OPDP warns Hospira about misleading YouTube video
- The FDA's Office of Prescription Drug Promotion (OPDP) has sent Pfizer-subsidiary Hospira a warning letter regarding the content of a Youtube video advertising its sedative Precedex. OPDP says the video, titled "What to expect: Hospira Precedex," omits full explication of risk.
- OPDP requested a response from Hospira by January 29th, although the video has already been taken down from Youtube.
- According to the OPDP, the video includes "numerous efficacy claims," but does not include any risk information.
The OPDP contends Hospira's Precedex video failed to convey the indications and usage section of its label. Furthermore, the video presented the arousability side-effect of Precedex as a benefit rather than a warning.
Policing social media has been challenging for the FDA as the guidelines in this area are still evolving. However, the requirement of presenting full safety information is clear, with no exceptions to the rule.
The video has been taken off of Youtube as of January 15, 2016, according to MMM-online.com.
Pfizer acquired Hospira, which makes injectable drugs, in September 2015 for $17 billion.
- mmm-online.com OPDP slams Pfizer subsidiary for "misleading" Precedex video