OPDP ramp-up spawns 7th scolding this year, warning Vanda over omitted risks online

FDA
The FDA's promotional enforcers OPDP slapped Vanda with a warning letter last week over missing risks on a web page. (Andrew Harnik, Associated Press)

The pharma-promo police are suddenly in high gear, issuing their seventh official reprimand of the year, this time a warning letter to Vanda Pharmaceuticals for a webpage. The warning letter—OPDP’s third this month—accused Vanda of failing to include any risk information about Fanapt and Hetlioz on a product web page.

A screenshot posted (PDF) along with the Office of Prescription Drug Promotion letter, submitted Oct. 22 and posted Wednesday, shows the offending Vanda "products overview" page on which both drug names are listed. The page included short paragraphs explaining each drug's official FDA approvals and a link to their branded websites. Vanda said it changed the page on Oct. 23. The same page now shows the drug names with one line redirecting to full prescribing information on each drug’s website. In a statement today, Vanda said it "intends to meet with the FDA to better understand the reasoning of the letter."

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OPDP noted of “particular concern” was Fanapt, an antipsychotic drug approved to treat schizophrenia, because it comes with a boxed warning of serious life-threatening side effects, in its case increased death risk in elderly patients with dementia-related psychosis. Hetlioz is approved to treat the rare disease non-24-hour sleep-wake disorder, a circadian rhythm problem that crops up primarily in blind people.

This is the third letter sent this month, a notable increase over the 2018 pace till now. Before October, the OPDP had only sent four letters. The newest round brings the year's total to seven, already two ahead of last year’s total, with two more months to go.

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John Driscoll, a regulatory affairs consultant, said the sudden increase in activity has caught many in the industry by surprise.

“Although the ‘omission of risk information’ cited in the Vanda letter is standard fare for FDA enforcement, another recent letter to Eisai concerns ‘off-label’ promotion, an area which FDA has been treading quite lightly in the past few years," Driscoll said via email.

"I see no evidence of recent major changes in industry practice," Driscoll added, "so I have to assume a specific decision was made within FDA to make promotional enforcement a high priority."