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FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information
Wednesday, December 6, 2023

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule)[1] to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs by firms, which includes manufacturers, packers, and distributors of prescription drugs and all of their representatives, including both individuals and corporate entities (Prescription Drug Firms). The Rule implements a statutory requirement established by the FDA Amendments Act of 2007 that DTC television or radio ads must be formatted to state the name of the applicable drug and its conditions of use and that the major statement relating to side effects and contraindications (Major Statement) is presented in a clear, conspicuous, and neutral manner.[2] The Rule complements longstanding requirements, including risk information in prescription drug ads, setting standards for the manner in which the Major Statement is presented in DTC ads. The Rule further ensures that this risk information is presented effectively, meaning in a way that helps consumers notice, attend to, and understand the applicable drug’s risks.

The Rule is significant for Prescription Drug Firms engaged in promotional DTC ads.   

The Rule provides that the format of the Major Statement “relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.”  The Rule aims to reduce consumer misinformation and biased ads,[3] thereby enabling consumers to make well-informed health care decisions.

Prescription Drug Firms must be aware of five format regulations that are to be implemented to meet the FDA’s goal.

The FDA directs Prescription Drug Firms to adhere to the following standards:[4]

  1. Information is presented in consumer-friendly language;
  2. The Major Statement’s audio information is at least as understandable as the audio information in the overall ad; and
  3. No visual or auditory interference occurs during the presentation of the Major Statement.

Additionally, for television ads, the ads must have:

  1. The Major Statement’s audio information presented concurrently in text; and
  2. The text information must be formatted in an easy-to-read manner.

Stakeholders have concerns regarding FDA’s enforcement of format regulations.

Stakeholders sought clarification on the FDA’s formatting requirements for the Major Statement. Stakeholders questioned if all music and visual media were prohibited during the Major Statement. The FDA replied that it would not categorically ban music or visual media. Instead, it would assess the Major Statement holistically to ensure the clear communication of medical risks to the audience. Stakeholders also expressed confusion regarding the definition of consumer-friendly language. The FDA replied that it would not restrict this standard to a specific reading level to allow flexibility for Prescription Drug Firms advertising complex pharmaceuticals. Lastly, stakeholders questioned if the placement of language mattered within the Major Statement during TV ads. The FDA replied that there was no strict requirement for placement of text, as the FDA would view the ad — as a whole — for clear and conspicuous presentation of risks.

The Rule becomes effective six months after its publication date.

The Rule will become effective on May 20, 2024 and will require Prescription Drug Firms undertaking DTC to be compliant by November 20, 2024. This means that Prescription Drug Firms will have about one year to ready themselves and modify their ads to align with the updated requirements.

Prescription Drug Firms must comply with DTC format regulations for ads.

The Rule’s Major Statement format requirements expand existing regulatory safeguards for consumer protection. The FDA aims to enable consumers to make well-informed health care decisions by mitigating the spread of misinformation. As such, Prescription Drug Firms must devise and execute a new strategy in the coming year to adjust their media practices to clearly present side effects and contraindications within their ads.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.

[1] Proposed rule was first published in 75 Fed. Reg. 15376 (March 29, 2010).

[2] 88 Fed. Reg. 80958 (Nov. 21, 2023).

[3] Prescription drug ads are required to contain a fair balance of risk and benefit information to establish neutrality. 21 C.F.R. §202.1(e)(5)(ii).

[4] These standards will be included within 21 C.F.R. §202.1(e)(1).

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