Patients as Consumers: Reflections on the FDA’s New Rule on Direct-to-Consumer Advertising

INTRODUCTION

In November 2023, the Food and Drug Administration (FDA) announced a new rule on direct-to-consumer advertising (DTCA) of prescription drugs that calls for a more balanced and comprehensive presentation of potential risks.¹ The rule, which went into effect in May 2024 (compliance date: November 20, 2024), will require TV and radio advertisements to communicate the risks or contraindications of a drug (i.e., the “major statement”) in a “clear, conspicuous, and neutral manner,”¹ with the goal of making this information more accessible to, and accurately understood by, consumers. This rule comes after a large body of research demonstrating that DTCA employs marketing strategies that minimize the risks associated with the advertised drug.^2-5 While this new policy holds promise for consumers, the “educational” value of these ads will likely be limited if historical challenges in enforcement are not addressed. Furthermore, the rule’s potential to create a more informed consumer needs to be evaluated within the broader ethos of marketing, which can shape consumers’ expectations regarding drug safety and effectiveness.

Drug Marketing in the U.S.

DTCA is part of a broader strategy to generate sales of pharmaceuticals by increasing product demand through prompting the consumer to seek care (i.e., requesting a prescription from their provider).⁶ DTCA is only permitted in the U.S. and New Zealand (among high-income countries), although companies have lobbied to overturn bans in other nations.⁷ Exposure to DTCA is widespread among Americans; in 2022, drug companies spent $8.1 billion on advertising.⁸

DTCA influences decisions that consumers make about their healthcare. There is substantial literature that shows that DTCA exposure prompts information-seeking,⁹ prescription drug requests,¹⁰ and, in some cases, physician-switching following drug request refusal.¹¹ Spending on prescription drug advertising has been linked to increases in consumer spending on medications,¹² suggesting that DTCA contributes to rising drug costs.¹³ DTCA is one of the most common ways that Americans receive health information;⁷ Americans are exposed to approximately 30 hours of DTCA annually, which is significantly longer than the average person spends in a healthcare setting each year.¹⁴ While increased information-seeking and requesting a prescription can certainly be beneficial for some patients, there is limited evidence supporting the notion that behaviors associated with exposure to DTCA translate into greater access to clinically-appropriate care.¹⁵

What is the New FDA Rule?

The new rule on DTCA builds on existing provisions that regulate the presentation of risk information and further clarifies the requirements for the “major statement” in TV and radio ads.¹ Specifically, the FDA now requires advertisements to: (1) Use language and terminology that is consumer friendly and readily understandable; (2) Use audio that is as understandable as audio information in the rest of the advert in terms of volume, articulation, and pacing; (3) Refrain from using audio or visual elements that might interfere with a consumer’s understanding of the content during the major statement of the advert; (4) Use text that is easy to read; and (5) Present the major statement simultaneously in audio and text for long enough to be read easily (i.e., “dual modality”). Table 1 further illustrates the standards adopted with the ruling and highlights the specific requirements to risk presentation that the FDA outlines. These changes aim to ensure that DTCA “convey(s) a truthful and nonmisleading net impression about the advertised drug, including its risks.”¹

Table 1.

Specific Presentation Requirements for the Standards Adopted With the FDA Rule

FDA Standards	Specific Presentation Requirementsa
Standard #1: Information is presented in language that is readily understandable by consumers	Requires that advertisers must avoid medical or technical terms and instead utilize “everyday” words (e.g., “syncope” vs. “fainting”) Discourages against the use of “vague terms or explanations that are readily subject to different interpretations.” For example, when 50% of patients report a certain side effect, use words like “half” rather than “some” to describe these patients
Standard #2: Audio information is understandable in terms of the volume, articulation, and pacing used	Requires that “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 the volume, articulation, and pacing used” Requires that “(r)isk information must be presented at a pace that allows the audience to hear and process it” Discourages against tactics that may reduce consumer comprehension, such as decreasing the volume during the major statement or presenting the audio in a too fast or “inarticulate” manner
Standard #3: (T)he major statement is presented concurrently using both audio and text (i.e., dual modality)	Directs that dual modality may be achieved in the following ways: “(1) either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays a verbatim complete transcript of the corresponding audio; and (2) the text is displayed for a sufficient duration to allow it to be read easily. For the purposes of this standard, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio”
Standard #4: Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily	Requires that there must be “sufficient contrast” between the text and the background (e.g., black text on a white background) Requires that the text must be placed “in a manner that allows it to be easily read” (e.g., text is parallel with the base of the ad) Discourages against the use of tactics such as “small visual superscript” that may be more difficult for consumers to engage with Clarifies that “significant duration” is encompassed by the dual modality requirement (Standard #3; i.e., the text display begins at the same time and ends at approximately the same time as the corresponding audio)
Standard #5: The advertisement does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension of the major statement	Rather than categorically prohibiting specific distracting elements (e.g., scene changes or music), the FDA is adopting a more holistic approach to this standard in which they will evaluate whether the elements of a given advertisement interfere with viewer comprehension

^aThese presentation requirements are a combination of the Proposed Standards (2010) and the Final Standards (2023). In cases where a requirement from the Proposed Standards was changed in the Final Standards, the details from the Proposed Standards were omitted from the table.

Why Was a New Rule Needed?

Through various marketing tactics, DTCA can shape consumer expectations of the efficacy and safety of medications. Existing federal regulations target deceptive advertising by prohibiting adverts that are “false, lacking in fair balance, or otherwise misleading,” which encompasses not only factually inaccurate claims but also suggestive claims or partial truths.¹⁶ This “fair balance” requirement calls for a balanced presentation of drug risks in comparison to the benefits to ensure adequate consumer understanding of risks.¹⁷ However, these past rules are often followed in a manner more in step with the “letter of the law” than the “spirit of the law.” Indeed, empirical research shows that even while potentially satisfying the “fair balance” requirement, DTCA utilizes tactics that inhibit viewer comprehension (e.g., positive imagery, fast-paced voice-overs)³ in a manner that systematically minimizes the risks associated with a drug. Content analyses of DTC television advertisements show that images during the major statements tend to contain more visual complexity, positive imagery, and movement compared with other parts of the advert,^3-5 which is linked to both poorer recall and reduced comprehension of risk information,⁴ as well as increased perceived benefit and positive affect about the drug.¹⁸ DTCA often utilizes strong emotional appeals and depicts improvements in quality of life (e.g., engagement in recreational activities),² which can overemphasize drug effectiveness. By downplaying risk information and emphasizing symptom relief, these adverts promote the expectation that a drug will be net-beneficial for consumers, although these expectations may vary by individual characteristics (e.g., skepticism). In sum, there is significant economic incentive for manufacturers to portray products in a positive light,¹ which empirical research shows can translate into marketing that does not clearly communicate a drug’s risk to consumers. By targeting misleading depictions of drug risks in the major statement, the new FDA rule seeks to create a disincentive to this practice.

Strengths and Limitations of the New Rule

Part of the FDA’s mandate is to ensure that consumers can adequately understand medication risks and benefits so they can appropriately weigh that information in the context of their own health (e.g., other medications they are taking, comorbidities, drug allergies).¹ Notably, the emphasis on dual modality (Standard #3) in the new rule is a promising step in promoting consumer understanding. Researchers have found that dual modality improves recall and comprehension of drug risk information in DTC adverts.¹⁹ Dual modality may also benefit consumers with hearing or language impairments. For example, presenting information simultaneously in visual and auditory formats improves comprehension for people with aphasia.²⁰

While dual modality is a promising change, the rule does not prevent adverts from presenting visual risk information with auditory non risk information (or vice versa), which can decrease consumer recall and risk recognition.¹⁹ Although the FDA provides requirements on how auditory and textual information should be presented (Standards #1 and #2), this language is subjective and open to interpretation (e.g., “consumer-friendly”), which could result in ambiguity when these regulations are implemented. This is especially relevant to Standard #5, which prohibits audio and visual representations of drug attributes that would “interfere with comprehension,” which is difficult to enforce because the rule does not specifically prohibit or limit specific types of representations (e.g., positive imagery, upbeat music). This lack of specificity could impact the effectiveness of the new dual modality requirement; Sullivan et al.²¹ found that use of distracting elements (e.g., scene changes) in DTCA negated any positive associations between dual modality and retention of risk information.

The benefits of these standards to consumers may also be limited by the increasingly diverse ways that consumers interact with prescription drug marketing. The FDA standards apply to DTCA in “TV and radio format(s),” however, it remains unclear how this rule applies to online and social platforms. The FDA distinguishes between TV and other forms of video advertising, and format restrictions of online outlets (e.g., character limits, whether the advert can be partially skipped or must be viewed in its entirety) affect the approaches marketers use on these platforms.²² Regulations have not kept pace with the expansion of online advertising; the FDA last updated its guidance for marketing in online and social media settings in 2014, and demand for DTCA on these outlets is growing rapidly and without adequate regulation.²³

Limitations Within the Broader Context of DTCA

Irrespective of the strengths and limitations of the rule itself, this policy does not address other underlying factors that stem from the broader marketing environment in which DTCA operates which can mislead consumers. DTCA only informs consumers about recently approved, on-patent drugs, which are not representative of all available treatments (e.g., generics). Additionally, a 2023 study by DiStefano et al.²⁴ found that a majority (68%) of the most-advertised drugs have low added clinical-benefit compared with similar medications, which suggests that DTCA disproportionately informs consumers about products that clinicians may be less likely to prescribe. Similarly, the new rule does not impact strategies that marketing campaigns use in DTCA, such as targeting specific demographics (e.g., older adults).¹⁴ While all FDA-approved medications must have a demonstrated clinical efficacy that outweighs associated risks, these advertisements are designed to leverage conditioned expectancies that taking a name-branded medication will result in symptom improvement.²⁵

Finally, the American public holds several misconceptions about DTCA that benefit pharmaceutical manufacturers. Prior research found that many Americans (43%) believe that drugs advertised on TV must be “completely safe” to be advertised,²⁶ even though there have been multiple, highly publicized withdrawals of heavily advertised drugs (e.g., rofecoxib). Additionally, Sullivan et al.²⁷ found that a large proportion of consumers believe that the FDA approves either the entirety (31%) or components (22%–41%) of the advert prior to dissemination. In reality, the FDA uses a “case-by-case” approach to determine whether a given advert is misleading, and then only at the point of public release.¹⁷ As a consequence, while the rule may help consumers attend to the risks presented in the adverts, it fails to address other factors that lead consumers to overestimate the efficacy and safety of advertised drugs.

Future Challenges in Implementation

Historical limitations in the FDA’s enforcement of advertising regulations have not been removed by the advent of this new rule. As required by federal regulation, all DTC advertisements must be sent to the FDA for review at time of dissemination.¹⁷ However, only a limited number of these advertisements are reviewed annually and research shows that the FDA lacks a systematic approach in its evaluation of DTCA claims.²⁸ Indeed, the number of citations the FDA has issued for misleading advertisements has decreased over time, with no indication that this decline is due to industry-driven self-improvement in drug advertising.⁷ Since 2002, the warning letters issued by the FDA regarding DTCA must undergo additional internal reviews, which has slowed the process considerably.²⁸ It is important to note that many limitations in FDA oversight stem from a lack of resources. In the 2025 budget, Congress appropriated $7.2 billion to the FDA, of which $23.5 million will go to the Center for Drug Evaluation and Research which oversees DTCA (among other responsibilities).²⁹ In comparison, the pharmaceutical industry spent $8.1 billion on DTCA in 2022. The FDA’s regulatory authority could be further limited by the recent Supreme Court rulings (e.g., the over-turning of the Chevron ruling in June 2024)³⁰ that weaken the authority of federal agencies to interpret ambiguous regulations.

CONCLUSION

DTCA is an example of the complex ways in which public health, private industry, health care providers, and consumers/patients intersect. While DTCA may have some benefits regarding health education (e.g., informing consumers about available treatments),¹⁵ the primary goal remains to persuade rather than to inform. With this new policy, the FDA seeks to improve the educational value of prescription drug advertisements by rebalancing the presentation of potential benefits and risks. Collectively, these changes may help inform consumers about the risks of a given drug and thus enhance their healthcare decision-making. However, this rule is limited by its subjective language which, as history indicates, companies are likely to interpret in ways that enhance sales. The rule also faces numerous challenges in implementation and enforcement; how recent events (i.e., Chevron ruling) will impact the ability of the FDA to enforce these changes remains to be seen. Engagement with consumer and patient groups, the audience of DTCA, will be essential in meeting the goals of the revised rule to educate consumers and enable them to make more informed decisions about their health.