Judge overturns law regulating drug info

Drug companies now can tell doctors about other uses for their products.

The Associated Press

WASHINGTON -- 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."

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

"We're delighted with (the ruling), of course," said Shawn Gunnarson of the Washington Legal Foundation, a conservative group that had challenged the law. "It makes it very clear that the First Amendment is alive and well."

Peggy Dotzel, FDA acting associate commissioner for policy, said the agency was studying the ruling in order 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 originally were 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.

The FDA argued that its rules don't violate free speech because they allow the companies to distribute the materials under certain conditions, such as disclosing any relationship between the company and researcher, listing other products for the illness in question and providing a list of other articles on the drug.

Lamberth called that argument "preposterous," stating that "the First Amendment is premised upon the idea that people do not need the government's permission to engage in truthful, nonmisleading speech about a lawful activity."

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