The Solstice team and I are excited to share a new quantifiable approach to evaluate “fair balance” in prescription drug promotional marketing material, the Solstice Fair Balance (SFB) Score. This score enables teams to measure visual and textual risk and benefit information in new documents. It evaluates each element’s area, saliency, font, and contrast to gauge prominence, allowing targeted adjustments to achieve compliance and reduce regulatory risk. Through this standard, we aim to allow teams to implement a more quantitative, objective method of measuring fair balance and ultimately streamline regulatory review.

Achieving fair balance in prescription drug advertising

The U.S. Food and Drug Administration (FDA) mandates that promotional materials for prescription drugs present a “fair balance” of information. This means that advertisements must provide an equal presentation of a product’s benefits and its associated risks, ensuring that neither is emphasized disproportionately. The FDA's regulations on prescription drug advertising, detailed in 21 CFR 202.1, emphasize the necessity of fair balance to prevent misleading representations. Failure to adhere to these guidelines results in regulatory actions, including warning letters and fines.

Traditional standards require that risks and benefits be presented equitably, but without a clear, quantifiable approach, achieving this balance can often feel like guesswork. We’re proud to launch the SFB Score as part of our Regulatory Assistant to make it easier for life sciences marketing teams to measure, evaluate, and discuss fair balance.

Introducing the SFB Score

The SFB Score was designed to allow teams to quantify a subjective measure in life sciences marketing regulations. We understand the complexities involved in analyzing fair balance in an article and have engineered the platform to take these variables into account, taking into consideration the key differences between content such as audience and type of advertisement. 

Our score thus acts as a guiding framework for marketing and regulatory teams to expedite review committee conversations and align discussions between teams.

How do we determine what is “enough” fair balance?

A threshold for measuring fair balance was determined based on evaluating 1000+ publicly available promotional marketing documents, comparing it across advertisements across different therapeutic indications, disease states, and audience types.

This threshold was determined based on rigorous testing and expert analysis. Over 500 publicly available promotional documents were evaluated. The criteria and thresholds were then revised after an extensive review process from MLR and industry experts. Through this process, a threshold of ±15% for SFB score was determined to assess balance. In other words, a score of 15% suggests the need to increase the prominence of risk information and a score of -15% suggests the need to increase the prominence of benefits information.

How exactly Solstice calculates the SFB score

Comprehensive Content Parsing:

We begin by parsing each element within the marketing file, identifying and categorizing every component—such as text, images, and figures—as either a "risk" or a "benefit" or “neither.”

Detailed Visual Emphasis Analysis:

Each element is then evaluated on multiple dimensions that affect visual prominence:

• Area Occupied: The portion of the page taken up by each element, giving insight into its relative importance.

• Dynamic Saliency: Saliency is calculated uniquely for each document based on how elements are positioned and visually weighted. Our saliency score evaluates which parts of a page naturally draw the viewer's eye first. For example, elements placed at the top center or highlighted with vivid colors may have a higher saliency score, making them visually prominent and more likely to catch attention. This dynamic calculation ensures that the score adapts to the layout and design of each unique document.

• Font Properties: Emphasis indicators such as boldness, italics, and font size that draw attention are evaluated to determine the emphasis of each claim.

• Color Contrast: The contrast between text and background color, affecting readability and visual appeal.

Scoring with Weighted Criteria:

Each element receives a score based on weighted criteria, combining all four dimensions into a composite score:

Risk vs. Benefit Scoring and Aggregation:

Once scores are calculated, risk and benefit elements are scored separately, allowing us to ensure both are equally emphasized. We then determine the SFB Score Percentage using the formula:

Real-World Applications of the SFB Score

To demonstrate the score’s practical application, we tested it on sample real-world ads. With these insights, companies can make targeted design adjustments to achieve fair balance and reduce regulatory risk. Here’s a quick look at one of them:

Figure 1: Entresto patient brochure

Figure 2: Dynamic saliency analysis

Figure 3: Risk/benefit prominence analysis

Next Steps

At Solstice, we are committed to equipping marketing and regulatory teams with the tools they need to launch campaigns faster in a compliant manner. We believe in the importance for teams to present safety and risk information. The SFB Score is a key part of our effort to promote more objective, transparent, and efficient conversations during regulatory review about how this information is presented by evaluating each piece independently. We look forward to hearing how this supports your work.