Law Limiting Drug Reports Struck Down

A federal judge on Wednesday struck down as unconstitutional a law allowing the government to restrict information that 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 Hemant Shah, an analyst 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 rules for drug firms, but similar restrictions were also 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 1st Amendment is alive and well.”

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 learn of these “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 of problems.