Public Citizen Petitions the FDA To Ban Direct-to-Consumer Advertising of Prescription Drugs

In July 2026, Public Citizen petitioned the Food and Drug Administration (FDA) to ban direct-to-consumer (DTC) advertising of prescription drugs.[1] Our petition argued that the harms of DTC advertisements outweigh any purported benefits. The harms cannot be sufficiently mitigated through existing or updated federal regulations or enhanced FDA enforcement.

Notably, only two developed countries, the United States and New Zealand, allow unfettered DTC advertising of prescription medications. There is no evidence that consumers in countries that ban DTC advertisements have adverse health effects.

Before 1997 the FDA required that DTC advertisements include complete information about a drug’s side effects, contraindications, precautions and warnings.[2] Including detailed information required a substantial amount of airtime, and advertisements on television or radio were rare.

In 1997, however, the FDA loosened these requirements. Advertisers were allowed to omit important information if they included a brief summary with a “major statement” of risks and provided details about the drug’s safety and effectiveness in another format or location, such as a website, a toll-free number, a print insert or through pharmacists or physicians.

The industry quickly capitalized on this regulatory shift. Annual spending on DTC advertising grew from approximately $1.3 billion in 1998[3] to $8 billion in 2024.[4] Online DTC advertisements are all over the internet and frequently appear in social media feeds.

The FDA does not preapprove DTC advertisements. Ads that violate agency standards may air for months or years before warning letters are issued, and warnings are often not followed by stronger enforcement measures.

In September 2025 the FDA announced a “crackdown” on deceptive DTC advertising, including initiating plans for rulemaking and stronger enforcement, with the goal of returning to the pre-1997 environment.[5] A year later, however, the FDA’s efforts have been disappointing. Our petition argues that greater enforcement or strengthening of FDA regulations, with uncertain effectiveness, is not an adequate substitute for a ban on DTC advertising.

Harms of DTC ads

Misleading benefit and risk information

Regardless of whether manufacturers follow FDA guidelines, they are not required to include quantitative benefit data and can therefore mislead patients by overstating benefits and understating risks.[6] Additionally, many advertisements present important drug information using small fonts or strategically placed text, as well as specific word choices that downplay the product’s harms and emphasize its benefits. Online advertising appears to be especially prone to misleading or deceiving consumers.[7]

Emotional manipulation

DTC advertisements often employ emotional manipulation techniques or visual distractions to highlight information about a drug’s benefits while minimizing information about a drug’s risks. For example, a 2018 content analysis of prime-time DTC advertisements aired in 2004 and 2016 across four major television networks found that most advertisements contained positive emotional appeals (94.4% and 94.1%, respectively).[8] Meanwhile, the percentage of factual information presented about the advertised conditions had decreased (from 82.0% in 2004 to 77.4% in 2016), including information about prevalence and risk factors.

Inappropriate prescribing and overdiagnosis

Studies have shown that patients who requested brand-name drugs were substantially more likely to be prescribed the requested drug, even when alternative treatments would have been safer or more appropriate.[9],[10] DTC advertising driving overprescribing or inappropriate prescribing is particularly troubling because new and heavily advertised drugs have later been withdrawn from the market over serious safety concerns. For example, when the COX-2 inhibitor rofecoxib (VIOXX) — which was one of the most heavily advertised drugs while on the market — was withdrawn from the market in 2004, more than 80 million patients had been prescribed the drug. Rofecoxib was associated with thousands of acute myocardial infarctions and sudden cardiac deaths in the United States that might not have occurred otherwise.[11]

Erosion of patient-physician relationship

When DTC advertisements “work,” they do so by interfering with the patient-physician relationship, persuading physicians to prescribe medications they would not have otherwise prescribed.[12] Although physicians have an ethical and professional duty to act in their patients’ best interests, the pressure to prescribe requested medications is substantial, and physicians frequently comply. For instance, according to a 2020 nationally representative survey of 1,744 U.S. adults, 76% of the respondents said they were likely to ask their clinicians about advertised drugs, and 23% stated that they were likely to switch clinicians if they did not receive the requested brand-name drug.[13]

Promotion of low-value medications

DTC advertising disproportionately promotes drugs with limited clinical benefit.[14] For example, a cross-sectional analysis of the 134 highest-selling brand-name drugs in the United States, published in 2023, found that companies spend more on DTC advertising for drugs with lower added clinical value.[15] Moreover, the long-term effectiveness and safety of newly approved — and often heavily advertised — drugs is generally not adequately established at the time of approval.

Economic harms

DTC advertising for prescription drugs also imposes substantial economic burdens on the health care system by driving higher drug spending and shifting state and federal health care expenditures toward drugs that are frequently advertised to consumers. For instance, in 2021 the Government Accountability Office found that the drugs with the highest Medicare spending were also those with the highest DTC advertising expenditures.[16] Of the $560 billion in Medicare Parts B and D spending on drugs between 2016 to 2018, 58% was spent on those advertised directly to consumers.

First Amendment issues

Proponents of DTC advertising argue that a ban would violate the First Amendment. However, DTC advertising is commercial speech, which receives only limited First Amendment protection. Because DTC advertising is often misleading, and because banning it would advance substantial government interests (such as facilitating the ability of patients to make informed medical decisions and curbing unnecessary health care expenditures), the petition argues that a ban would comply with the First Amendment. Experience with DTC advertisements shows that measures short of a ban will not protect the important government and public interests at stake.

What You Can Do

Be aware that DTC advertisements of prescription drugs are designed to market drugs, not to inform and educate patients. More reliable and balanced sources of information are readily available, such as FDA-approved prescribing information and medication guides, available online, as well as information from physicians and pharmacists.
 

References

[1] Public Citizen. Public Citizen petitions the FDA to ban direct-to-consumer advertising of human prescription drugs. July 23, 2026. https://www.citizen.org/article/public-citizen-petitions-the-fda-to-ban-direct-to-consumer-advertising-of-human-prescription-drugs/. Accessed August 3, 2026. 

[2] Donohue J. A history of drug advertising: the evolving roles of consumers and consumer protection. Milbank Q. 2006;84(4):659-699. 

[3] Scott D. The untold story of TV’s first prescription drug ad. STAT. December 11, 2015. https://www.statnews.com/2015/12/11/untold-story-tvs-first-prescription-drug-ad/. Accessed August 3, 2026.

[4] Kravitz RL. Health care ramifications of pervasive direct-to-consumer prescription drug advertising. Annu Rev Public Health. 2026;47(1):479-497. 

[5] Food and Drug Administration. FDA news release. FDA launches crackdown on deceptive drug advertising. September 9, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising. Accessed August 3, 2026. 

[6] Food and Drug Administration. Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements. Guidance for Industry. December 2023. https://www.fda.gov/media/169803/download. Accessed August 3, 2026. 

[7] Sullivan HW, O'Donoghue A, Mannis S, et al. Character-space-limited online prescription drug communications: Four experimental studies. Res Social Adm Pharm. 2022;18(12):4092-4099. 

[8] Applequist J, Ball JG. An updated analysis of direct-to-consumer television advertisements for prescription drugs. Ann Fam Med. 2018;16(3):211-216. 

[9] Mintzes B, Barer ML, Kravitz RL, et al. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ. 2003;169(5):405-412. 

[10] McKinlay JB, Trachtenberg F, Marceau LD, et al. Effects of patient medication requests on physician prescribing behavior: results of a factorial experiment. Med Care. 2014;52(4):294-299. 

[11] Topol EJ. Failing the public health-rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351(17):1707-1909. 

[12] Franquiz MJ, McGuire AL. Direct-to-consumer drug advertisement and prescribing practices: Evidence review and practical guidance for clinicians. J Gen Intern Med. 2021;36(5):1390-1394. 

[13] Sullivan HW, Aikin KJ, Berktold J, et al. Direct-to-consumer prescription drug advertising and patient-provider interactions. J Am Board Fam Med. 2020;33(2):279-283.

[14] Patel NG, Hwang TJ, Woloshin S, et al. Therapeutic value of drugs frequently marketed using direct-to-consumer television advertising, 2015 to 2021. JAMA Netw Open. 2023;6(1):e2250991. 

[15] DiStefano MJ, Markell JM, Doherty CC, et al. Association between drug characteristics and manufacturer spending on direct-to-consumer advertising. JAMA. 2023;329(5):386-392. 

[16] Government Accountability Office. Prescription drugs: Medicare spending on drugs with direct-to-consumer advertising. May 18, 2021. https://www.gao.gov/products/gao-21-380. Accessed August 3, 2026.