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THE US Food and Drug Administration (FDA) has indefinitely postponed the publication of its long-awaited final policy statement on industry-supported scientific and educational activities.
The FDA has delayed issuing its final guidelines—which were supposed to be published by the end of 1993—in order to answer a "civil petition" filed by a "pro—free enterprise" group that is challenging the agency's legal authority to regulate the speech of pharmaceutical and medical device manufacturers.
The Washington, DC—based group, called the Washington Legal Foundation, is asking the FDA to cease "violating the First Amendment rights" of physicians and patients who have an urgent need for timely information about these products.
The foundation's petition, filed on October 22, asks the FDA "to withdraw its draft policy ["Draft Policy on Industry-Supported Scientific and Educational Activities," Federal Register. November 27,1992] and to refrain from taking any enforcement action against manufacturers that sponsor scientific or educational activities or
Skolnick AA. Pro-Free Enterprise Group Challenges FDA's Authority to Regulate Drug Companies' Speech. JAMA. 1994;271(5):332-335. doi:10.1001/jama.1994.03510290014005