Patient Compliance Claim Triggers FDA Warning Letter

01-25-2007 | Categories:

Policies & Regulations

An October 11, 2006 FDA Warning Letter addressed, among other issues, the claim by Orapred that the addition of flavor enhancers improves compliance with its product. The FDA letter, excerpted below,¹ focuses on the need for evidence of such claims.

Unsubstantiated Claims
The “NEW INSTITUTIONAL 10-PACKS” link on the main product website claims that Orapred is “ENGINEERED FOR COMPLIANCE,” and the main product website contains the tagline, “Perfecting the Science of Compliance.” Similarly, the “About Orapred” page on the product website claims that Orapred “helps mask the bitter taste of prednisolone, making it easier to take without experiencing the natural gag reflex commonly induced by other liquid formulations of prednisolone.” In addition, the “NEW INSTITUTIONAL 10-PACKS” link on the main product website contains claims such as, “Designed to taste better, ease administration.” We acknowledge that Orapred contains flavor enhancers. However, these claims misleadingly suggest that because of its formulation, patients gag less often when taking Orapred or that the taste of Orapred is superior to that of other formulations of prednisolone and thus that Orapred improves rates of compliance. FDA is not aware of any evidence to support these claims. If you have data to support these claims, please submit them to FDA for review.

Commentary

The FDA’s insistence on scientific evidence rather than the “common sense” assumption that better tasting medications will achieve higher compliance rates is laudable.

My impression is that compliance claims based on a specific quality of a medication (e.g., decreased side-effects, oral rather than parenteral administration, reduced dosing frequency) receive far more regulatory attention than claims made on behalf of non-pharmaceutical compliance enhancers such as adherence monitoring devices, medication reminders, and patient education compliance programs.

Because the notion of expanding governmental oversight gives one pause, and it’s difficult to imagine another source of funding for an independent agency that would serve as a sort of Consumer’s Union for the field, perhaps the message to those of us working with patient compliance is to maintain a high index of suspicion about such claims and to straightforwardly and repeatedly raise the expectation that claims of improved compliance be clarified (e.g., terms defined) and supported by evidence.

Footnotes