Fact Sheet : Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies

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In 1997, the FDA established a loophole that has enabled pharmaceutical companies to run direct-to-consumer (DTC) advertisements without fully disclosing information on side effects or patient harm. The explosion of DTC pharmaceutical advertising following 1997 has led to (1) public deception from patient confusion, (2) patient harm via inappropriate demand for medications and misalignment of therapeutic choices with actual patient needs, and (3) harm to the public finances via misallocation of healthcare resources, including government spending.

The Trump administration is taking action to return to the pre-1997 status quo by engaging in FDA rule-making to close the “adequate provision” loophole to ensure risk disclosure, and stepping up enforcement action of DTC pharmaceutical ads to ensure companies are fulfilling their legal duty to disclose medical information to enable patients to make an informed decision.

What the FDA is Doing

  1. Rulemaking to remove the 1997 “Adequate Provision” Loophole, which has enabled pharmaceutical companies to withhold vital safety information in advertisements.
  2. Aggressive enforcement of DTC violations.
  3. Close digital loopholes by expanding regulatory oversight to encompass social media promotional activities.

Detail on this Action

  • Removing “Adequate Provision” Loophole to Ensure Informed Patient Consent:
    • The FDA is initiating a rulemaking process to eliminate the “adequate provision” loophole that allows pharmaceutical advertisements to hide safety information by placing it in another format or location.
    • Until 1997, pharmaceutical ads were required to report full contraindications, boxed warnings, and common precautions in advertisement. During this time, pharmaceutical broadcast ads were rare because of the time it would take to read safety information.
    • In 1997, the FDA established a loophole that allows companies recite a vague “major-risk statement” and then point viewers to a website, toll-free number, or print insert for more complete information.
    • This loophole – which denies patients vital safety information required for them to make an informed decision – has had a clear negative impact on public health.
    • The action simply returns to the status quo policy pre-1997. It requires the presentation of factual and uncontroversial statements which are already legally required to be communicated in drug advertising; goes directly to the core government interests of protecting the public from deception and protecting public health—as supported by voluminous evidence of public harm under the current system; and does not unduly burden advertisers, by preserving their right to engage in commercial speech under the standards that existed prior to 1997.
  • Additional Enforcement Action:
    • The FDA will begin aggressive enforcement of DTC violations.
      • Enforcement letters plummeted from over 130 annually in the late 1990s to just three in 2023, while pharmaceutical companies spent $369.8 million to entice consumers on social media advertising in 2020 alone.
      • FDA will send a letter to every single sponsor of an approved drug or biologic (several thousand companies) warning them that the Agency is no longer asleep at the wheel, putting them on notice that FDA will be actively enforcing violations of the law, and directing them to remove all non-compliant promotional materials from the market.
      • FDA will simultaneously issue dozens of enforcement letters related to false and misleading advertising, which makes the drug at issue misbranded. FDA’s actions here will be based on its existing authority, though the Agency will take a more expansive reading of its authorities in contrast to the overly cautious approach taken by previous administrations.
      • If these actions do not sufficiently alter DTC advertising behavior, FDA will continue enforcement activity and will return to the 1990s paradigm of issuing hundreds of enforcement letters each year.
    • The FDA will close digital loopholes by expanding oversight to encompass all social media promotional activities including:
      • Influencer partnerships and sponsored content across all platforms.
      • Algorithm-driven targeted advertising and “dark ads.”
      • AI-generated health content and chatbot interactions.
      • Platform-specific promotional strategies designed to evade detection.
      • Emerging digital technologies and promotional methods.

The lack of appropriate patient safety information in direct-to-consumer pharmaceutical ads has directly led to negative health and economic impacts:

  • Health impacts and Patient Confusion:
    • Prescription drug use among Americans increased from 39% (1988-1994) to 49.9% (2017-2020) in the last 30 years.[ii]
    • A newborn male in 2019 can expect to spend 47.1% of their life on prescription drugs, while newborn females can expect to spend 58.2% of their life on prescription medications.[iii]
    • An early landmark study found that when patients requested advertised drugs, physicians were ambivalent about the clinical appropriateness in many cases yet still wrote the prescription.[iv] Some of the authors went on to demonstrate that physicians are 17 times more likely to prescribe drugs specifically requested by patients, with many reporting pressure to maintain patient satisfaction scores even when prescriptions are clinically inappropriate.[v]
    • DTC campaigns are translating into measurable, misdiagnoses of ADHD and clinically unnecessary use of Adderall.[vi]
    • A 2021 systematic review of observational and experimental studies concluded that DTC advertising increases overall prescription requests, boosts the likelihood that a clinician will prescribe, and raises rates of inappropriate use.[vii]
    • Brief exposure to statin commercials raised the odds of low-risk patients being diagnosed with high cholesterol by 16-20% and starting statins by 16-22%.[viii]
    • A 2024 scoping review of DTC video ads judged 62% as “poor scientific quality,” with just 32% “useful.” 48% were “misleading,” and 34% were “potentially harmful.”[1]
    • A content analysis of DTC advertisements revealed that only a minority of ads presented factual claims about the condition’s mechanism of disease (25%), risk factors of the condition (16%), or prevalence (16%), while 94% employed positive emotional appeals—not the basis for rational healthcare decision making.[2]
    • Direct to consumer advertising generally promotes conversations with a provider that a patient may overly emphasize medication-based solutions at the expense of equally effective lifestyle interventions that may yield comparable benefits. [xv],[ix]
  • Financial impacts:
    • The top ten pharmaceutical companies spent a combined $13.8 billion on advertising and spending in 2023.
    • To demonstrate how DTC advertising drives market demand and healthcare expenditures, the Congressional Budget Office estimated in fall 2024 that a 10% increase in DTC advertising is associated with a 1 to 2.3% increase in drug spending.[xvi]
    • Patients in regions with high DTC drug advertising were 40% more likely to switch to heavily promoted drugs without clinical benefit, adding $400 per patient annually.[xi],[xii]
    • Many providers lack sufficient understanding of FDA drug and device regulatory processes and tend to overly rely on drug / device approval without reviewing or fully understanding underlying data.[xiii] Resultingly, pharmaceutical companies often invest billions in promoting drugs with lower therapeutic value.[xiv],[xv]

Endnotes

[1] Mor, J., Kaur, T., Menkes, D. B., Peter, E., & Grundy, Q. (2024). Pharmaceutical industry promotional activities on social media: a scoping review. Journal of Pharmaceutical Health Services Research, 15(4). https://doi.org/10.1093/jphsr/rmae022

[2]  Applequist, J., & Ball, J. G. (2018). An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Annals of family medicine, 16(3), 211–216. https://doi.org/10.1370/afm.2220

[i]  Kaphingst, K. A., DeJong, W., Rudd, R. E., & Daltroy, L. H. (2004). A content analysis of direct-to-consumer television prescription drug advertisements. Journal of health communication, 9(6), 515–528. https://doi.org/10.1080/10810730490882586

[ii]  FastStats. (2024, November). Cdc.gov. https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm?

[iii]  Ho J. Y. (2023). Life Course Patterns of Prescription Drug Use in the United States. Demography, 60(5), 1549–1579. https://doi.org/10.1215/00703370-10965990

[iv]  Mintzes, B., Barer, M. L., Kravitz, R. L., Kazanjian, A., Bassett, K., Lexchin, J., Evans, R. G., Pan, R., & Marion, S. A. (2002). Influence of direct to consumer pharmaceutical advertising and patients’ requests on prescribing decisions: two site cross sectional survey. BMJ, 324(7332), 278–279. https://doi.org/10.1136/bmj.324.7332.278

[v]  Mintzes, B., Barer, M. L., Kravitz, R. L., Bassett, K., Lexchin, J., Kazanjian, A., Evans, R. G., Pan, R., & Marion, S. A. (2003). How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ : Canadian Medical Association journal, 169(5), 405–412.

[vi]  Menkes, D. B., Mintzes, B., & Lexchin, J. (2024). Direct-to-consumer advertising: a modifiable driver of overdiagnosis and overtreatment. BMJ Evidence-Based Medicine, 29(6), 423–425. https://doi.org/10.1136/bmjebm-2023-112622

[vii]  Franquiz, M. J., & McGuire, A. L. (2021). Direct-to-Consumer Drug Advertisement and Prescribing Practices: Evidence Review and Practical Guidance for Clinicians. Journal of general internal medicine, 36(5), 1390–1394. https://doi.org/10.1007/s11606-020-06218-x

[viii]  Niederdeppe J, Byrne S, Avery RJ, Cantor J. Direct-to-consumer television advertising exposure, diagnosis with high cholesterol, and statin use. J Gen Intern Med. 2013 Jul;28(7):886-93. doi: 10.1007/s11606-013-2379-3. Epub 2013 Mar 6. PMID: 23463454; PMCID: PMC3682042.

[ix]  Parekh, N., & Shrank, W. H. (2018). Dangers and Opportunities of Direct-to-Consumer Advertising. Journal of general internal medicine, 33(5), 586–587. https://doi.org/10.1007/s11606-018-4342-9

[x]  Kaiser Family Foundation. (2003, June). Impact of Direct-to-Consumer Advertising on Prescription Drug Spending. https://www.kff.org/health-costs/impact-of-direct-to-consumer-advertising-on-prescription-drug-spending/

[xi]  Hansen, R. A., Schommer, J. C., Cline, R. R., Hadsall, R. S., Schondelmeyer, S. W., & Nyman, J. A. (2005). The association of consumer cost-sharing and direct-to-consumer advertising with prescription drug use. Research in social & administrative pharmacy : RSAP, 1(2), 139–157. https://doi.org/10.1016/j.sapharm.2005.03.002

[xii]  Hansen, R. A., Shaheen, N. J., & Schommer, J. C. (2005). Factors influencing the shift of patients from one proton pump inhibitor to another: the effect of direct-to-consumer advertising. Clinical therapeutics, 27(9), 1478–1487. https://doi.org/10.1016/j.clinthera.2005.09.006

[xiii]  Dhruva, S. S., Kesselheim, A. S., Woloshin, S., Ji, R. Z., Lu, Z., Darrow, J. J., & Redberg, R. F. (2024). Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey. Health affairs (Project Hope), 43(1), 27–35. https://doi.org/10.1377/hlthaff.2023.00466

[xiv]  Patel, N. G., Hwang, T. J., Woloshin, S., & Kesselheim, A. S. (2023). Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA network open, 6(1), e2250991. https://doi.org/10.1001/jamanetworkopen.2022.50991

[xv]  DiStefano, M. J., Markell, J. M., Doherty, C. C., Alexander, G. C., & Anderson, G. F. (2023). Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising. JAMA : The Journal of the American Medical Association, 329(5), 386–392. https://doi.org/10.1001/jama.2022.23968

[xvi]  Congressional Budget Office. (2024, October 4). Alternative Approaches to Reducing Prescription Drug Prices. Congressional Budget Office. https://www.cbo.gov/publication/60812

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