Posted 20 January 2016
By Zachary Brennan
The US Food and Drug Administration’s Office of Prescription Drug Promotion has hit Pfizer subsidiary Hospira with an untitled letter over the company's "misleading" YouTube video on its sedative Precedex.
FDA says the video, titled, “What to Expect: Hospira Precedex (dexmedetomidine HCl Injection) by Hospira, Inc. (Hospira) for Precedex (dexmedetomidine hydrochloride) injection,” was never submitted to OPDP and is misleading “because it omits risks and material facts associated with Precedex. Thus, the video misbrands Precedex within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and makes its distribution violative.”
More specifically, FDA is taking issue with the way the video “makes representations about the use of Precedex for intensive care unit sedation.”
And though the video contains numerous efficacy claims for Precedex, it fails to include risk information associated with the use of the drug. In addition, the video “alludes to arousability, this is presented as a benefit (i.e., what makes it ‘different’ than other sedatives), instead of a warning and precaution.”
According to its FDA-approved product labeling (PI), Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.
A Pfizer spokeswoman via email told Focus on Thursday: "The Precedex video was not intended to be viewed outside the Precedex web site, which contained the important safety information until it was taken down on Sept. 2, 2015, as part of a routine review of web-based assets following the integration of 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. Hospira is in the process of reviewing and responding to the OPDP letter."
OPDP requests that Hospira immediately cease violating the FD&C Act, and provide a written response to this letter by 29 January, 2016, stating whether it intends to comply with this request, listing all promotional materials for Precedex that contain violations such as those described above, and explaining its plan for discontinuing use of such violative materials.
This is the first untitled letter issued by OPDP this year.
OPDP Untitled Letter
YouTube Video [Editor's note: A Pfizer spokeswoman told us that this video is not identical to the video cited by FDA in the letter though it may be one of Hospira's, and the company is continuing to investigate.]