For once, the FDA writes up pharma for a simple Facebook violation

Courtesy of Akrimax Pharmaceuticals

The FDA has slapped another drugmaker on Facebook. And this time, the agency's complaints don't raise thorny questions or create new gray areas. The untitled letter to Institut Biochimique and its U.S. partner Akrimax Pharmaceuticals is about as garden-variety as they come.

The drug in question is Tirosint (levothyroxine), a thyroid medication. A Facebook ($FB) page dedicated to the drug failed to mention a few key things, the Office of Prescription Drug Promotion said in its letter.

The page left out any mention of the fact that Tirosint shouldn't be used in patients with one particular type of hypothyroidism, the agency said. And it failed to enumerate the drug's risks. Even the drug's boxed warning--that it shouldn't be used to treat obesity or for weight loss--wasn't included.

"By omitting the most serious and frequently occurring risks associated with Tirosint, the Facebook webpage misleadingly suggests that Tirosint is safer than has been demonstrated," the FDA letter stated (as quoted by Regulatory Focus).

And that's it. The letter included no citations specific to social media. No talk of "likes." No reference to one-click buttons. Rather, the FDA's worries about Tirosint's Facebook page were the same as its worries about any other type of drug promotion: proper disclosure of risks and benefits.

With the agency's social-media thoughts unspooling in a series of individual guidance proposals--some of which are still to come--any action related to Facebook, Twitter, et al., is bound to be scrutinized. The fact that this letter is straightforward--no subtext, no tea leaves--has to be comforting.

- see the FDA letter
- read the RF story

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