In 2019, the U.S. Food and Drug Administration's ("FDA" or "the Agency") Office of Prescription Drug Promotion (OPDP) issued three warning and seven untitled letters to pharmaceutical companies for promotional materials that allegedly misbranded prescription drug products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Agency’s regulations. These letters show the Agency’s enforcement focus is on advertisements that fail to warn of serious risks, do not present those risks with a prominence comparable to that of information about the drug’s benefits, and promote an unapproved drug. These OPDP letters also show that FDA continues to pay attention to promotion via traditional media, but is also monitoring manufacturers’ increasing promotional activity in digital and social media.

In two of the letters, OPDP cited prior Agency correspondence regarding similar claims, such as advisory comments or guidance that had been provided to the previous sponsor of the drug. This underscores that companies that have already been cautioned by FDA regarding certain promotional claims or presentations should take particular care to ensure their current drug advertisements comply with FDA’s thinking and feedback. While the frequency of OPDP letters continues to be relatively low, 2019 marks the third consecutive year that the number of enforcement letters has increased and may suggest a renewed appetite to curb promotional practices that OPDP views as having the potential to harm the public health.  

OPDP focuses on failure to warn of serious risks

Nearly every letter issued by OPDP in 2019 cited one or more failures to include risk information, with letters focusing on failure to warn about “serious risks,” especially permanent or potentially fatal risks, those affecting a “vulnerable patient population,” and risks that present a “public health concern” by potentially affecting millions, such as patients with obesity or high cholesterol. 

Additional violations OPDP called out in 2019 include:

  • Failure to present information relating to contraindications, warnings, precautions, and adverse reactions with a prominence and readability reasonably comparable with the presentation of information relating to the benefits.
  • Presentation of certain risk information in direct-to-consumer (DTC) advertisements was undermined by the simultaneous presentation of fast-paced visuals, music, and scene changes that competed for viewers’ attention.
  • Inadequate presentation in TV ads of information relating to the major side effects and contraindications of the advertised drugs in the audio (or audio and visual parts) of the presentation.
  • “Before-and-after” side-by-side visuals that OPDP asserted misleadingly represented that a typical patient would experience similar results, despite lower efficacy in clinical studies.
  • Inadequate disclosure of the full indication and limitations of use associated with the drug as provided in the Indications and Use section of the Prescribing Information.

Continuing focus on pre-approval promotion

Two letters targeted companies’ materials for investigational new drugs, highlighting that “conclusory” representations cannot be made in a promotional context regarding the safety and efficacy of an investigational drug that has not yet been approved, whose safety and efficacy have yet to be established. In recent years, promoting an unapproved drug has been a high area of interest for FDA.

OPDP’s eyeballs are on Facebook, LinkedIn, and YouTube

OPDP sent letters regarding promotional materials found on four companies’ webpages, two print ads (one with associated banners), two television ads (including one that also appeared on social media platforms Facebook and LinkedIn), one direct-to-consumer YouTube video, and one professional email. This shows FDA continues to pay attention to traditional communications vehicles, but is also monitoring digital advertisements and social media to ensure prescription drugs are not being misbranded in these newer platforms.

OPDP’s issuance of ten 2019 letters is slightly up from the seven it issued in 2018, and the five it issued in 2017, and it is on pace with the 11 letters OPDP sent in 2016, and the nine in 2015. While OPDP seems to have moved on from the blistering rate of enforcement letters issued in the pre-2000 years, we can still glean important information about the Agency’s enforcement focus from the letters it issues. If you have any questions about FDA’s advertising and promotion standards for prescription drugs, please contact your Hogan Lovells attorney or any of the authors of this publication.

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