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OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

Dec. 15, 2016 – Television ads allegedly making false and misleading claims about the risks associated with their products were cited by the FDA’s Office of Prescription Drug Promotion (OPDP) in Untitled Letters issued Dec. 12 to Celgene Corp. and Sanofi-US. These letters bring the total number of Untitled Letters issued this year up to six; just one Warning Letter was issued so far this calendar year.

In the enforcement letter to Celgene, OPDP states that a TV ad for OTEZLA®, indicated for the treatment of adults with active psoriatic arthritis and for patients with moderate to severe plaque psoriasis, made claims and presentations during the major statement of risks with “compelling and attention-grabbing visuals and SUPERs, all of which are unrelated to the risk message.” The letter also states that “frequent scene changes and the other competing modalities, such as musical interjections, compete for the consumers’ attention.”

As such, these elements undermine “the communication of the important risk information and thereby misleadingly minimize the risks associated with the use of Otezla. The presentation in the video is especially problematic from a public health perspective given the serious risks associated with the drug,” which is contraindicated for patients with known hypersensitivity to Otezla (apremilast) and lists several common adverse reactions on its package insert (PI).

The OPDP letter to Sanofi cites a TV ad for TOUJEO® insulin glargine injection U-300, which is indicated for improving glycemic control in adults with diabetes mellitus but is not recommended for the treatment of diabetic ketoacidosis and is contraindicated during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine. The PI also contains warnings and precautions about the product, as well as common adverse reactions.

OPDP states that the TV ad for Toujeo communicates the major statement of serious risks through the audio and on-screen SUPERs. At the same time, “the TV ad presents fast-paced visuals that feature a man continuously dancing to music … throughout multiple scene changes.” According to OPDP, “these compelling and attention-grabbing visuals” are unrelated to the risk message and distracting to consumers. OPDP issues the same conclusion to Sanofi that it did to Celgene: that these effects undermine the risk messaging and therefore minimize the risks associated with use of the drug.

Both letters state that the TV ads misbrand the products and request that the companies cease use of the ads and submit a written response to the OPDP by Dec. 27.