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.
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.
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.
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.
Firstly, let's look at how the FDA breaks DTC advertisements into three categories:
- Product Claim
- Reminder
- Help-seeking
Product claim advertisements 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. We're pretty familiar with these types of ads. Think of the magazine ad followed by two-pages of risk information (that no one ever reads) or the long list of risks read at the end of a television commercial.
Reminder advertisements assume the audience already knows about the product, so they mention the name but not the uses. These are trickier to pull-off. 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 (which, by the way, is one of my all-time favorite movies).
Help-seeking advertisements will mention a disease or condition, but not a product name or specific treatment. These types of ads typically encourage the audience to talk to their doctor to find out more information about their condition and treatment options. Help-seeking ads may include a drug company's name (but not the product name), and may also provide a telephone number to call for more information. The FDA does not regulate true help-seeking ads, but the FTC does.
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.
Secondly, keep in mind that when there is a promotion citation issued by the OPDP, it's largely related to the content not the medium:
Here are a few things to keep in mind when creating your DTC campaigns:
Reference to full PI 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.
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.
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.
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 the 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.
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.
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.
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