New 2023 FDA Guidance Released for DTC Promotional Labeling and Advertisements
A new DTC guidance outlines FDA’s recommendations for how industry can include quantitative efficacy or risk information in DTC promotional communications for their drugs to make the language and presentation more consumer friendly. Following the requirements of the Guidance will help companies develop promotional messaging to consumers that is accurate, balanced, and not misleading to conform to the requirements of the Food and Drug Act. A failure to follow the guidance could serve as a basis for enforcement and liability.
The final guidance on “Presenting Quantitative Efficacy and Risk Information in Direct to Consumer (DTC) Promotional Labeling and Advertisements” was released June 2023.
I’ve asked Howard Dorfman, Founder of H.L. Dorfman Pharmaceutical Consulting, to summarize the guidance. Howard is an expert in FDA regulatory law, fraud and abuse, compliance programs, and risk management procedures. He is also author of the Practicing Law Institute’s Answer Book on Pharmaceutical Compliance and Enforcement, and a Visiting Distinguished Professor at Seton Hall Law School.
Perspective by Dorfman
FDA Guidances provide the industry with the agency's current thinking regarding regulatory issues of greatest interest and concern in the development of promotional materials.
As this is a final guidance (draft was first issued in 2018), FDA expects the industry to rely on it for the development of DTC advertising.
A failure to follow the guidance could not only lead to an FDA enforcement action but serve as a basis for liability. As such, they should be integrated into the various company functions involved in the development and review process (e.g., Marketing, Medical, Regulatory and Legal members of the LMR team). Although a pharmaceutical company could choose to utilize a comparable approach, the FDA expects to be consulted to be sure it comports with the guidance.
This guidance is divided into four main sections
(1) Including information from a control group, when applicable,
(2) methods of presenting frequencies (absolute vs. relative)
(3) formatting considerations, and
(4) visual aids.
Guidance Details
FDA has “observed an increase” in the amount of data presentations in DTC advertising and promotional materials. Based on its research analysis, FDA has determined that consumers more easily recall and comprehend efficacy and risk information when it is presented quantitatively rather than in qualitative terms.
Here’s an example:
· Recommended: “Drug X resulted in complete skin clearance in 70% of patients”
· Not Recommended: “Drug X resulted in complete skin clearance in the majority of patients”
Regarding studies with control groups, the guidance indicates the company should provide quantitative information from both the treatment and control groups to help consumers in their evaluation of the benefit and risk of the drug studied.
For absolute vs. relative frequency, the guidance recommends using frequencies or percentages rather than decimals. FDA’s analysis of research suggests that consumers do not understand relative frequencies in health communications as easily as absolute frequencies.
FDA suggests presenting the absolute values prominently and in direct conjunction with the relative frequency measure. For example, a hypothetical drug that improves overall survival in Stage 4 bladder cancer from 1 day to 2 days can be expressed accurately (from both a statistical and regulatory perspective) as “improving survival by 100%” in relative terms, notwithstanding that the absolute benefit is only one day. As a result, absolute values provide important contextual information.
Regarding formatting considerations and Visual Aids, the guidance provides very specific information that will prove helpful in the development of compliant presentations in the DTC context.
For example, firms should include a title, header, or caption (written or oral depending on the media) and identify the visual aid’s variables, scales, and axes (when applicable).
Visual displays of numeric information should be proportionate to the quantity being described and ensure the scaling of axes is appropriate to accurately represent effect sizes. For example, the height of each bar on a vertical bar graph should be proportionate to the numerical value it represents, and the scaling of the y axis should ensure the difference in heights between bars is proportional to the difference in value.
Visual representations of both the numerator and denominator of ratios or frequencies should be included. For example, an icon array, graph, or other visual aid depicting an absolute frequency should represent the people who experienced the effect (numerator) and the total people studied (denominator). When possible, firms should also consider illustrating the denominator as a multiple of 10 in the display.