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Media Institute Urges FDA Not To Appeal Court Decision in WLF Textbook Case

FOR RELEASE: August 5, 1998

Contact: Richard T. Kaplar
The Media Institute


August 5, 1998

The Food and Drug Administration should not appeal a federal court ruling that prohibits the agency from hindering the distribution of medical textbooks and journal articles, The Media Institute urged today.

"It's time for the FDA to defer to the First Amendment," said Institute President Patrick D. Maines.

On July 30, U.S. district court Judge Royce Lamberth ruled that the FDA's policy barring pharmaceutical companies from distributing medical textbooks and journal articles that mention off-label uses of their products was an unconstitutional attempt to restrict commercial speech. The ruling also barred the agency from influencing independent producers of continuing medical education (CME) seminars.

The case, Washington Legal Foundation v. Kessler, had been brought by WLF in 1994 in response to FDA "draft policies" on print distribution and CME dating from 1991.

"What remains deeply troubling is how long the FDA was able to flout constitutional law, first by circumventing administrative procedures and then by using every delaying tactic in the courts," Maines said.

In 1992 the Institute published a book now considered a classic on the topic, Bad Prescription for the First Amendment: FDA Censorship of Drug Advertising and Promotion. In 1994 the Institute assembled a coalition of media and First Amendment groups and filed a friend-of-the-court brief in the WLF case. In addition, Maines has spoken and written extensively on the FDA's textbook and CME policies.

"The court's decision vindicates what we have been saying since the early 1990s," Maines noted today.

The Media Institute is a nonprofit research organization specializing in communications policy and First Amendment issues.