FDA slaps Pfizer's Hospira unit for 'misleading' YouTube ad

In the first enforcement action from the FDA's marketing police this year, the Office of Prescription Drug Promotion put Hospira in the hot seat over a YouTube video for its sedative Precedex.

The OPDP sent an untitled letter dated Jan. 14 to the Pfizer-owned company, charging the video "omits risks and material facts" about the drug. The agency also rebuked Hospira for publishing the promotional video without submitting it to the OPDP for review.

The letter orders Hospira to "cease violating the FD&C Act, as described," and submit a written response before Jan. 29. The response should include a plan for "discontinuing use of such violative materials," the letter states.

A Pfizer ($PFE) spokeswoman noted in an emailed statement that the video was taken down in September and was not directly accessible before that.

"The Precedex video was not intended to be viewed outside the Precedex website, which contained the important safety information," the statement said, adding that the video was taken down as part of a web review after Pfizer bought Hospira.

"Although the video was not accessible to the public, further steps have been taken to remove the cited content from the Hospira YouTube channel as of Jan. 15, 2016," the spokeswoman said. "Hospira is in the process of reviewing and responding to the OPDP letter."

Pfizer completed its acquisition of Hospira, an injectables and biosimilars company, in September. The $16 billion buyout is expected to help make Pfizer a leading player in the biosimilars business and beef up its established products unit for a potential sale or spinoff.

Last year, the OPDP sent just 9 letters to pharma companies for marketing violations, down from 10 in 2014 and 24 in 2013. The last OPDP letter in 2015 was in August, a warning to Duchesnay for an Instagram posting by reality star Kim Kardashian. The celeb had touted its pregnancy anti-nausea drug Diclegis without including full risk and side effect information in the post.

- read the full OPDP letter (PDF)

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.