OPDP Sends Second Enforcement Letter of the Year

The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter to the manufacturer of a weight-loss drug for its Internet promotion. According to OPDP, the homepage of the consumer website made false or misleading claims about the efficacy (four violations concerning overstatement of efficacy) and risks associated with the drug (minimization of risk). OPDP found this misleading consumer-directed presentation to be “especially concerning,” because obesity and excessive weight are significant public health concerns that affect millions of people and are associated with numerous co-morbidities.

We will briefly describe OPDP’s major objections and note our observations.

False or Misleading Claims about Efficacy

• The first violation concerned claims that the drug can help patients lose weight three times faster than diet and exercise alone. OPDP concluded that the cited references [calculations and the full prescribing information or package insert (PI)], do not support the claims. Although the calculations were derived from the studies in the PI, the studies were designed to evaluate the amount of weight loss, and not the rate of weight loss.
• In the second violation, OPDP highlighted a partial statement of the drug’s approved indication that was followed by several weight loss claims. OPDP objected to this presentation, because it failed to mention that the drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity; in other words, not the complete indication. Despite the fact that the complete indication was stated later on the webpage, OPDP found this presentation to be misleading.
• The third and fourth efficacy violations focused on a presentation highlighting data for “pounds of weight loss” and “inches off your waist” at three distinct time points during the clinical trials. OPDP concluded that this presentation was misleading because it selectively presented the more favorable absolute amount of weight loss and reduction in waist circumference, while failing to account for a patient’s baseline weight and waist circumference. The efficacy outcomes in the PI were measured in the context of a patient’s baseline weight and waist circumference.
• Finally, OPDP stated that the presentation reflected patient data from distinct points during the clinical trials of only those patients who remained on the drug, failing to account for a substantial percentage of patients who withdrew from the studies. Again, OPDP determined that, by cherry-picking data from the PI and not providing context, the presentation overstated the efficacy of the drug.

False or Misleading Risk Presentation

• OPDP alleged that the webpage failed to present the drug’s risk information with a prominence and readability reasonably comparable to the presentation of the drug’s benefits. Benefit claims were presented in conjunction with colorful graphics and large bolded headlines with significant white space. Risk information was relegated to the bottom of the webpage, in paragraph format, and was not easily accessible (viewers had to scroll down past the entire benefit presentation). In addition, the webpage did not present a “significant signal” to alert readers that important risk information followed the benefit presentation.

AGG Observations

This Untitled Letter reminds us that:

• Efficacy claims must be adequately supported by the clinical studies in the approved labeling or data on file. OPDP will carefully scrutinize the studies/data cited in support of the claims. Efficacy claims that selectively present more favorable data (even from the PI), or otherwise overstate a product’s effectiveness, will be viewed as misleading.
• Statements referencing the products approved indication must include the complete indication and any limitations. A complete statement of the indication near the end of a promotional piece or webpage will not be sufficient.
• Risk information should be presented with a prominence and readability reasonably comparable to benefit claims. The letter provided helpful guidance to industry. Presentation and prominence of risk information affects every company, no matter the nature of the drug. One way to accomplish this is to: (1) sprinkle risk information in with benefit claims, and (2) include a signal that additional risk information appears below. Including only an Important Safety Information section at the bottom of a piece or webpage may not be sufficient.
• As this is only the second enforcement letter from OPDP this year, it is impossible to identify any trends. However, this letter appears to follow the direction that FDA established late last year to concentrate on violations that raise significant public health concerns. In addition, the letter steers clear of controversial First Amendment issues (e.g., off-label promotion) by identifying violations that are false or misleading. Moreover, consumer-directed materials, such as this patient website, continue to warrant heightened scrutiny.