FDA Unfriends Drug Company for Unlawful Promotion

While the Food and Drug Administration (FDA) continues to promise more guidance on product promotion through social media, this hasn’t stopped the agency from taking enforcement action when it believes a promotion is unlawful. Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter to a drug company for its Facebook web page, contending that the page was “false or misleading,” because it made product efficacy claims without providing risk information and omitted material facts. The enforcement letter is consistent with past FDA action, but we believe it is instructive for a number of reasons.

  1. The Facebook page referred to the medical condition for which the product is approved. It is noteworthy that there were no marketing claims, but FDA reiterated that the reference to the condition with the product name was an efficacy claim.
  2. The product contains a Boxed Warning, but the page did not include any risk information. FDA said that this failure to disclose the most serious and frequently occurring risks, and the omission of the Boxed Warning, was misleading, because it suggested the product was safer than had been shown.
  3. FDA noted that the Facebook page did not include the approved indication, although it mentioned, in general terms, the medical condition. By not using the specific indication verbatim, it failed to note a particular exception in the indication. Thus, the agency said that the company omitted materials facts.

AGG Observations

We continue to remind clients, as does FDA to the industry through its enforcement actions, of the following:

  • Provide the indication verbatim from the approved package insert. This way, one minimizes, if not eliminates, the omission of this important fact.
  • A “claim” does not have to be overly promotional to be considered a claim. The Facebook page merely said that, if one had been diagnosed with a particular medical condition, to talk to a doctor about the specific drug product. The reference to both the drug and the medical condition was sufficient to constitute a claim, thereby requiring fair balance and the inclusion of Important Safety Information.
  • A promotion should always include a link to the approved PI.
  • Boxed Warnings cannot use reminder ads or labeling.
  • Products with a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) program are typically scrutinized more by OPDP due to the higher safety risk concern (although all products must be FDA-compliant).
  • OPDP does not provide an exception or latitude for social media promotion, whether it is Facebook, Twitter, or some other forum. Product labeling is broad, and OPDP considers prescription drug product references, in written form, to be labeling, regardless of the outlet. As such, all labeling and promotional rules apply.

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