What makes a misleading ad?

In May 2010, the FDA launched a program designed to help clinicians recognize possible misleading prescription drug promotions and report such promotions to the FDA. Since the program's launch, reports have more than tripled over the previous years' average—from approximately 104 to 328 in 2011.

The most common potential problems with promotional pieces are:

• Overstating the efficacy of a drug. One example would be if promotional materials say, “Drug X delivers results in as little as 3 days” when clinical trials showed results in 12 weeks.
• Omitting or minimizing the risks of the product. A presentation that includes a drug's benefits but not its risks is one example.
• Promoting a drug for a wider range of patients than its approval indicates or for a new, unapproved use.
• Making unsubstantiated comparisons between drugs.

The first drug promotion stopped because of information sent to the FDA's program was a website for Derma-Smoothe/FS^® (fluocinolone acetonide) Topical Oil, 0.01% (Derma-Smoothe). Can you spot the problematic messages? Explanation of the answers is given below. The FDA's warning letter to Derma-Smoothe's manufacturer and the manufacturer's response are available online.

Clinicians can report a potentially misleading ad via phone at 877-RX-DDMAC (877-793-3622) or via email. Anonymous reporting is accepted, but providing contact information is encouraged to allow follow-up if more details are needed. More information about the program is available online.

Explanation of answers

1. 1. The claim “The only product for patients 3 months and older that can be used when their eczema is severe and all over!” suggests use of the drug in a wider range of patients and fails to communicate limitations to the drug's use. Specifically, this claim does not convey that Derma-Smoothe is indicated for moderate to severe atopic dermatitis; does not convey that Derma-Smoothe is only indicated for use up to 4 weeks; and implies that Derma-Smoothe can be used all over the body. The FDA-approved labeling explicitly states that it should not be applied to the diaper area and that the drug should not be used on the face, axillae, or groin unless directed by the physician.
2. 2. The claim “The only corticosteroid that does not cause adrenal suppression, even when used over 90% of the body!” minimizes the risks of Derma-Smoothe, specifically, the associated risk of HPA axis suppression. According to the approved labeling, the use of topical corticosteroids over large surface areas can increase systemic absorption. The warning further states that children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. The image of the baby holding a circular sign with the claim “Safety Concerns” crossed out also minimizes the risk of Derma-Smoothe.
3. 3. The claim that a full course of treatment is only $45 overstates the efficacy of Derma-Smoothe. This presentation implies that one to two bottles of the drug will eliminate the symptoms of atopic dermatitis, when there is no evidence to support that statement. The image of the baby holding a circular sign with the claim “Disappointing Results” crossed out is also misleading.