Pharmacoeconomic Claims: FTC Views

The US Federal trade Commission says the Food and Drug Administration should consider a "more flexible" substantiation standard for pharmacoeconomic claims made by drugmakers for their products, such as requiring "competent and reliable evidence" to support a claim without any a priori specification as to the type of evidence required.

In comments relating to promotion of drugs in managed care settings, the FTC suggests that providing an economic claim which clearly discloses the nature of the result, and the competent and reliable data on which it is based, "could provide a useful, nonmisleading information to professional and insurance consumers." It goes on: "Accurate economic claims based on actual experiences in the field, particularly when directed to these types of audiences, do not appear to be inherently deceptive or otherwise misleading."

The FDA's current requirement that effectiveness claims be based on adequate, well-controlled studies can prohibit "many truthful, nondeceptive claims describing the cost-effectiveness or cost-benefit characteristics" of drugs in actual treatment settings, the FTC warns. When compliance is tightly restricted during a trial in order to measure efficacy, substantially different results may appear from those found in a clinical setting, where continuation of treatment is more likely to vary with the drug's characteristics. Experience with the drug in a field setting may add substantially to the knowledge based on trial data, or even provide superior economic and effectiveness data in actual practice than in a controlled trial, it says, adding: "such data may also raise questions about the results from controlled trials."