Direct‐to‐Consumer Advertising

The Academy of Managed Care Pharmacy (AMCP) supports legislative and regulatory measures that ensure direct-to-consumer advertising (DTCA) of prescription drugs serves the public interest by being accurate, transparent, and educational. AMCP supports improving patient engagement through advertising that educates patients on particular diseases and promotes the importance of adherence to prescribed medications. While DTCA can be beneficial in educating people about disease symptoms and possible treatments,^{1, 2} AMCP has significant concerns regarding its frequent misuse as a marketing strategy that prioritizes profit over patient health. The United States is one of only two countries that permit the use of DTCA.³ DTCA often promotes specific prescription medications in ways that can lead to inappropriate patient demand, undermine the provider-patient relationship, and fail to provide important safety and cost information.⁴ 

In 2019, CMS finalized a rule requiring television ads for prescription drugs and biological products to include the product’s list price if Medicare or Medicaid reimbursement is available.⁵ AMCP believes the FDA should similarly take a greater role in ensuring that DTCA sufficiently informs patients about efficacy, safety, and cost, including information about the underlying disease(s), various non-drug treatment options, and the potential risks of using the product. FDA should also develop a uniform disclosure for all DTCA that would advise consumers of the importance of a discussion with their physician to learn about the availability of alternative treatment options that may be more cost-effective, including generics, biologics, and non-pharmacological options. This process would ensure advertisements are truthful, balanced, and fairly present both the benefits and risks of a drug. This transparency is essential for supporting informed healthcare choices, optimizing clinical outcomes, and preventing financial harm to patients. 

AMCP strongly supports requirements for manufacturers to identify the drug's name and its intended uses in DTCA, such as in the November 2023 Final Rule.⁶ AMCP supports FDA’s requirement that DTCA be written in plain language understandable to the ordinary consumer as this helps patients with lower literacy obtain the information they need. Additionally, AMCP supports requirements to present the major side effects and risk information—collectively known as the “major statement”—in a clear and noticeable way, ensuring neutrality in how the information is conveyed. This transparency enables consumers to make knowledgeable healthcare choices and clearly comprehend the impacts of their decisions. Future regulation should expand these requirements to cover all media formats, including online and social media advertisements. In addition to regulatory updates, the FDA has also established a mechanism for the public to report misleading advertisements.⁷ This procedure guarantees that advertisements are truthful, not misleading, and offer a fair representation of both the advantages and risks associated with a drug. 

It is essential to ensure that DTCA enhances health literacy and supports informed decision-making. AMCP encourages Congress and FDA to strengthen oversight to ensure that the practices of DTCA are in line with these objectives.

See also:

AMCP Legislative and Regulatory Positions

Revised by the AMCP Board of Directors, February 2026

Revised by the AMCP Board of Directors, March 2023

Revised by the AMCP Board of Directors, February 2017 

¹Parekh, N and Shrank, WH. “Dangers and Opportunities of Direct-to-Consumer Advertising.” J Gen Intern Med. 2018 May, 33 (5): 586-587. DOI: 10.1007/s11606-018-4342-9.    

²DeFrank, J., Berkman, N., Kahwati, L., Cullen, K., Aikin, K., & Sullivan, H.W. “Direct-to-Consumer Advertising of Prescription Drugs and the Patient Prescriber Encounter: A Systematic Review.” Health Commune. 2020 May;35(6):739-746. doi: 10.1080/10410236.2019.1584781.  

³Sood, N. “Should the Government Restrict Direct-to-Consumer Prescription Drug Advertising?  Six Takeaways on Their Effects.” USC Schaeffer Institute for Public Policy & Government Service. March 2023. Available at https://schaeffer.usc.edu/research/should-the-government-restrict-direct-to-consumer-prescription-drug-advertising-six-takeaways-from-research-on-the-effects-of-prescription-drug-advertising/

⁴“Prescription Drug Advertising.” U.S. Food & Drug Administration. 2019 July. Accessed online: https://www.fda.gov/drugs/information-consumers-and-patients-drugs/prescription-drug-advertising.  

⁵42 C.F.R. 403.1202 (“Any advertisement for any prescription drug or biological product on television (including broadcast, cable, streaming, or satellite) must contain a textual statement indicating the current list price for a typical 30-day regimen or for a typical course of treatment, whichever is most appropriate…”

⁶ 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, 88 Fed. Reg. 80958 (Nov. 21. 2023) (codified at 21 CFR 202). Available at: https://www.govinfo.gov/content/pkg/FR-2023-11-21/pdf/2023-25428.pdf 

⁷ Dumit, Joseph. "Pharmaceutical Witnessing: Drugs for Life in an Era of Direct to Consumer Advertising." The Pharmaceutical Studies Reader. N.p.: John Wiley & Sons, 2015. 35-40. Wiley Blackwell, 2015. Web. 31 Jan. 2017.