New FDA Rules for Risk Information in Direct-to-Consumer Advertisements for Prescription Drugs

In November 2023, the Food and Drug Administration (FDA), after years of delay, issued a final rule about the disclosure of risk information in television and radio direct-to-consumer advertisements of prescription drugs.[1] The rule was originally proposed in March 2010, as discussed in a recent issue of Worst Pills, Best Pills News.[2]

The final rule, which takes effect on May 20, 2024, establishes five standards for what is known in regulatory parlance as the “major statement,” in which direct-to-consumer prescription drug advertisements must disclose the product’s major adverse effects and contraindications. “Independently and collectively,” the standards are meant to ensure that the major statement is “presented in a clear, conspicuous, and neutral manner,” as already required by law. The standards are:

1. The information 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.
3. In ads in TV format, 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 ads in TV format, 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 the comprehension of the major statement.

The final rule is important because of the unique situation for pharmaceutical advertising in the United States, which, aside from New Zealand, is the only country that even permits drug manufacturers to advertise to consumers. Each year, pharmaceutical companies spend billions of dollars on such drug commercials, promoting new medications that are frequently costly and of uncertain benefit as compared to other treatments. This creates demand for products which then increases health care costs.

The five standards seem reasonable, as is the FDA’s intent. The goals are for the ads to “convey a truthful and non-misleading net impression about the advertised drug,” and for consumers to be “better informed when they participate in healthcare decision making.”

Now that the FDA has finalized the standards, the agency must enforce them. Phrases in the standards such as “consumer-friendly language,” “readily understandable,” “sufficient duration,” and “are likely to interfere” are open to interpretation. If drug manufacturers seek to push the boundaries of the standards, the FDA must be willing to push back with prompt enforcement actions. The agency should also conduct or fund research to assess the effects of the final rule on the quality of the advertisements.
 

References

[1] Food and Drug Administration, Department of Health and Human Services, 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. Final rule. Federal Register 2023;88(223)80958-80984. November 21, 2023. https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear. Accessed December 2, 2023.

[2] Improving risk information in direct-to-consumer advertisements for prescription drugs. Worst Pills, Best Pills News. October 2023. https://www.worstpills.org/newsletters/view/1557. Accessed December 2, 2023.