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Drugmakers are officially on notice about their direct-to-consumer ads.
Over the past week, the Food and Drug Administration has issued an estimated 100 warning letters to pharma and biotech companies over claims their DTC ads are violative in nature.
This action comes amid a concerted step up in enforcement of restrictions on DTC pharma ads by the Trump administration.
On Tuesday, the FDA published about 40 warning letters on its website about pharma ads that the agency deemed “misleading.”
Check out 15 ads flagged by the FDA, as well as the reasons why:
Attruby, BridgeBio: Golden Years
Why it was flagged: The FDA claims the spot “misleadingly suggests that treatment with Attruby will broadly improve a patient’s overall quality of life when this has not been demonstrated.”
Austedo XR, Teva: Daughter Knows Best/Spouse Knows Best
Why it was flagged: The FDA claims these ads “misleadingly suggest” that Austedo XR provides a “greater magnitude of benefit in the treatment of tardive dyskinesia than has been demonstrated.”
Auvelity, Axsome Therapeutics: Print advertisement
Click here to view print advertisement.
Why it was flagged: Axsome’s claims and presentations, which appear next to an image of a woman smiling and appearing happy and joyous, “create a misleading representation that treatment with Auvelity will provide a specific benefit of improving symptoms of anhedonia in patients with MDD, allowing patients to feel pleasure and joy, when this benefit has not been demonstrated,” according to the FDA.
Calquence, AstraZeneca
Why it was flagged: The FDA takes issue with the presentation of the drug’s risk profile, stating it creates a “misleading impression that patients on Calquence can maintain a normal, active lifestyle while undergoing treatment, thereby downplaying the serious side effects and monitoring requirements.”
Camzyos, Bristol Myers Squibb: Storyboard: Feel/See Basketball
Why it was flagged: The FDA says the ad creates a misleading impression that all patients with obstructive hypertrophic cardiomyopathy (HCM), while being on treatment with Camzyos can engage in the activities in the spot with little to no restrictions, which has not been demonstrated. It also said the ad “omits material risk information pertaining to the warning and precaution for embryo-fetal toxicity.”
Contrave, Nalpropion Pharmaceuticals (owned by Currax Pharmaceuticals): Don’t Owe Me
Why it was flagged: The FDA says the ad’s claims are “misleading because they suggest that Contrave’s mechanism of action in relation to its therapeutic effect is fully understood when this is not the case.” It said the ad also fails to include the warning and precaution for activation of mania / manic episodes. By omitting these “serious risks associated with Contrave and material information pertaining to the risks of Contrave, the TV ad creates a misleading impression of the drug’s safety,” the FDA said.
Fasenra, AstraZeneca: Pulled Back Out
Why it was flagged: The FDA argues the ad shows “compelling before-and-after presentations imply an improvement in social and emotional functioning. Before Fasenra treatment, the woman is described and presented as bored, stuck at home, and ‘losing [her] groove.’ In contrast, after Fasenra treatment, she is portrayed as someone with an active social life, involving salsa dancing, that is captured on social media as a photo garnering numerous ‘likes.’” It notes clinical studies did not study whether social and emotional functioning were tracked.
Ingrezza, Neurocrine: Uncontrollable Movements
Why it was flagged: These claims misleadingly suggest that patients will experience improvement in TD symptoms earlier than was demonstrated in the clinical trial. The ad also misleadingly suggests that almost all patients who take Ingrezza are satisfied with their treatment because those with unfavorable responses to treatment with Ingrezza may not enroll in the rollover study.
Jardiance, Boehringer Ingelheim: Musical: Movie Night
Why it was flagged: The FDA states the ad is misleading because the size and style of font, contrast with background, and placement on screen of the text portion of the major statement, do not allow the information to be read easily. The FDA says the ad is misleading because of the frequent scene changes and compelling, attention-grabbing visuals (e.g., a photo stand-in with face holes, a movie screen, a man throwing up popcorn and catching in mouth, enlarged popcorn bucket props, a man operating a film projector with flashing lights, a dog wearing 3D) compete with the viewers’ attention during the major statement.
Jublia, Bausch: Yoga Class
Why it was flagged: A TV ad for Jublia, a nail fungus treatment, is criticized for misrepresenting its efficacy and speed of results. The ad depicts onychomycosis as a “Bigfoot foot” and claims “don’t fear the fungus,” suggesting an easy, complete cure. However, clinical trials show low complete cure rates (15.2%-17.8%). The ad also implies immediate results, while the recommended treatment is 48 weeks, with efficacy assessed only at week 52. A disclaimer about treatment duration and varying results appears too late and lacks emphasis, failing to mitigate the misleading impressions.
Kesimpta, Novartis: My Time My Way
Why it was flagged: The FDA flagged the ad’s claim that Kesimpta can be completed in “1 minute” as misleading because it oversimplifies the steps involved, which requires the first injection of Kesimpta “should be performed under the guidance of a healthcare professional.”
Linzess, AbbVie: Jeff
Why it was flagged: The FDA takes issue with the presentation of the major statement. The visuals, which include a father giving an excited daughter a gift that she opens, contain too many frequent scene changes and compelling and attention-grabbing visuals. It says those visuals interfere with comprehension of the major statement.
Quilpta, AbbVie: 30-second DTC broadcast advertisement
Why it was flagged: Another instance of the FDA taking issue with the major statement because of attention-grabbing visuals like a child climbing down a rope on a playground, a group of children boarding a bus, the chaperone taking a photograph with all the children on the bus which transitions to a woman circling a date on a calendar featuring the picture of the children on the bus).
Velsipity, Pfizer: Musical: 60-second DTC broadcast advertisement
Why it was flagged: The TV ad’s major statement contains images of the creature shaking the main character’s leg trying to get his attention, rolling around on the ground, and chewing on something it found outside. These images interfere with comprehension of the major statement.
Voquezna, Phathom Pharmaceuticals: Kenan Thompson DTC videos
Why it was flagged: The video is misleading because it presents efficacy claims for Voquezna but fails to communicate any risk information. The video, however, entirely omits all risk information. By omitting the risks associated with Voquezna, the video fails to provide material information about the consequences that may result from the use of Voquezna and creates a misleading impression about the drug’s safety.
