T he FDA can only be sustained if the studies on which it is based are considered to be clinically meaningful or significant. It is not sufficient merely to observe a statistically significant difference between two products. Scientific methodology is based on the principle of reproducibility. More than one adequate and well- controlled study by qualified investigators should increase the probability that a comparative claim is justified. A repeated finding, with similar patients, dosage and duration of therapy, and with proper attention to clinical and statistical integrity, will go a long way toward making comparative claims valid. Package insert comparisons from two different products, even if they are indicated for the same use, cannot be used in advertising or promotion. Each product stands on its own merits of approval for its safety and efficacy. Without head-to-head studies, comparing contraindications, warnings, precautions, or adverse reactions is generally prohibited. Where a risk associated with one drug has been clearly proven not to occur with another product, the second product may promote that fact, even without a head-to-head trial. Comparing the bioavailability characteristics of products from the same therapeutic class can be shown, but no implications of greater safety or efficacy may be inferred or implied. If the data are from published literature, appropriate references must be included. In the current debate about healthcare reform, everyone is discussing the need for comparative data to help make appropriate decisions about therapy. To date, no one has defined what the standards for such data would be, and it remains to be seen how current requirements may change. aomparitive claims used in prescription drug promotion must be based on adequate and well-controlled studies 59
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