Risk Communication: Understanding the FDA Draft Guidance

In May of 2009, the FDA issued a draft guidance defining the factors that it considers when evaluating advertising and promotional material for both professional and direct-to-consumer materials. According to the FDA, the goal of risk communication is to help consumers make informed decisions about FDA-regulated products. Doing this means equally conveying both the risks and benefits of these products.

However, what’s interesting about risk communication is that advertising or promotional pieces can be considered deceptive even if specific claims within the ad or promo material are not misleading. According to the guidance, it is the “net impression” that needs to be considered—that is, the message communicated by the piece as a whole. The FDA judgment will also be made based on the intended audience—professional, patient or consumer.

Regulatory Professionals as Allies

Regulatory professionals can help marketers ensure that promotion conveys an accurate and non-misleading impression of the benefits and risks of the product.

“Promotional regulatory professionals should not be viewed as hindrances to commercial goals, but rather partners in the development of effective and compliant promotional materials,” says Zafar Toor, PharmD and Director of Commercial Regulatory Affairs at Eisai. “When regulatory and commercial collaborate, the industry can expect to significantly improve the value of promotional materials to physicians and patients who rely on our healthcare products.”

For example, playing loud music in a TV ad while risk information is being communicated can impede the viewer’s understanding of that information. Other areas cited by the FDA in the guidance that regulatory can provide counsel on, include:

  • The use of consistent language appropriate for the target audience. The way you discuss the benefits must mirror the way you discuss the risks.
  • The use of headlines and subheads. If there is a call-out on the benefit information, there also needs to be one on the risk.
  • Audio and font considerations. The voiceover for the risks should be at the same speed and tone as the benefits. The font should also be comparable. Capital letters are discouraged because FDA believes they are hard to read.
  • Non-specific terms. Being precise is important.
  • Order of risks. These must be listed or conveyed from the most significant to the least significant.

Covington & Burling, an international law firm, published a recap of the FDA’s warning and untitled letters in 2012. These included:

1) Omission and/or minimization of risk information.

2) Overstatement of efficacy.

3) Unsubstantiated superiority claims.

4) Unsubstantiated claims (a broader category than unsubstantiated superiority claims).

5) Omission of material facts.

Fifty-seven percent of the letters contained allegations that the promotional piece(s) omitted and/or minimized the risks of the drug. According to the FDA, the promotion omitted all risk information; included risk information but omitted a particularly important aspect; or included risk information but presented it in a way that minimized its importance.

Fifty percent of the letters alleged that the promotional piece(s) overstated the efficacy of the drug. These types of allegations by OPDP typically encompass outcome guarantees, survival or long-term outcome claims, and suggestions or statements that a drug is more efficacious than has been demonstrated.

According to the law firm King and Spalding, the FDA is increasingly digging into the balance of information provided in a promotional piece and on the overall context in which a particular claim appears—rather than focusing on the truthfulness of individual statements that appear in promotional items.

The Regulatory Affairs Professionals Society (RAPS), also addressed this issue. It notes that fair balance continues to be challenging, especially in regard to the requirement that all advertisements give equal treatment to both the safety and efficacy of a product and that all relevant aspects of both are included.

These considerations extend to TV and video communications too. By omitting the most serious and frequently occurring risks associated with the drug, video news releases can misleadingly suggest that a product is safer than has been demonstrated.

Aesthetics Count, Too

Aesthetic choices in an advertisement also need to be considered. Companies need to be careful when choosing to present points about a product’s efficacy using prominent text, colorful photos, graphics and lots of white space to make it easy to read. In these cases, risk information cannot be crammed together, in black and white, with no headers to distinguish sections, making it difficult to read.

Also scrutinized are large, bolded headlines and colorful graphics to highlight favorable efficacy data in the first section of a pamphlet when safety data appears in the last three pages using no graphics and small font size.

The FDA believes it is critically important to disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers. In this way, consumers know whether drugs or devices are appropriate for them enabling patients to have knowledgeable conversations with their physicians. It also lets consumers know what risks they might experience and what steps they need to take for safety reasons (e.g., no driving) because of taking or using a product.

While the FDA’s draft guidance is 24-pages long, it is worth careful study to ensure that promotional material meets the necessary criteria to avoid unnecessary rewrites. Published data show that rewriting non-compliant materials has a high cost. It hampers compliance and commercial effectiveness, which can quickly result in the loss of $2M annually (or more) for every 10 brands a company markets.

Promotional regulatory professionals can lose as much as 40 hours per month rewriting noncompliant promotional materials submitted by promotional agencies without proven acumen in regulatory compliance fundamentals, according to these studies. This is more than 25% of a regulatory professional’s time. These data do not include time lost to rewrites experienced by a company’s legal, medical or marketing functions. Nor do they factor in the regular fees billed by agencies for developing the original materials that they thought were compliant.

“Tremendous efficiencies can be gained by aligning the expectations of regulatory and commercial, including promotional agencies, up front,” underscores Marsha Shetsky, PhD, MPH, Director, Regulatory Labeling and Promotion, Astellas Pharma Global Development. “If these key stakeholders share a common understanding of the regulatory landscape currently faced by industry, review teams will be able to focus on developing compelling and compliant messaging rather than wasting time dealing with conflict.”

  • Ilyssa Levins

    Ilyssa Levins is President and Founder of Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money and manage risk, when promoting drugs and devices. She combines her regulatory compliance, marketing communications, and change management expertise to help clients achieve their goals.


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