T he FDA a drug's efficacy, omission or minimization of risk information, inappropriate use of reminder advertising, and off-label representations. In 2007, a new FDA Administration Act added certain additional regulations for DTC, including a requirement that print advertisements contain a statement encouraging the reporting of adverse events by telephone or online. The new Act also added a requirement that safety and effectiveness information should appear in "a clear, conspicuous and neutral manner," as well as providing significant monetary civil penalties for violations. Due to the continued intense scrutiny of DTC by certain members of Congress and FDA, most companies voluntarily submit DTC programs for FDA review in advance of broadcast. Companies engaging in DTC and their agencies should closely monitor developments in this highly volatile area. The Off-Label Discussion vs Off-Label Use Paradox Communication about a drug product by a manufacturer for a use, including dosage information, that is not included in the drug's labeling is considered to be off-label, and, therefore, a violation of the Act. A regulatory paradox exists, however, in that, once a drug is approved as safe and effective for any condition, physicians may discuss its uses beyond the approved labeling, while a drug's manufacturer is forbidden to communicate about any unapproved uses except under very limited circumstances. Since this kind of discussion in professional settings is an important part of the advancement-of-science dialog, and is permissible in activities that are independent of a supporting company's influence, the debate over what kind of discussion is or is not permissible continues. For example, unsolicited 65
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