Regulatory Focus™ > News Articles > 2021 > 10 > OPDP plans more research on presentation of 'targeted' MoAs

OPDP plans more research on presentation of 'targeted' MoAs

Posted 27 October 2021 | By Michael Mezher 

OPDP plans more research on presentation of 'targeted' MoAs

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) this week proposed new research intended provide insights on how claims, graphics and disclosures about targeted mechanisms of action (MoA) influence consumer and health care provider (HCP) perceptions.
 
OPDP said it is particularly interested in finding out how different presentations of MoA affect consumers’ and HCPs’ understanding of a drug's MoA, its benefits and risks, attention to risk information and interest in the drug.
 
The study would build on earlier and ongoing research conducted by OPDP into how the term "targeted" is interpreted by consumers and HCPs, including a 2014 focus group and a nationally representative survey looking into commonly used phrases in prescription drug promotional materials launched earlier this year.
 
"Although diverse views were voiced [in the focus groups], 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," FDA wrote.
 
In its proposal for the new study, OPDP said it wants to further investigate "the influence of targeted MoA claims, graphics, and disclosures that provide context about a drug's targeted MoA, utilizing an experimental design with both consumer and HCP samples." OPDP added that the study would add to its prior research by allowing it to assess the causality of any influence on consumers and HCPs.
 
The study itself would randomize participants into one of 12 experimental conditions featuring the presence or absence of a targeted MoA claim, a graphic depicting a targeted MoA and a disclosure providing context about a drug's targeted MoA. The product and claims will pertain to fictionalized treatments for bladder cancer and cancers of the urinary tract that have metastasized or are unresectable.
 
"We selected cancer as the medical condition for study given the prevalence of targeted MoA presentations in promotional materials for prescription drugs indicated to treat various forms of cancer," OPDP said.
 
The study will present participants with three variations on graphical depictions of MoAs, including no graphic, an inaccurate graphic that shows only the product's effect on cancerous cells and an accurate graphic. OPDP said the stimuli were "informed by, but not identical to, actual targeted MoA presentations from a marketplace evaluation conducted under FDA guidance."
 
OPDP said it plans to recruit about 540 HCPs, including oncologists and other HCPs with oncology experience, and 540 consumers from the general adult population to particulate in the study.
 
Federal Register notice

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe