JUDGE OVERTURNS LAW RESTRICTING DRUG INFORMATION GIVEN TO DOCTORS

WASHINGTON (AP) -- A federal judge on Wednesday struck down as
unconstitutional a law allowing the government to restrict information drug
companies can give doctors about unapproved uses of medicines.

U.S. District Judge Royce Lamberth ruled that the Food and Drug
Modernization Act illegally restricts the free speech of drug companies. He
termed government arguments defending the limits "preposterous."

"This is a major victory for drug companies," said analyst Hemant Shah,
with HKS & Co. in Warren, N.J.

The Food and Drug Administration severely limits what drug companies can
say about their medicines beyond the uses approved by the agency. However,
doctors can prescribe FDA- approved drugs for any use they deem proper.

Lamberth last year struck down FDA guidelines for drug companies, but
similar restrictions were included in the FDA Modernization Act, which he
overturned Wednesday.

"It makes it very clear that the First Amendment is alive and well," said
Shawn Gunnarson of the Washington Legal Foundation, a conservative group
that challenged the law.

Peggy Dotzel, FDA acting associate commissioner for policy, said the agency
was studying the ruling to prepare an appropriate response.

In question is the distribution of research reports and medical journal
articles focusing on using drugs for illnesses other than the ones they
were originally approved for.

Many drugs have more than one use and doctors often learn of such
"off-label" uses through such studies.

But the FDA had sought to restrict drug companies from promoting their
products by distributing these reports or holding seminars about the
studies, contending that the companies might stress only the benefits of
their products and not balance that with any reports or problems.