Pharmaceutical products comparative claims

Comparative claims The FDA requires that any comparative claim made by a company for its pharmaceutical product be substantiated with scientific evidence. Examples of comparative claims are drug of choice, unsurpassed, or more effective. The supporting studies must be head-to-head —that is, they must be designed prospectively to compare the two products directly. The FDA prohibits a claim of superiority based solely on data derived from two or more studies that are compared, even when those studies have similar protocols. Further, the FDA requires that any comparative claim be clinically relevant to patients. And, if a comparative claim is made, it cannot be false or misleading and cannot leave out other measurements by which the company s product is inferior to its competitor. 

As stated in Chapter 11, dmgs distributed through the informal sector receive little attention compared with those distributed through the formal sector. Counterfeit products, products of dubious quality and faulty information — especially exaggerated claims of efficacy — are often widespread in the informal sector. Monitoring of pharmaceutical activities should cover both sectors. 

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