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Thirteen years ago, on March 29, 2010, the Food and Drug Administration (FDA) proposed a rule about the disclosure of risk information in television and radio direct-to-consumer advertisements of prescription drugs.[1] In 2023, a rule[2] is at long last under review by the Office of Management and Budget (OMB).[3] If the OMB allows the regulation to be finalized — as of mid-September 2023, it was still being reviewed — the presentation of information about the adverse effects and...
Thirteen years ago, on March 29, 2010, the Food and Drug Administration (FDA) proposed a rule about the disclosure of risk information in television and radio direct-to-consumer advertisements of prescription drugs.[1] In 2023, a rule[2] is at long last under review by the Office of Management and Budget (OMB).[3] If the OMB allows the regulation to be finalized — as of mid-September 2023, it was still being reviewed — the presentation of information about the adverse effects and contraindications of drugs advertised directly to consumers should improve. For years, Public Citizen’s Health Research Group has urged the FDA to promptly issue this “long-overdue final rule.”[4]
The United States is unique because, aside from New Zealand, it is the only country that even permits drug manufacturers to advertise to consumers. Each year, pharmaceutical companies spend billions of dollars on drug commercials, advertising medications that are frequently expensive and of questionable benefit as compared with other treatments. For example, the Government Accountability Office reported in 2021 that of $560 billion that Medicare Parts B and D and beneficiaries spent on drugs from 2016 to 2018, $324 billion (58%) was spent on advertised drugs.[5] Among the top 10 drugs for Medicare spending were four of the top 10 drugs in advertising spending in 2018. Another study found that from 2015 to 2021, fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated by independent health technology assessment agencies as “having high therapeutic value,” which the researchers defined as “providing at least moderate improvement in clinical outcomes compared with existing therapies.”[6]
The issue in the proposed FDA rule is what is known in regulatory parlance as “the major statement,” in which prescription-drug advertisements presented through media such as television and radio must disclose the product’s major adverse effects and contraindications. The major statement is already required by law to present risk information “in a clear, conspicuous and neutral manner.” The rule would revise the FDA’s regulations to reflect the legal requirement as well as establish “standards for determining whether the major statement in these advertisements is presented in the manner required.”[7] The detail of the final rule is what will matter, however. Will current FDA requirements for risk disclosure be maintained? Will risk information be required to be presented at the same time in both audio and visual formats? Will potentially distracting imagery and sounds — either musical or nonmusical — be banned? Will the serious adverse effects and contraindications of drugs be appropriately highlighted?[8]
The FDA has had more than 13 years to develop a rule that is up to the task of markedly improving direct-to-consumer prescription-drug advertisements. We should know soon whether the wait was worth it, or whether consumers will still be waiting for the advertisements to improve.
References
[1] Food and Drug Administration. Direct-to-consumer prescription drug advertisements: Presentation of the major statement in television and radio advertisements in a clear, conspicuous, and neutral manner. proposed rule. March 29, 2010. https://www.regulations.gov/document/FDA-2009-N-0582-0001. Accessed August 22, 2023.
[2] Department of Health and Human Services. Direct-to-consumer prescription drug advertisements: Presentation of the major statement in a clear, conspicuous, neutral manner in advertisements in television and radio format. Spring 2023. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=0910-AG27. Accessed August 22, 2023.
[3] Wilkerson J. More regulation could be coming for drug ads. Stat. August 8, 2023. https://www.statnews.com/2023/08/08/regulation-drug-ads/. Accessed August 22, 2023.
[4] Public Citizen. Comments on Knowledge Ecology International’s August 3, 2020, citizen petition requesting the Food and Drug Administration to issue a rule banning the use of background music During the presentation of the risks in direct-to-consumer drug advertising; docket no. FDA-2020-P-1725. October 27, 2020. https://www.citizen.org/wp-content/uploads/2553.pdf. Accessed August 22, 2023.
[5] Government Accountability Office. Prescription drugs: Medicare spending on drugs with direct-to-consumer advertising. June 17, 2021. https://www.gao.gov/assets/gao-21-380.pdf. Accessed August 22, 2023.
[6] Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic value of drugs frequently marketed using direct-to-consumer television advertising, 2015-2021. JAMA Netw Open. 2023:6(1): e2250991.
[7] Direct-to-Consumer Prescription Drug Advertisements: Presentation of the major statement in a clear, conspicuous, neutral manner in advertisements in television and radio format. Spring 2023. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=0910-AG27. Accessed August 22, 2023.
[8] Public Citizen. Comments on Knowledge Ecology International’s August 3, 2020, citizen petition requesting the Food and Drug Administration to issue a rule banning the use of background music during the presentation of the risks in direct-to-consumer drug advertising; docket no. FDA-2020-P-1725. October 27, 2020. https://www.citizen.org/wp-content/uploads/2553.pdf. Accessed August 22, 2023.
