JUDGE LOOSENS FDA RESTRICTIONS ON DRUG PROMOTION

WASHINGTON (AP) - 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 free commercial speech.

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

The controversy began when FDA received complaints from doctors that what
they thought were independent medical seminars were really sponsored by
drug companies that paid speakers to endorse medicines for uses not
approved by 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, FDA said drug companies couldn't promote unapproved 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.

Checked-by: Mike Gogulski