marketing violated First Amendment rights of commercial speech.

"It's a tremendous victory," said Richard Samp of the Washington Legal Foundation, a conservative group that filed the lawsuit, (Washington Legal Foundation v. Michael Friedman). "It means there will be a much freer flow of truthful information."

The controversy began when the FDA received complaints from doctors who discovered that what they thought were independent medical seminars were really sponsored by drug companies which paid speakers to endorse medicines for uses not approved by the FDA.

It is legal for doctors to prescribe any drug on the market however they see fit, but companies can only promote their products for FDA-approved uses. Thus, the FDA said drug companies couldn't promote unapproved uses for drugs under the guise of a medical seminar.

The Washington Legal Foundation sued, also attacking FDA policy that prohibited drug makers from giving doctors reprints of medical studies or textbooks that backed unapproved drug uses.

Meanwhile, Congress last year passed a compromise: Drug companies can give doctors studies printed in quality medical journals about unapproved uses of drugs if they are working to win FDA approval.

Government attorneys were still trying to determine how far-reaching the court ruling is.

"The agency will carefully review the decision and will work closely with the Department of Justice in determining possible courses of action," said FDA Associate Commissioner William Hubbard.


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