Citizen Petition Regarding the Food and Drug Administration's Policy on Promotion of Unapproved Uses of Approved Drugs and Devices; Request for Comments

概要

The Food and Drug Administration (FDA) is requesting comment on a citizen petition from the Washington Legal Foundation (WLF). The petition requests that FDA withdraw the document entitled, ``Draft Policy Statement on Industry-Supported Scientific and Educational Activities,'' (hereinafter referred to as the draft policy statement) which was published in the Federal Register on November 27, 1992. The draft policy statement was intended to provide guidance concerning educational and scientific activities that may be supported by industry without causing them to be regulated as advertising or promotional labeling. The draft policy statement was intended to facilitate the flow of reliable information about FDA-regulated products. Nonetheless, the petition claims that the draft policy statement and FDA's regulation of the promotion of unapproved uses generally are contrary to the First Amendment's protection of speech and interfere with health care professionals' provision of effective medical care. The petition requests that FDA formally adopt a policy stating that, while drug and medical device manufacturers should not label their products for unapproved uses, they will not be subjec