OPDP Experimental Study to Examine Targeted Mechanism of Action Claims

Nov. 8, 2021 – Whether consumers and healthcare professionals (HCPs) are influenced by “targeted mechanism of action (MoA)” presentations in promotional materials for drugs is the subject of a proposed study by FDA’s Office of Prescription Drug Promotion (OPDP) research division. Public comments on the information collection activities associated with this research proposal are due Dec. 27.

“The proposed study will explore how varied targeted MoA presentations affect consumer and HCP understanding of the MoA of a drug, perception of drug benefits and risks, attention to risk information, and interest in the drug,” according to a notice in the Oct. 28 Federal Register.

This study builds on a line of research announced by OPDP in May 2021: conducting a nationally representative survey of the ways in which consumers and primary care physicians interpret terms and phrases commonly used in prescription drug promotions.

It also will add to the dialogue around the term “targeted” in drug promotion following 2014 focus groups showing that “although diverse views were voiced, there appeared to be some tendency toward the impression that products with promotional materials using this term would be safer and more effective than other similar treatments.”

OPDP is using an “experimental design” for both consumer and HCP samples (540 participants in each leg). Participants in this online study will be randomly assigned to one of 12 experimental conditions in which the presence or absence of three variables are varied in a branded website for a fictitious drug indicated for bladder cancer and cancers of the urinary tract: (1) a targeted MoA claim; (2) a graphic depicting a targeted MoA; and (3) a disclosure that provides context about the targeted MoA.

For the graphic variable, there will be three variations:

  • No graphic;
  • An inaccurate graphic showing only the effect of the drug on cancerous cells but not on health cells; or
  • An accurate graphic showing the effect on the drug on both cancerous and healthy cells.

OPDP chose cancer as the medical condition for the study because of “the prevalence of targeted MoA presentations in promotional materials for prescription drugs indicated to treat various forms of cancer.”