FDA Told Not to Block Drug Data

The Food and Drug Administration may not block pharmaceutical companies from distributing medical information to doctors about unapproved uses for their products, a federal judge ruled Thursday.

In a potentially far-reaching decision about the powers of the FDA to restrict 1st Amendment rights, U.S. District Judge Royce C. Lamberth ruled that the agency’s ban on the distribution of scientific journal articles and textbooks to doctors violates constitutional protections for commercial speech.

“It’s a very significant decision,” said Dan Troy, an attorney whose firm represented the Washington Legal Foundation, a free-market-oriented Washington advocacy group that filed a lawsuit over the issue.

Under the ruling, the FDA may not restrict the distribution of scientifically rigorous material on unapproved uses.

Once a drug or medical device is approved for one purpose--say, treating ovarian cancer--it can legally be used for any other purpose. FDA officials argued that the rules are necessary to ensure that companies do not promote products by providing incomplete or biased information, or gain approval for a drug for a very narrow use and then promote other uses through the distribution of favorable scientific information.

The Clinton administration is likely to appeal the ruling.