Why DTC Advertising Shouldn’t Make Us

Feel Guilty

Have You Experienced This Feeling?

You're driving down the highway, when suddenly you spot a police officer or a state trooper in your rearview mirror. You're driving the speed limit; your tags are up-to-date, yet you suddenly feel guilty – like you've done something wrong.

Why DTC Advertising Shouldn’t Make Us Feel Guilty

This is how the FDA makes us feel when it comes to running direct-to-consumer (DTC) advertising for medical devices and pharmaceuticals. More often than not, you aren't doing anything wrong. But your anxiety levels run high as soon as you step on the gas.

2014 Marked a Record Low Year

Did you know that 2014 marked a record low year in terms of enforcement letters issued by the FDA's Office of Prescription Drug Promotion (OPDP)!? Only 9 untitled letters and 1 warning letter were issued, compared to 24 the previous year.

Guilt-Free DTC Advertising

We know that DTC advertising can be an excellent mechanism to provide useful information to consumers and educate them about new treatment options. Typically it even encourages the consumer to speak directly with their doctor to make smart decisions about their treatment plan and overall health.

To educate patients guilt-free, start by reviewing the FDA's guidelines* for prescription drug advertising. Note: There is no specific guidance carved out for medical devices.

*http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072077.htm

DTC Advertising Categories

Firstly, let's look at how the FDA breaks DTC advertisements into three categories:

–  Product Claim

–  Reminder

–  Help-seeking

Product Claim Advertisements

Product claim ads mention the product by name. They should be accurate and

present benefit and risk information in a

balanced manner. All product claim

advertisements must include the product

name, at least one FDA-approved use,

and the most significant risks.

EXAMPLE: CORRECT AD

Reminder Advertisements

Reminder advertisements assume the

audience already knows about the

product, so they mention the name but

not the uses. These types of ads do not

need to mention risks, but they also

cannot imply, even through imagery,

anything about the drug's or product's

benefits or risks. This can be subjective,

so make sure you discuss this in detail

with your regulatory and compliance

teams so nothing is lost in translation.

EXAMPLE: CORRECT AD

Help-Seeking Advertisements

Help-seeking advertisements will mention a

disease or condition, but not a product

name or specific treatment. These

typically encourage the audience to talk to

their doctor to find out more information

about their condition and treatment

options.

These may include a drug company's name

(but not the product name), and may also

provide a phone number to call for more

information. The FDA does not regulate

true help-seeking ads, but the FTC does.

EXAMPLE: CORRECT AD

Who Has Jurisdiction?

The FTC, FDA, and USDA actually share jurisdiction* over claims made by manufacturers of food products pursuant to a regulatory scheme established by Congress. Since 1954, the FTC and the FDA have operated under a Memorandum of Understanding, under which the FTC has primary authority for advertising of foods, supplements, and OTC drugs and devices while the FDA has primary authority for labeling of products and for advertising of prescription drugs and devices. Help-seeking advertisements that encourage consumers to see their doctor about a condition, but does not promote a specific device, fall under the FTC's purview.

*https://www.ftc.gov/public-statements/1994/05/enforcement-policy-statement-food-advertising%235

Focus on the Content

Keep in mind that when there is a promotion citation issued by the OPDP, it's largely related to the content not the medium:

A Few Things to Keep in Mind

Reference to full prescribing

information does not cut it if

you're creating a product claim

ad. You can include the Boxed

Warning, but also need to

include any contraindications,

other serious warnings and

precautions, and common

adverse events.

EXAMPLE: INCORRECT AD

A Few Things to Keep in Mind

Superiority claims require data from adequate and well controlled, head-to-head trials designed to measure clinical superiority. Review articles, non- clinical studies and low-powered studies are not substantial evidence for efficacy claims.

EXAMPLE: INCORRECT AD

A Few Things to Keep in Mind

The OPDP scrutinizes visual representations and not just text. Unsubstantiated superiority claims can be interpreted from a seemingly innocuous image. For example, an image of a single white sheep among a group of black sheep could be interpreted to mean the product is more reputable than a competitive option.

A Few Things to Keep in Mind

Images can also be viewed as

implying claims that may be

outside of the FDA labeling. For

instance, a stock image of a middle-

aged man jogging through a park

could imply that a drug will improve

COPD. We know, cue the eye rolling,

but the FDA is the beholder and they

have a very specific eye for "beauty."

What’s Next in DTC

While DTC TV and print advertising are still going strong, more and more device and pharmaceutical companies are allocating their budgetary dollars to DTC digital advertising. This is largely because research shows that more and more consumers begin their medical information search online. A 2013 report from Pew Research Center* found that 77% of online health seekers say they began their last session at a search engine such as Google, Bing, or Yahoo. Another 13% say they began at a site that specializes in health information, like WebMD.

*http://www.pewinternet.org/fact-sheets/health-fact-sheet/

What’s Next in DTC

Today, companies can leverage contextual targeting to intersect with consumers who are searching keywords that relate to their product or condition solution. Despite tight restrictions around digital advertising, many medical companies are following guidelines for help-seeking ads when running display and pay-per-click (PPC) ads and driving consumers to websites or landing pages where more complete product claims and risk information can be provided. We wrote at length about PPC advertising in a recent blog post* if you want to check it out.

*http://www.greymattermarketing.com/blog/pay-per-click-advertising-as-a-medical-device-company

What’s Next in DTC

As consumerism continues to rise in healthcare, DTC advertising

may become one of the most effective ways to reach a key

audience segment. Go forth and be confident that you're doing the

right thing with your DTC advertising—and save your guilt for that

donut you just ate in the break room.

Grey Matter Marketing is a full-service, award-winning marketing agency working exclusively with medical technology companies. We provide the marketing architecture to build strong connections with providers and patients to drive adoption of innovative technology that improves lives. We have a proven track record in developing both traditional and digital plans that create compelling marketing experiences and drive business results. Our strength is finding the important truth in any communication effort, and translating that truth into something your customer understands, and more importantly, feels. Armed with this knowledge and insight, we roll up our sleeves and do what we do best: work hard, think strategically and deliver.

IF YOU ARE INTERESTED IN LEARNING MORE ABOUT WHY DTC ADVERTISING SHOULDN’T MAKE US FEEL GUILTY EMAIL US AT INFO@GREYMATTERMARKETING.COM