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Media Institute Files Comments with the FDA on First Amendment Issues

FOR RELEASE: September 10, 2002

Contact: Richard T. Kaplar
The Media Institute


Washington, Sept. 10, 2002 - The Food and Drug Administration should heed recent federal court rulings and stop infringing on the First Amendment rights of pharmaceutical companies, The Media Institute stated in comments filed today with the FDA.

The Institute noted that the FDA's unique authority to regulate both a pharmaceutical product itself and the advertising for that product had, until very recently, caused the FDA to act as if it were exempt from the First Amendment in its regulation of speech about drug products.

"Drug makers' speech about their products - while critical to the safe and efficacious use of those products - is not a unique category of expression beyond the reach of the First Amendment," the Institute said.

The FDA's expansive control over promotional activity makes companies unwilling to antagonize the agency over questions of advertising and labeling lest the FDA retaliate by slowing the approval process for a company's new drugs, the Institute said. The FDA must take affirmative steps to dispel the perception that drug companies are punished for exercising their First Amendment rights to challenge restriction on their speech, the Institute argued.

"Regulation through intimidation, using extra-legal 'informal' or 'voluntary' tactics, must become a thing of the past," the Institute also said. The Institute urged the FDA to rely strictly on established administrative and statutory rulemaking procedures.

The comments were filed by the Institute in response to a request by the FDA for comment on the First Amendment issues.

The Media Institute is a nonprofit research foundation specializing in communications policy and First Amendment issues. For more information visit the Institute's Web site at