gallery of fda studies of dtc advertising

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Gallery of FDA Studies of DTC Advertising


Is all This “Research” Necessary?



Free Trials, Coupons, Rebates

Going back to 2006: “Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits. The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads “artificially enhance consumers’ perceptions of the product’s quality” while also resulting in an “unbalanced or misleading impression of the product's safety.” http://bit.ly/fdacouponstudy

http://bit.ly/fdacouponstudy




FDA May Be at a Mall Near YouAnnounced in 2007: “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of of Risk and Benefit Information in Direct-to-Consumer (DTC) Prescription Drug Broadcast Advertisements.” The protocol called for FDA screeners to look for con-sumers over the age of 40 as long as they speak English, but don't read Chinese. Whaa?!

The protocol relied on a cognitive science tech-nique called Affect Misattribution Procedure, in which participants are asked not to judge the TV ads’ imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. http://bit.ly/fdamall

http://bit.ly/fdamall

http://bit.ly/fdamall



Quantitative Benefit Information in Ads

Circa 2012: “Presentation of Quantitative Benefit Information in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs.” The studies in this project are designed to address the question of whether consumers can take more complicated information into account when assessing prescription drug information in television DTC ads. Overall, FDA results showed that benefit recall was low, regardless of the particular presentation of information. http://1.usa.gov/1q0pXkc

http://1.usa.gov/1q0pXkc

http://1.usa.gov/1q0pXkc



Disease Awareness AdsCirca 2012: “Disease Information in Branded Promotional Material.” “Some research,” notes the FDA, “has shown that disease awareness advertising is viewed by consumers as more informative and containing less persuasive intent than full product advertising.” When broad disease information accompanies or is included in an ad for a specific product, consumers may mistakenly assume that the drug may solve all of the potential consequences of the condition mentioned in the ad. The prevention of these consequences may be far beyond what the drug has been clinically proven to do.” http://bit.ly/pmn11604h

http://bit.ly/pmn11604h




DTC Ads Directed at AdolescentsAnnounced Oct, 2013: “Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents.” FDA proposes to explore differences in effects of the ad manipulations across these three age groups on a variety of outcomes, including benefit and risk recall, benefit and risk perceptions, and behavioral intentions. Each participant will view a web-based promotional campaign for either a fictitious Attention Deficit Hyperactivity Disorder (ADHD) medication or a fictitious acne medication. http://bit.ly/pmn131002

http://bit.ly/pmn131002




Spousal InfluenceAnnounced November, 2014: “Spousal Influence on Consumer Understanding of, and Response to, DTC Prescription Drug Advertisements.” This study was to examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone. “It may be that when a risk is perceived as particularly negative, viewing with a partner reinforces this perception,” said FDA. “Conversely, it may be that partners downplay risks or emphasize benefits, leading to alternate perceptions and intentions. It is important to generate insight about not only the message portrayed in DTC TV ads but also the conditions under which these messages are received and processed. According to the FDA, some components were withdrawn “due to concerns about their practical utility.” http://bit.ly/pmn131003p

http://bit.ly/pmn131003p




Do TV DTC Ads Overstate Rx Drug Risks?

Announced February, 2014: “Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements.” FDA plans to investigate the effectiveness of a “limited risks plus disclosure” strategy. FDA posits that TV DTC ads could “limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad.” http://bit.ly/fdadtcstudy

http://bit.ly/fdadtcstudy




Impact of Distractions in TV DTC Ads

Announced November, 2013: Study will use eye tracking technology to examine viewer attention to major statement of risk and MedWatch statement in ads. “We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information.”In 2016, FDA sent out two warning letters citing distraction in TV drug ads: http://sco.lt/5U3O2D

http://bit.ly/FDA-eyetrack

http://sco.lt/5U3O2D





FDA Plans DTC TV Ad Torture Test!Announced November, 2014: “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to- Consumer Prescription Drug Ads.” “Generally”" says FDA, “it has been argued that first exposure to an ad results in attention, second exposure affects learning of the advertised message, and third and subsequent exposures reinforce the learning effects of the second exposure. To our knowledge, the literature concerning ad exposure frequency has not been extended to include specific attention to prescription drug ads.” http://bit.ly/FDAtorture

http://bit.ly/FDAtorture

http://bit.ly/FDAtorture



Effect of SupersAnnounced March, 2016: “Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs.” This study seeks to extend previous research on the effects of supers in general print and television advertising to today’s modern DTC pharmaceutical promotion. FDA will examine reactions to supers in a fictitious DTC prescription drug promotional video on two types of viewing devices—TV and digital tablets—with a general population sample. http://sco.lt/4iZ1Zx

http://sco.lt/4iZ1Zx

http://sco.lt/4iZ1Zx



Quantitative Information & OldstersAnnounced March, 2016: “Quantitative Information in Direct-to-Consumer Television Advertisements.” “Because older adults use a disproportionate number of prescription drugs and watch more television than other age groups, their understanding of DTC television advertising is important to investigate. FDA will the agency will test whether Americans 60 and older understand some of the more complex information presented in the commercials they see. Another related study in progress: “Hearing, Aging, and DTC Television Ads.” http://sco.lt/6EDHKD

http://sco.lt/6EDHKD

http://sco.lt/6EDHKD



Animation & MascotsAnnounced March, 2016: “Animation in Direct-to-Consumer Advertising.” It is “possible that animated characters may lead to lower perceived risk by minimizing or camouflaging side effects,” the FDA wrote, adding there is concern that “entertainment aspects can distract from learning key information.” It's pretty obvious that mascots do NOT help physicians and patients recall side effects. So, IMHO, you don't need a study to tell you which way the wind blows on that issue. http://bit.ly/FDAanistudy

http://bit.ly/FDAanistudy

http://bit.ly/FDAanistudy



Space Limited Social Media Ads & Links

The US Food and Drug Administration is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited.

“The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communications used in prescription drug promotion.”

http://sco.lt/5DbIqf





Resources Office of Prescription Drug Promotion (OPDP) Research http://bit.ly/FDADTCstudies How Effective is TV vs Online DTC Advertising? FDA Wants to Know. http://bit.ly/

dtceffectiveness FDA To Study DTC Promotion Directed at Adolescents: Focus is on Immediate

Benefits vs. Deferred Risks http://bit.ly/pmn131002 Cute & Creepy DTC Drug Ad Mascots: FDA Wants to Study How They Influence

Consumers http://bit.ly/pmn150202p Do TV DTC Ads Overstate Rx Drug Risks? FDA May Make Changes that Put Patients

at Risk http://bit.ly/fdadtcstudy Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

http://bit.ly/fdacouponstudy Are Some DTC Print Ads Too Educational and/or Persuasive? FDA Plans to Do Two

Studies to Find Out http://bit.ly/pmn11604h Results from FDA Physician Survey on DTC Advertising http://bit.ly/pmn2102p

http://bit.ly/FDADTCstudies

http://bit.ly/FDADTCstudies

http://bit.ly/dtceffectiveness

http://bit.ly/dtceffectiveness















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gallery of fda studies of dtc advertising

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