Are Direct-to-Consumer Drug Ads Becoming Fair and Balanced? (2024)

This post was co-authored with Ms. Lily Johns, research coordinator at the University of Michigan.

As discussed in a previous post, direct-to-consumer pharmaceutical advertising (DTCPA) is designed to create positive expectations by minimizing the risks and emphasizing the benefits of a medication. In November 2023, the Food and Drug Administration (FDA) announced a new rule that calls for marketers to communicate drug information in a way that is easier for consumers to comprehend. This new rule may have widespread implications not only in the context of the placebo effect but also for the pharmaceutical industry and the ads you encounter every day.

What is the new FDA rule?

As of May 2024, when the rule will go into effect, the FDA will require TV/radio DTCPA to ensure that the major statement, the segment of the advertisem*nt that lists the side effects or contraindications of the drug, “be presented in a clear, conspicuous, and neutral manner.”

But what does this mean when it comes to DTCPA? The FDA is requiring advertisem*nts to:

• Use language and terminology that is consumer-friendly and readily understandable
• Use audio that is as understandable as audio information in the rest of the ad in terms of volume, articulation, and pacing
• Refrain from using audio or visual elements during the major statement that might interfere with a consumer’s understanding of the content
• Use text that is easy to read
• For TV ads, present the major statement simultaneously in audio and text for long enough to be read easily

This rule responds, in part, to the criticisms of DTCPA from researchers and advocates. In the rule, the FDA highlights that the purpose of the regulation is “[to] ensure that DTC TV/radio ads convey a truthful and non-misleading net impression about the advertised drug, including its risks.”

Current strategies used in direct-to-consumer drug advertising

DTCPA uses different marketing tactics (e.g., positive imagery, movement/action happening on screen) to inhibit understanding of the risks or drawbacks associated with the drug. Although there are certainly some ads that are more balanced in their presentation of risk information, in general, the way that these advertisem*nts portray the risk and effectiveness of the drug is often misleading.

For example, take one of the most popular ads of last year. During the main message, the advertisem*nt makes a claim in large, bold text, while also adding, in much smaller, lighter text, that the drug's efficacy has limitations. In the same frame, the ad states that the drug causes "rapid symptom relief," with a smaller footnote that this relief occurs after “eight weeks” of taking the drug. While symptom relief after eight weeks may be a short time in the world of clinical trials, it may also contrast with a viewer’s concept of "rapid." It’s also important to note that there is a lot of visual movement on the screen during the major statement (e.g., the actors hiking, skiing), which works to distract the audience from reading the fine print, so to speak.

Under the new FDA rule, this ad could look very different. For example, the text at the bottom of the screen listing the side effects or additional information about efficacy would be enlarged, making it easier for the viewer to pay attention to and interpret. Additionally, the amount of movement during the major statement would be lessened, making it easier for the consumer to understand the information. Most important, perhaps, is the introduction of "dual modality" to this commercial, which would require the major statement to be presented in both audio and text form simultaneously. While this commercial currently presents risk information in the smaller text, it does not directly correspond with the audio version. The net result is that ads today highlight select information about medications rather than presenting all information equally.

However, many questions remain about how these standards will actually affect the end product and how consumers engage with it. Foremost, how will this rule be implemented and enforced? Prior studies have found that existing DTCPA ads have poor regulatory compliance, even under the current FDA regime. Additionally, how may the rule affect public trust in pharmaceutical companies, the FDA, or other agents of the healthcare system? This is especially important since the COVID-19 pandemic, which surveys suggest has dynamically impacted the trust that the public has in the pharmaceutical industry and, in some cases, medical research.

Shifting from a form of advertising to a form of health communication?

As previously discussed, advertisem*nts shape expectations of a drug’s efficacy in a way that can affect health behaviors (i.e., specific drug requests) and health outcomes (i.e., by enhancing a placebo response). While the FDA was unlikely considering consumer expectations vis-a-vis the placebo effect specifically, the new requirement for advertisem*nts to provide a more accurate and less biased portrayal of medications may impact perceptions of medications in terms of efficacy (e.g., How much will this drug improve my symptoms?) and risk (e.g., How likely am I to experience side effects from this drug?). With the new rule, the FDA aims to “[help] consumers notice, attend to, and understand the major statement in DTC TV/radio ads” to improve their educational value to the consumer.

However, many might argue that this rule is not enough to shift these ads into a form of health communication. Notably, this rule doesn’t at all address other core issues related to DTCPA that could affect consumer understanding and decision-making. A recent study found that 68 percent of the most-advertised drugs in 2023 were those with low added benefit compared to similar drugs on the market. In other words, many of the ads you see on TV may be an attempt to boost the sales of drugs that have lesser proven benefits (based on the results of clinical trials) and, therefore, are less likely to be prescribed to patients by their doctor. Research has also shown that DTCPA disproportionately targets certain demographics, including women (particularly in ads for antidepressants) and older adults. Therefore, concerns remain regarding tactics used in ads that may mislead consumers, even if information regarding risks and benefits is presented in a more balanced manner.

The FDA rule represents an effort to improve transparency and enhance the educational value of DTCPA. Whether this rule is enforced, and what, if any, impacts it has on consumer understanding of treatment options and subsequent decision-making, is yet to be seen.

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