The latest untitled letter from the FDA’s Office of Prescription Drug Promotion zeroes in on a patient testimonial video about Daiichi Sankyo’s tenosynovial giant cell tumor (TGCT) treatment, Turalio.
The letter (PDF) is dated Nov. 24 and was posted publicly this week. In it, the regulator describes the video—which stars an actual Turalio patient named Siobhan—and pinpoints aspects that it has deemed “false or misleading.”
The video is no longer available on the Turalio patient-facing website, though Siobhan is still pictured and quoted on various pages. A tab titled “Siobhan’s Story” remains visible but is unclickable.
In the video, Siobhan reflects on the physical effects of TGCT, with an animated flashback showing a cold, dark garden to represent how the disease made everyday tasks, including caring for her garden, difficult, according to the FDA letter. The animated Siobhan is shown trapped by vines, then released by a dragonfly representing Turalio.
By the end of the clip, the garden is in bloom once again and the vines have disappeared, as Siobhan says, “I don’t know what the future holds, but I’m optimistic.”
The running theme among the FDA’s complaints lies in how the imagery—including changes in the video’s “mood, lighting, and music,” the regulator wrote—seems to suggest that Turalio can help TGCT patients return to the way things were before their diagnoses, without any limitations, “when this has not been demonstrated.”
The letter went on to cite various studies showing an overall response rate to Turalio of 38% to 61%, with only a portion of patients experiencing a complete response.
“While the patient testimonial in this video may be an accurate reflection of this patient’s own personal experience with Turalio, the testimonial does not adequately support the suggestion that other patients starting Turalio will experience a similar response,” the FDA wrote.
The agency gave Daiichi 15 working days to respond to the letter and asked that it take action immediately to address its complaints.
In a statement sent to Fierce Pharma Marketing, a Daiichi spokesperson said, “We are working closely with the FDA to address their concerns and have removed the video, along with all supporting materials cited in OPDP letter from the TURALIO website and relevant channels. We look forward to resolving this matter and remain committed to providing patients with information that aids in making treatment decisions.”
Since unleashing a deluge of untitled and warning letters related to pharmas’ direct-to-consumer marketing materials in early September, the FDA’s crackdown has slowed to a trickle.
After the Sept. 9 wave, the agency has posted only five more untitled letters. In addition to Daiichi, other recipients include Novartis, AstraZeneca, PharmaTher and SK Life Science.
Editor's note: This story was updated at 10 a.m. ET on Dec. 5 to include a statement from Daiichi Sankyo.