FDA Policy/General

Update FDA Social Media Enforcement: Durbin, Braun

David McFarland

— 2 min read
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Senators Dick Durbin (D-IL) and Mike Braun (R-IN) are calling on FDA to “take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics, and to prioritize the protection of children from harmful and inaccurate medical advice.” In a 2/14 letter to FDA commissioner Robert Califf, Durbin and Braun say it appears there are “gaping holes in FDA’s oversight of DTC promotions that are being exploited on social media at the expense of children and parents.”

They raise three issues:

  • FDA has not updated its draft guidance on prescription drug promotion for social media since 2014, while the social media landscape has evolved dramatically with the skyrocketing amount of time that users, particularly children, spend scrolling on platforms and the emergence of platforms such as Instagram, Snapchat, X, and TikTok.
  • telehealth companies appear to be using extensive social media promotion for prescription drugs without adhering to traditional requirements on accuracy, side effect disclosures, and fair balance of risk information; and
  • there has been an explosion of prescription drug promotion by social media influencers, including celebrities, content creators who fail to disclose a financial relationship with a drug’s manufacturer, and those with no financial relationships.

The senators ask for responses to these questions:

  • whether FDA will commit to updating by 12/31 its 2014 prescription drug promotion guidance to reflect the current public health threats and regulatory gaps that exist from the current nature of social media use;
  • whether telehealth companies and others who can prescribe medicines are subject to FDA regulatory requirements for prescription drug ads;
  • why the agency has taken public enforcement action only seven times since 2017regarding content on social media platforms that fail to comply with regulations;
  • list all enforcement actions taken in the last five years involving social media influencers who are paid by a pharmaceutical manufacturer for a promotion regarding a specific prescription drug;
  • whether FDA has enforcement authority covering a third-party social media influencer with no financial relationship with a drug’s manufacturer, distributor, or packer who promotes a prescription drug by name in a social media post falsely or misleadingly;
  • the number of CDER Office of Prescription Drug Promotion staff and CBER Promotional Labeling Branch who are dedicated to social media ads and how this number has changed in the last 10 years;
  • an estimate of the number of staff and associated additional resources needed for the two FDA ad units to adequately oversee social media content;
  • a summary of all relevant FDA research findings on evidence gaps, marketing strategies, trends, key perspectives, vulnerable populations, and other relevant aspects of the social media prescription drug advertising landscape;
  • how the FDA Bad Ad program addresses social media content that fails to adhere to requirements about a given medication;
  • other than the Bad Ad program, how FDA conducts regulatory oversight of social media ads;
  • how FDA engages with the Federal Trade Commission on social media prescription drug ads; and
  • whether FDA supports requiring social media platforms to list all sponsored influencers for prescription drugs in an easily searchable database.

“The threats to children from misleading and unsubstantiated advertisements necessitate action,” the senators tell Califf. “You have called misinformation and disinformation a leading cause of death in the United States, and it is time FDA addresses this challenge.”

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