Vanda Lands OPDP Warning Letter Over Risk Info on Website

Regulatory NewsRegulatory News | 31 October 2018 |  By 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week sent a warning letter to Vanda Pharmaceuticals for failing to list risk information on a webpage for two of its drugs.
With this latest warning letter, OPDP has issued a total of two warning letters and five untitled letters in 2018, up from the three warning letters and two untitled letters it sent last year.
In the letter, FDA writes that the “Products” page on Vanda’s website fails to include any risk information for the two drugs presented on the page, Hetlioz (tasimelteon)‎, which is indicated to treat non-24-hour sleep-wake disorder, and Fanapt (iloperidone), an antipsychotic approved to treat adults with schizophrenia.
FDA says the omission of risk information for the two drugs misbrands them under the Food, Drug and Cosmetic Act and “creates a misleading impression” about the drugs’ safety.
“Of particular concern is that Fanapt is a drug that bears a Boxed Warning due to serious, life-threatening risks, including increased mortality in elderly patients with dementia-related psychosis, as well as numerous other warnings,” FDA writes.
As such, FDA calls on Vanda to “immediately cease misbranding Fanapt and Hetlioz and/or cease introducing the misbranded drugs into interstate commerce,” and respond to the warning letter by 5 November 2018.
In its response, FDA says Vanda must provide a list of all its promotional materials for the two drugs that make similar representations as those on the webpage and detail how it plans to discontinue the use of those materials.
FDA also says the response should include a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages” to the audiences that received any violative materials and warns that failure to comply may result in actions such as seizure or injunction.
Warning Letter, Materials


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