Consistency With Approved Labeling All prescription drug promotion is required to contain only information that is consistent with the approved drug label, ie, package insert. Unless otherwise permitted, each product claim must be consistent with FDA-approved indications, dosage forms, strengths, recommendations, etc. Inappropriately describing or minimizing adverse reactions, warnings, precautions, contraindications, and "important notes" would violate this requirement, as well as violate the previously discussed requirement of fair balance. Any communication containing claims that go beyond those in the approved labeling is considered off-label, and can subject a company to significant penalties. Other Miscellaneous Requirements Questionable Practices: Two sections under the Code identify questionable or specifically prohibited practices. These include unapproved representations or suggestions; a comparison of drug safety or effectiveness not supported by adequate and well-controlled studies; information or opinions that have been rendered invalid by more recent information; the selective use of clinical evidence; implications of greater experience than can be demonstrated for a drug; references to literature or studies that misrepresent effectiveness; and the suggestion of clinical effectiveness from nonclinical data. Comparative Claims Comparative claims used in prescription drug promotion must be based on adequate and well-controlled studies. The results from two different studies cannot be compared unless every facet of the studies is the same—the population, environment, etc— which is a difficult task unless performed by the same group with a standardized protocol. A comparative claim
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