Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Pay Attention! FDA to Study If Oldsters Understand TV Drug Ads

Pay Attention! FDA to Study If Oldsters Understand TV Drug Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration wants to figure out just how well older Americans are able to comprehend the prescription drug ads they see on TV.

In an upcoming study, described in a notice posted publicly late last week, the agency will test whether Americans 60 and older understand some of the more complex information presented in the commercials they see between network news and NFL football games. They want to test whether people understand more complex ads as well as they did simpler ads — or if it is too much information for people to process.

Americans 60 and older will participate in the studies, the agency said, because they are more likely to be interested in the drug being studied and therefore more motivated to pay attention. The FDA noted that older people use more prescription drugs and watch more television than younger people.

Participants will be shown TV ads twice for a fictional medication for cataracts. They will then take a survey gauging how well they understood the information in the ad, how well they retained the information, and how they ultimately perceived the drug’s risks and benefits.

The ads will vary. Some will describe side effects more simply, for example, occurring in “10 percent or less” of patients; others will be much more specific — say, 6 percent to 10 percent. Some ads will give only a single outcome for taking the drug (52 percent improved their vision); others will offer an additional outcome (52 percent improved their vision and people were able to see on average 85 out of 100 letters in an eye chart test).

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DTC Marketers Love to Use Animated Critters: Can You Guess Why?

DTC Marketers Love to Use Animated Critters: Can You Guess Why? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
As reported by Ed Silverman/Pharmalot (here), "Over the past few years, more drug makers have run TV [direct-to-consumer, aka DTC] ads featuring cartoon characters or other animation techniques to promote their medicines. But while some may be cute or visually striking, regulators wonder whether these ads interfere with consumer comprehension. So the Food and Drug Administration (FDA) plans to run a study to determine whether these visual tools may distort how consumers perceive the risks and benefits of a medicine, according to a notice posted this week in the Federal Register (here)."

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.”

I was quoted in Silverman's piece:
“I think we are seeing more of these animated ads,” said John Mack, who publishes Pharma Marketing News. “The companies believe the ads can make the products or message friendlier or more appealing. And animation can be used to counteract the unappealing nature of the medication or the side effects that are listed.”


But I also mentioned another reason why I think pharma marketers use these characters. More...

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FDA Wants to Know if Consumers Can Understand Quantitative Information in DTC Ads

FDA Wants to Know if Consumers Can Understand Quantitative Information in DTC Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads.


The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads.


The research comes as a previous FDA study found that simple quantitative information could be conveyed in DTC television ads in ways that increased consumer's knowledge about the drug. However, this research only tested simple information (e.g., one clinical trial, comparison to placebo), whereas other information can be more complicated (e.g., complicated endpoints, multiple study arms). 


In one new study, FDA plans to examine the presence and complexity of quantitative benefit and risk information in DTC television ads. 


"We hypothesize that, replicating past studies, adding simple quantitative information about benefits and risks will lead to increased understanding among consumers. We will test whether adding complex quantitative information results in the same outcomes as simple quantitative information or whether it is too much quantitative information for consumers to process," FDA said in the Federal Register Friday. 


In another study, FDA plans to examine the presence of quantitative benefit information and how the ad visually represents efficacy with various types of images that accurately reflect the improvement in health expected with treatment, or images that overstate the improvement in health that could be expected with treatment. 


FDA hypothesizes that overstated images of improvement will lead consumers to overestimate a drug's efficacy, though it wonders if the addition of a quantitative claim may moderate that effect.


Pharma Guy's insight:

Last year, FDA announced plans to to study the "Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads" (see Federal register Notice). 

"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."

To fill that void, FDA's Office of Prescription Drug Promotion OPDP) plans to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads.

The experimental design calls for volunteers to be randomly assigned to view a prescription drug ad one, three, or six times as part of "clutter reels" embedded in a 42 minute TV program. Read more about this here: "FDA Plans DTC TV Ad Torture Test!"; http://bit.ly/1JZ5sX0 

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Another FDA Study. This Time It's About "Supers" in DTC Ads

Another FDA Study. This Time It's About "Supers" in DTC Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The FDA wants to investigate the nuances of direct-to-consumer advertising, by studying the effect of superimposed text on DTC ads as well as consumer perception of animated characters.

The agency announced Wednesday it will take public comments on a proposal to study the effect of superimposed text, or text placed over an image, on viewers' understanding of a DTC ad.

One example of superimposed text is in Bristol-Myer Squibb's recent DTC ad for cancer drug Opdivo. In the television spot, dubbed Longer Life, the benefits of the drug are cast on buildings.

The FDA, which regulates prescription drug advertising, wrote that it's unclear if previous findings about superimposed text on ads “extend to DTC promotion of prescription drugs and are applicable over 20 years later when viewing promotional materials using today's modern technologies,” like tablets, according to a notice published in the Federal Register.

That earlier research is from the late 1980s and early 1990s. It found that larger text was associated with higher rates of comprehension.

The notice also pointed out that earlier research on “supers” was “conducted with populations (i.e. undergraduate students) that are not representative of today's prescription drug users.”

Pharma Guy's insight:

Also see "Big Pharma's Animated Ads & Mascots To Get FDA Scrutiny"; http://sco.lt/55Wskr 

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Pharma Guy's curator insight, March 28, 2016 8:08 AM

Also see "Big Pharma's Animated Ads & Mascots To Get FDA Scrutiny"; http://sco.lt/55Wskr 

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Big Pharma's Animated Ads & Mascots To Get FDA Scrutiny

Big Pharma's Animated Ads & Mascots To Get FDA Scrutiny | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The U.S. Food and Drug Administration on Tuesday announced plans to study the use of animation in television commercials for prescription drugs, expressing concern that cartoon characters may muddle messages about benefits and risks.

The FDA cited a cartoon character used for Novartis’ toenail infection drug Lamisil in its notice Tuesday.
In a public notice, the FDA referred to a number of prescription drugs that have used animated advertisements over the years. Despite that history, many questions remain about how viewers process the ads, the notice said.

“To our knowledge, no studies have comprehensively examined how animation affects consumers’ benefit and risk perceptions in drug ads,” FDA officials wrote.

One of the agency’s central concerns is that flashy animation could simultaneously attract attention and distract from important statements that an advertisement tries to communicate.

“Personifying animated characters may interfere with message communication,” the notice stated. “Although personification may increase involvement with the characters in the ad … it may not increase involvement with the message itself.”

Pharma Guy's insight:

Also see: "Gallery of Drug Advertising Mascots"; http://bit.ly/mascotgallery Find the notice in the Federal Register here: http://bit.ly/F2016N0538 

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Pharma Guy's curator insight, March 28, 2016 8:07 AM

Also see: "Gallery of Drug Advertising Mascots"; http://bit.ly/mascotgallery Find the notice in the Federal Register here: http://bit.ly/F2016N0538