Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

Aug. 5, 2019 – In two new Untitled Letters, the FDA’s Office of Prescription Drug Promotion (OPDP) makes clear that omitting risk information, misrepresenting product efficacy and using visuals that distract from risk messaging in direct-to-consumer (DTC) broadcast ads may draw the agency’s enforcement attention.

In a July 25 Untitled Letter to CooperSurgical Inc., OPDP states that a DTC television ad for the company’s ParaGard® intrauterine copper contraceptive is misleading because it includes claims and representations about the uses and benefits of ParaGard but fails to include important risk information associated with the product.

The letter includes an explanatory statement clarifying that promotional materials can misbrand a drug “if they are false and misleading with respect to risk.” The statement continues: “The determination of whether promotional materials are misleading includes, among other things, not only representations made or suggested in promotional materials, but also failure to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials.”

In this case, the letter states, although the TV ad includes some risk information as on-screen superimposed text (SUPERs), the ad fails to include any of the contraindications for the product, and the voiceover statement fails to adequately communicate the risk of pelvic inflammatory disease with the use of the product. Further, OPDP states that the presentation of certain risk information in the “major statement” of risks through audio and SUPERs is “undermined by the simultaneous presentation of fast-paced visuals that feature choreographed dancing to instrumental music and multiple screen changes.”

OPDP cites CooperSurgical for communicating important risk information in the visual portion (SUPERs) of the TV ad, stating that “TV ads must include information relating to the major side effects and contraindications of the advertised drugs in the audio (or audio and visual parts) of the presentation.”

Further, OPDP asserts that “The overall effect of compelling and attention-grabbing visuals and other modalities competing for consumers’ attention, disclosing important risk information in SUPERs only, and the simultaneous presentation of unrelated risks via SUPERs with competing audio messages undermines the communication of important risk information. As a result, the TV ad misleadingly minimizes the risks associated with the use of ParaGard.”

In a June 14 Untitled Letter to Aclaris Therapeutics Inc., OPDP states that a DTC video promoting Eskata® for the treatment of seborrheic keratoses that are raised fails to include prominent, balancing risk information about the product and misleadingly suggests efficacy that is not typical. The letter asserts that the visuals in the video, such as “before and after” photographs, distract consumers from the risk information. OPDP also points out that it had raised concerns on similar problems in its March 2018 advisory comments when Aclaris submitted the draft Eskata presentation.

The video, which features a discussion with a physician who is a paid spokesperson for Aclaris, “contains claims and/or representations about the benefits of Eskata. However, as described below, the video fails to include prominent, balancing risk information about Eskata,” according to OPDP.

Specifically, the video fails to reveal the serious risks that are reflected in the warnings and precautions for the drug and are intended to be communicated to patients. Although the video includes SUPERs listing the drug’s most common side effects and directs consumers to for more information and the spokesperson refers consumers to the website, “this does not mitigate the video’s omission of the serious risk information regarding the warnings and precautions about serious eye disorders that can result from unintended exposure and about severe local skin reactions.”

By omitting the warnings and precautions associated with Eskata, “the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” OPDP states.

Also, the claims and representations in the video about the drug’s common adverse reactions “create misleading impressions regarding Eskata treatment and the safety profile of the product.” For example, although the common side effects are listed as SUPERs simultaneously with images depicting two patients before and after treatment and in a separate SUPER following these visuals, “the first of these SUPERs also contains efficacy information that is unrelated to the product’s risks,” OPDP states.

Further, the SUPERs “are presented in conjunction with compelling and attention-grabbing before-and-after photographs and the Physician Spokesperson statements. This large amount of unrelated information is presented at a fast pace over approximately 10 seconds and competes for the consumer’s attention. As a result, it is difficult for consumers to adequately process and comprehend this contextual information,” according to OPDP.

To date, OPDP has issued a total of four enforcement letters; in 2018, it issued a total of seven enforcement letters.