FDA to Study Adherence and Patient Preference in Ads

FDA is planning research to consider the influence of statements around patient adherence and preference in prescription drug promotion. A Federal Register notice says it isn’t known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer influence perceptions of a drug’s efficacy. A related question, it says, is whether including a disclosure stating the uncertainty around such claims can mitigate any misleading perceptions or influence preferences.

The notice says the specific questions being researched by the CDER Office of Prescription Drug Promotion are whether:

• the presence or absence of an implied adherence claim affects consumers’ and primary care physicians (PCPs)’ behavioral intentions or risk, benefit, and adherence perceptions;
• the presence or absence of an adherence-related patient preference claim affects consumers’ and PCPs’ behavioral intentions or risk, benefit, and adherence perceptions;
• the presence of both adherence and preference claims has a cumulative impact on consumers’ and PCPs’ behavioral intentions or risk, benefit, and adherence perceptions; and
• disclosure of information to the effect that there is no conclusive research on whether a drug results in better adherence mitigates consumers’ and PCPs’ behavioral intentions or risk, benefit, or adherence perceptions.