FDA Issues Long-Overdue Regulations on Direct-To-Consumer Advertisements for Prescription Medications

On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers.¹ The FDA first issued its proposed rule in 2010, which subsequently went through three public comment periods between 2010 and 2012.² Interestingly, the FDA provided no opportunities for the public to comment on the rule since 2012. The FDA addressed the over 10-year gap between the last comment opportunity and the issuance of the final rule, explaining that it was due in large part to competing demands for limited Agency resources, including repeated natural disasters, the opioid epidemic, and infectious disease outbreaks including Ebola, Zika, and COVID-19.³ The FDA concluded that no material changes have occurred in the fundamental concepts, scientific research, or literature underlying the proposed rule since 2012.⁴

Overall, the FDA received more than 70 submissions from consumers, public interest and consumer groups, trade and industry associations, healthcare providers, and drug firms over the three comment periods.⁵ The FDA characterized the majority of these as providing support for the proposed rule. Other comments suggested that the FDA undertake additional research before finalizing the rule,⁶ that the rule may confuse consumers by emphasizing highly complex medical risk information,⁷ and that it would result in ads being longer in duration.⁸ However, the FDA found none of these comments to be persuasive.

Prior to the rule change, Direct-to-Consumer Advertisements (DTCAs or “ads”) presented on television or radio were required to present a “major statement” in all ads that included the name of a drug and its conditions of use. The major statement informs consumers of the side effects and contraindications of taking the advertised medication.⁹ According to a 2007 amendment to the Federal Food, Drug, and Cosmetic Act, the major statement must be presented in a “clear, conspicuous and neutral manner,” and directed the FDA to issue standards for determining whether a major statement is presented in such a manner.¹⁰ The new regulations are the FDA’s response to the direction it was given by Congress to develop such standards.

The final standards for major statements in ads are as follows:

1. Information in the major statement must be presented in consumer-friendly language and terminology that is readily understandable.
2. The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the ad in terms of volume, articulation, and pacing.
3. In television ads, the information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration to allow it to be read easily.
4. In television ads, the information in text must be formatted such that the information can be read easily.
5. The ad must not include audio or visual elements during the presentation of the major statement that are likely to interfere with comprehension of the major statement.

Of these standards, numbers 2, 3 and 4 may have the largest effect on TV ads. Rule number 2, requiring that the major statement must be spoken in a manner equally understandable as the rest of the ad, including in “pacing,” suggests that the current use of rapid-fire recitations of side effects, common in many television ads, may soon be abolished. Standard numbers 3 and 4, which require the major statement to be shown concurrently in text as well as audio, and that the text must be easy to read, suggests that the total visual content not dedicated to text may need to be reduced if ads are to remain the same length. Overall, it will be interesting to see the effects these new standards have on the content and pacing of upcoming television ads. The new regulations go into effect May 20, 2024, with a final compliance date for all new ads of November 20, 2024.

Editor: Brenden S.Gingrich, Ph.D.

References:

1. 88 FR 80958, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, Federal Drug Agency, Department of Health and Human Services, November 11, 2023. (Available at: https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear#:~:text=This%20final%20rule%20implements%20a,side%20effects%20and%20contraindications%20(major)).
2. https://www.raps.org/news-and-articles/news-articles/2023/11/fda-issues-new-standards-for-dtc-prescription-drug
3. 88 FR 80958 at 80963.
4. Id.
5. Id.
6. Id.
7. Id. at 80968-69.
8. Id. at 80969.
9. Id. at 80958.
10. Id. at 80958-59.