August 31, 2015

Is The FDA Ready For Kim Kardashian And Mutant Head Lice?

By Molly Knobler and Tim McCormack (published on the Huffington Post blog)

A pharmaceutical company was recently reprimanded by the FDA for its misleading marketing tactics on an unexpected forum—Kim Kardashian‘s Instagram feed.  The new mother’s failure to address the full safety profile of morning sickness drug, Diclegis, prompted the FDA to issue a warning letter to the drug’s manufacturer.  This sort of enforcement is representative of the new focus of FDA regulation emerging in response to recent wins by big-pharma against enforcement of “off-label marketing” rules.  While the Kardashian warning was a good start, the recent furor over “super mutant head lice,” prompted by arguably inappropriate prescriptive advice by authors of a recent study, demonstrates that the FDA must be prepared to address misleading claims of drug safety and efficacy in all their forms.

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