FDA plans to check remedy adherence claims, endorser impact in DTC promoting

Regulatory Information

| 22 September 2022 | By Ferdous Al-Faruque 

The US Meals and Drug Administration’s (FDA) Workplace of Prescription Drug Promotion (OPDP) stated it plans to conduct two research wanting into affected person and doctor perceptions of remedy adherence claims in on-line advertisements and the way endorser standing and actual-use disclosures affect viewers’ notion of medication in tv advertisements.
 
On 22 September, OPDP introduced its plans to check how on-line commercials for medicine that embrace claims of improved remedy adherence are perceived by customers and first care physicians.
 
FDA famous that remedy non-adherence is a widely known problem in well being care, and it’s estimated that solely half of the sufferers with power diseases take their remedy as prescribed. Pointing to latest analysis, the company stated that as much as 100,000 individuals die preventable deaths annually attributable to remedy non-adherence, leading to $100 billion in added prices to the well being care system.
 
“As consideration to the general public well being subject of remedy adherence has grown, OPDP has famous a corresponding improve within the variety of claims and shows in prescription drug promotion that focus, both immediately or via implication, on a product’s potential to enhance adherence to remedy regimens,” FDA stated. “Many of those shows embrace details about choices and capabilities accessible to assist sufferers monitor their remedy utilization.”
 
FDA stated that a lot of these choices use software program linked to gadgets corresponding to a affected person’s smartphone to not solely monitor however alert sufferers when they should take their remedy. Nonetheless, they notice that there isn’t sufficient knowledge on how customers understand such capabilities.
 
“Little or no is thought about affected person and well being care supplier perceptions of merchandise that monitor remedy use or that work in tandem with software program to trace remedy use, with most commentaries having been largely theoretical,” stated FDA. “The main target of the current research is to discover affected person and well being care supplier perceptions of a fictitious prescription drug product that’s accompanied by software program that’s meant to trace remedy use.”
 
FDA stated it plans to run a two-part research that features an preliminary research with 50 customers and 50 major care physicians who shall be pretested utilizing a web-based questionnaire. Afterwards, the company will recruit 350 customers who self-identify as having diabetes and 350 physicians who deal with diabetes to guage 5 completely different shopper net pages for a fictitious prescription diabetes remedy that goals to know the impact of drug-adherence claims.
Endorser standing and ‘precise use’
 
FDA additionally plans so as to add to ongoing analysis into how completely different endorsers of medication are perceived by customers and well being care suppliers. The continuing research is ready to finish in 2024 and appears at several types of DTC endorsers in print or on web sites. Now, the company desires to conduct a further research that focuses on tv advertisements titled, “Endorser Standing and Precise Use in Direct-to-Client Tv Advertisements.
 
The company stated that previous analysis has proven that customers are most certainly to purchase a drug if it has been endorsed by an knowledgeable doctor or pharmacist, adopted by endorsements from different customers and lastly by a celeb.
 
“The current analysis will particularly look at the affect of two impartial variables – endorser kind (affected person, doctor) and an actual-use disclosure (utilizer, actor, none) — in tv commercials,” stated the FDA. “Dependent variables will embrace perceptions of the dangers and advantages of the promoted prescription drug, attitudes towards and perceptions of the endorser, consideration paid to the advert, and behavioral intentions.”
 
The company additionally plans to check whether or not the age and training degree of the patron influences their notion of the advert.
 
The research shall be damaged into two components. The primary research will take a look at the perceptions of sufferers who’ve been identified with diabetes and the second shall be for sufferers with rheumatoid arthritis. In each research, contributors shall be proven advertisements for a fictitious drug and can file their perceptions primarily based on whether or not the endorser is a affected person or a doctor.
 
Pretests of every research will recruit 126 customers who both self-identify as having diabetes or rheumatoid arthritis. Then, FDA will conduct important research with comparable cohorts with 648 self-identified sufferers in every illness space.
 
The research are the newest in a sequence of analysis FDA is conducting to know prescription drug promotion, together with one proposed final yr to analyze how claims, graphics and disclosures about focused mechanisms of motion (MoA) affect shopper and well being care supplier (HCP) perceptions. FDA introduced that it plans to proceed with that research, with some revisions made primarily based on enter it acquired throughout the public remark interval. (RELATED: OPDP plans extra analysis on presentation of ‘focused’ MoAs, Regulatory Focus 27 October 2021)

 

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