Two Untitled Letters were issued on December 12th for false or misleading risk presentation in broadcast DTC advertisements caused by distracting content. Which ads were cited, what was the FDA precedent, and how can pharma marketers avoid being violative?
A global casualty of the digital age is letter writing, with half a trillion texts sent per month. Folks get particularly nostalgic this time of year as holiday cards also feel the pinch—but the last thing a pharmaceutical company wants to receive under any circumstances is an Untitled Letter from the Office of Prescription Drug Promotion (OPDP) regarding an infraction in promotional material.
The good news is the frequency of these letters has precipitously declined over the past two decades, with only six Untitled Letters issued so far this year (and three Warning Letters, for nine letters this year to date):
Unlike the vast majority of letters that address violations caused by the omission or minimization of risk information, for the first time these cite content and techniques that distract from the risk information for the consumers’ attention. The FDA specifically called out “attention-getting visuals,” on-screen superimposed text and graphics, frequent scene changes, and other “competing modalities” such as background music.
Although the two violative spots differ significantly in style and target audience, both letters share nearly identical language regarding the implications of the distracting content:
“As a result, it is difficult for consumers to adequately process and comprehend the risk information. The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of [the drug]. The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”
Most prior Letters covered more than a single violation, and were directed at smaller pharmaceutical companies. Taken together, the new and singular focus on “attention-getting” content, coupled with the focus on high profile companies and brands, have understandably spooked pharma marketers. Where did this emphasis on “distraction” come from, and what lessons can be learned?
Draft Guidance and Exploratory Research
Pharma marketers must ensure that all promotional materials for prescription drugs and restricted medical devices comply with each applicable requirement from Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Industry requests for clarification on how the FDA evaluates promotional pieces to determine whether they adequately present risk information was provided in draft guidance issued in May of 2009. Using specific examples, the guidance helped clarify agency expectations regarding fair balance, including standards related to consistency, placement, quantity, and modality.
As the FDA pointed out in the draft guidance, “in addition to specific risk-related claims, FDA also considers the net impression conveyed by all the elements of a piece. For this reason, manufacturers should focus not just on individual claims or presentations, but on the messages conveyed by the promotional piece as a whole.” Since the regulation of prescription drug and medical device promotion to healthcare professionals and consumers is a “broad and complex topic,” and “a vast scientific body of knowledge is available regarding human cognition, the FDA relies on this knowledge when evaluating promotional pieces and making regulatory decisions about the presentation of benefit and risk information.”
True to their word, the agency has taken an evidence-based approach to better understand how audiences receive and understand risk information by conducting ongoing research. In June of 2011 the agency released the results of an “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements.” The study tested whether factors such as images, scene changes, words on the screen, and background music have a distracting or reinforcing effect on the understanding of risk information needed for a patient to have an informed discussion with a healthcare professional.
The study revealed that “reinforcing audio-delivered risk information with consistent text during the major statement of an advertisement improves consumers’ risk comprehension and does not impede their comprehension of benefit.” In other words, the agency concluded that sharing fair balance through both on-screen text and voiceover for broadcast TV ads actually reinforced consumer understanding of the risk information—a best practice used in ads we see today.
Another study was conducted to determine whether or not the MedWatch statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088” required in ads since September of 2007 interfered with the comprehension of risk information—and similarly proved to be benign. But the FDA then conducted more research using eye-tracking technology to determine the potential effects of both the MedWatch statement and other stimuli, hypothesizing that “distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information.”
If the two latest Untitled Letters are any indication, then the FDA clearly considers the hypothesis true. The precedent is therefore set, adding “distraction” to every pharma marketer’s concern around risk omission and minimization. What exactly constitutes distracting content and technique seems more subjective, however; in lieu of draft guidance specifically addressing the issue, brand teams must rely on the expertise of their medical, legal, and regulatory teams, and partner with authoritative, trusted commercialization experts to ensure ongoing compliance.
Partner with an Expert
Do you work with agencies you trust? Are they on the pulse of the very latest developments in regulatory and announcements from the FDA? At Klick Health we consider client safety as seriously as our clients consider patient safety. Our in-house team of experienced and accredited medical and regulatory experts keep our clients’ communications compliant and effective. We’ve never received an Untitled or Warning Letter for any of our work, and enthusiastically share our thought leadership and proven experience with the industry. Have any questions about these latest letters, and how to protect your brands? Call us!