Guest Column: Direct-To-Consumer Medical Marketing Enters New Era

Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the landscape for the “clear, conspicuous and neutral” manner now required for direct-to-consumer marketing of drugs and devices.

May 20 marks the official effective date of an FDA regulation that eventually will affect the most visible marketing vehicle used by the pharmaceutical industry, namely the ubiquitous direct-to-consumer (DTC) TV and radio ads.

Published Nov. 21, 2023, the regulation implemented a provision in the Food and Drug Administration Amendments Act of 2007, which added to the law the requirement that “… in an advertisement for a drug presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.” The regulation is known as the CCN rule — Clear, Conspicuous, Neutral.

While the regulation takes effect May 20, firms have six months after publication — until November 20 — to bring DTC TV/radio ads into compliance. The agency recommended that ads be brought into compliance as soon as possible but will not take enforcement action until the end of the year.

The rule specifies standards that help ensure that the major statement is presented in a clear, conspicuous, and neutral manner. It says that risk information must be presented in consumer-friendly language and terminology, that the audio information for the major statement must be at least as understandable as the audio information in the rest of the ad, that for TV ads, the audio portion of the major statement must also be presented concurrently in readable text, and that there should be no distractions during the major statement.

The regulation has received relatively little public attention, perhaps because the enforcement date was set a year from its publication. But now, with the enforcement time just six months away, companies and their ad agencies are developing commercials to appear in the fall and winter. They must take into account the need for risk information to be presented more clearly and more explicitly than before.

One of the challenges that companies and agencies will face is the subjective nature of the regulation’s requirements. What does “readable” mean? What words are “consumer-friendly”? What size does the font in supers need to be?

More importantly, how will FDA regulators interpret these terms in a regulatory/enforcement context?

Further, in deciding whether to issue an untitled or warning letter, will the FDA apply a public health standard? All recent enforcement letters from the Office of Prescription Drug Promotion (OPDP) have uniformly stated, in the first paragraph, that the alleged violation being cited represents a “public health” issue. Will the public health standard apply to enforcement of this new regulation, or will the agency take enforcement action if the alleged violation is only technical in nature — for example, if the audio for the risk information is noticeably different from the audio for the benefit information?

This fall, FDA/OPDP regulators are certain to monitor DTC TV and radio ads more closely than ever. Since the first few enforcement letters issued by FDA/OPDP in applying the regulation are likely to be covered by the news media, no company wants to be the first to receive a notice of violation along with the publicity.

Companies can increase their comfort level with the new regulation by submitting DTC ads in advance for an advisory opinion. The PhRMA Guiding Principles on DTC ads encourages companies to seek advisory opinions, and many if not most DTC TV and radio ads are submitted for a non-binding opinion.

As a consequence, the number of enforcement letters issued by OPDP for DTC TV commercials has dropped dramatically compared to the time before it became commonplace to seek an advisory opinion.

Another way to significantly mitigate risk is for companies to sponsor reading comprehension tests for DTC TV and radio ads to assure that the new standards are being met. The comprehension tests, which would carry greater credibility with the FDA if they are designed and conducted by an independent third party, can be submitted with the Form 2253 to support the compliance of the ads. OPDP and other regulators welcome well-conducted research that demonstrates compliance.

One additional issue that companies must address is whether the standards for “clear, conspicuous, and neutral” will also apply to streaming videos that appear in social media or on YouTube, or to videos that appear on a product website. The regulation specifically applies to DTC TV and radio commercials since it implements a provision in the 2007 law that applies only to DTC TV and radio. The regulation is silent as to whether other company-sponsored product videos are also expected to follow the same standards. A good guess is that the FDA will indeed want other videos directed at consumers to follow the same standards, but as of now that is not an explicit requirement.

The next six months will bring a new way of thinking to how risk information is depicted in DTC TV and radio ads, and perhaps to product videos as well. Companies and agencies will have to make judgments as to what is likely to be regarded by the FDA as being in compliance. It will be a challenging time. 

Read the regulation here.

Read the guidance here.

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