An op-ed in The New York Times and an opinion piece published in JAMA criticized this Opdivo ad, saying its message is misleading.
The FDA has proposed two studies that would seek to determine how well consumers and healthcare providers can identify deceptive prescription drug claims in branded marketing materials.
The first study would investigate the ability of consumers and HCPs to detect false or misleading promotions when showed two mock pharmaceutical websites, one site oriented toward providers and a separate one for consumers.
See also: 5 questions raised at the FDA’s off-label hearing
The second study would focus on examining whether the participants can identify the difference between implicit and explicit deceptive claims — is the claim overtly wrong? Or is it misleading because it understates certain information? — and whether those claims affect their attitudes and intentions toward the promoted drug.
The notice comes as the agency grapples with an industry pushing for the sharing of truthful, non-misleading information with more stakeholders outside of a drug’s approved label. The FDA has unsuccessfully fought its case in court against Amarin, over its fish oil pill Vascepa, as well as with Pacira Pharmaceuticals for its post-surgery pain drug Exparel, and ultimately settled with both companies.
See also: Off-label promotion: By the numbers
Within the off-label debate, regulators have questioned whether physicians have the time to discern what drugmaker-shared information is potentially misleading, notably in November when the FDA held a public hearing to solicit input about off-label communications
The deadline for comments on the proposed studies is March 6.
