Pharma now has another hint about FDA's attitudes toward social media. In a recent warning letter to supplement maker AMARC Enterprises, FDA took issue with the company's use of Facebook's "Like" feature. Apparently, the company "Liked" a questionable user testimonial--and the agency didn't like it.
The Facebook mention is just an aside in a long and detailed accounting of AMARC's promotional claims. And some of them are pretty outrageous, as ex-FDA Deputy Commissioner Scott Gottlieb points out in Forbes. One man suggested that the company's Poly-MVA product cured his multiple myeloma. So, this Facebook citation isn't like that very specific warning letter to Novartis ($NVS) in 2010, which slapped the Swiss drugmaker for the Facebook widget on a drug website.
Still, careful drug marketers might want to think twice before they hit that "Like" button. In the absence of detailed guidance on social media, warning letters have been regulatory tea leaves. Even after soliciting industry ideas in a two-day hearing in 2009, and receiving detailed suggestions, such as AstraZeneca's ($AZN) proposed social-media code, the agency hasn't been forthcoming.
Gottlieb says the FDA doesn't want to codify social media use--or much about pharma promotion in general--because it doesn't want to step into a free-speech minefield. That fear might be heightened now, after the recent Caronia v. U.S. appeals court decision. That ruling cleared a pharma rep's off-label marketing on free-speech grounds.
"[O]ne must ask whether this purposeful ambiguity is any way to run a regulatory process," Gottlieb writes. "Without clear rules, we are likely to see companies inadvertently ensnared by FDA's evolving policy over the Internet, until a clear mosaic emerges (from individual warning letters) around how the agency intends to exercise its oversight." Sounds right to us.
- check out the Forbes column
- read the post at RAPS
- see the FDA letter