Trump's Memorandum on Pharma DTC Advertising is a Solution in Search of a Problem

By: Ranier Simons, ADAP Blog Guest Contributor

Adding to the growing list of edicts issued by the Trump Administration is a presidential memorandum issued in September 2025 regarding prescription drug advertising. The memorandum was not an executive order; thus, it listed no detailed implementation or specified remedy for a perceived problem that probably doesn’t exist. It simply implied that the U.S. Food & Drug Administration (FDA) has not been effective at “protecting the public” from inappropriate direct-to-consumer (DTC) advertising. The memorandum directs the Commissioner of Food and Drugs to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) prescription drug advertising provisions to ensure pharmaceutical DTC advertising is transparent and non-misleading. While it is laudable to emphasize the need for patient protection, DTC advertising by other industries, including alcoholic beverage companies, also poses significant harm to the public.

Photo Source: BioSpace

In coordination with the release of the presidential memorandum, the FDA also released a press release on the same day (FDA, 2025). The release stated that the FDA would send 100 cease-and-desist letters to pharmaceutical companies using what it described as deceptive ads. Additionally, the release noted the FDA would be initiating rulemaking to close the “adequate provision loophole”, a 1997 FDA regulation regarding disclosures in DTC broadcast advertising. The loophole allowed drug advertisements, particularly DTC broadcast radio and television ads, to be considered compliant if they contained a brief “major risk statement” indicating major side effects and included information directing people to a website or phone number for very detailed drug information. Before 1997, the level of detail required resulted in drug information presentations of the length and breadth of infomercials in order to display a complete safety list of risks and contraindications.

Back in 2023, the FDA had actually already established a final rule specifying advertising requirements to fulfill the major statement requirement in a “clear, conspicuous, and neutral manner” (Craven, 2023). The standards required that:

• The major statement is presented in language and terminology that is consumer-friendly and readily understandable
• Audio information in the major statement is as understandable as audio information in the rest of the ad in terms of volume, articulation, and pacing
• During presentation of the major statement, the ad does not contain audio or visual elements that might interfere with a consumer’s understanding of the content
• During TV ads, the text information is presented in a way that is easy to read
• During TV ads, the major statement is to be presented simultaneously in audio and text, and is shown for long enough to be read easily

Presently, the FDA has issued over 100 untitled letters to various manufacturers regarding specific drug advertisements. The agency lists many of those DTC violation letters on the FDA website under the “untitled letters” and “warning letters” areas. The letters’ claims revolve around a few key ideas. A major complaint is that the advertising makes claims that the cited literature or associated clinical trials do not support. Another purported issue is that the presentation of the subjects indicates a quality-of-life improvement that is not supported by the data. Regarding the presentation, there are letters stating that the on-screen information is too detailed to be read in the brief screen time available. 

Photo Source: US Pharma Marketing

The violation letters are not just targeting patient-facing ads. The FDA is also targeting promotional materials to healthcare professionals (HCP). One letter sent to Amgen Incorporated showed that the Center for Drug Evaluation and Research was not satisfied with the level of detail in the analysis of one of the studies used to support the efficacy and depth of response section of a website dedicated to the drug Imdeltra. The letter complained that outcomes were reported based on a single-arm clinical trial, thus improperly substantiated. A single-arm clinical trial is one in which all subjects receive the same medication under study, without a control or placebo group. A single-arm clinical trial is actually appropriate in several instances. For example, there are some studies conducted where rare diseases are involved; thus, it is unethical to subject participants to placebos for life-threatening conditions (Hembara, 2025). 

The violation letters all state that, due to the stated violation, the distribution of a drug violates the FC&C Act. Thus, an accused entity must file a written response explaining how it will remedy the specifically stated violation or pull a drug from distribution. To date, over 60 enforcement letters have been issued, along with 58 warning letters sent to online pharmacies regarding the promotion of compounded products that seemingly erroneously indicate they are FDA-approved (Propharma, 2025). Presently, there have been no adverse governmental actions in response to any of the letters that have been issued.

The potential final outcome of the FDA’s actions is unclear. No rulemaking has been set regarding the adequate provision loophole. Thus, it is entirely plausible that, at some point, drug manufacturers would have to pull all broadcast DTC advertising in its current form. That would be devastating financially for networks in terms of advertising dollars. Drug manufacturers spent $7.9 billion in television advertising from January to October 2024 (Wolk, 2025). Switching from television to online advertising is not as beneficial for pharmaceutical companies, as older Americans are their audience. Older Americans are heavy consumers of broadcast television and cable news outlets (Wolk, 2025). Thus, if eventually a ban on broadcast DTC advertisements were to occur, networks would take a heavy financial hit.

It also poses a challenge for the network's viewers...patients. Creating artificial barriers has never yielded positive health outcomes, but the presidential memorandum overlooks this for patients. It also artificially targets a single industry while conveniently overlooking or ignoring abuses that truly do exist in television advertising by other industries.

Photo Source: Federal Trade Commission

Conversely, the focus on DTC pharmaceutical advertising in the name of public health ignores the alcohol industry and the food supplement industry. Regarding alcohol, one media data sample estimates that 1.6K companies spent over $1.4 billion on broadcast and digital advertising in 2023, Q4 (Media Radar, 2023). Alcohol advertisements depict a high quality of life and enjoyment for everyone who consumes the beverages. There are no major statements about the adverse medical realities of alcohol consumption. Yet the FDA is not focused on how alcohol ads would indicate that consumption is directly correlated to positive social interactions with no side effects. Alcohol ads also do not have disclaimers to raise concern about the interaction between alcohol and a person’s prescription drugs, health supplements, or contraindicated pre-existing health conditions, or addiction. 

No concrete legal rulings on DTC drug advertising are expected in the near future. The government is not only in a shutdown but is already operating at a diminished capacity, given the administration’s elimination of 3,500 FDA jobs earlier this year (Frank & Glied, 2025). Moreover, any future rulemaking or aggressive penalty pursuit will be followed by lawsuits. Most importantly, bona fide patient harm from DTC pharmaceutical advertising has not been proven. Drug advertising, in some ways, increases patient access by bringing awareness to disease states and therapy modalities. Time will tell whether the FDA's actions are performative politics or a means to a beneficial end.

[1] Craven, J. (2023, November 21). FDA issues new standards for DTC prescription drug ads. Retrieved from https://www.raps.org/news-and-articles/news-articles/2023/11/fda-issues-new-standards-for-dtc-prescription-drug

[2] Frank, R., Glied, S. (2025, May 14). The Trump administration’s NIH and FDA cuts will negatively impact patients. Retrieved from https://www.brookings.edu/articles/the-trump-administrations-nih-and-fda-cuts-will-negatively-impact-patients/#:~:text=The%20Trump%20administration%20has%20made%20unprecedented%20cuts,biological%20products%20*%20Develop%20competitive%2C%20lower%2Dpriced%20products

[3] Hembara, N. (2025, January 13). Single Arm Studies: What Are They & When Are They Used? Retrieved from https://www.allclinicaltrials.com/blog/what-are-single-arm-studies

[4] Media Radar. (2023, December 26). Q4 2023 12 for ‘24 - Alcohol. Retrieved from https://www.mediaradar.com/blog/blog/q4-2023-12-for-24-alcohol.

[5] Propharma. (2025, October 28). FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications. Retrieved from https://www.propharmagroup.com/thought-leadership/insights-fda-2025-enforcement-letters-ccn-standards

[6] U.S. Food & Drug Administration (2025, September 9). FDA Launches Crackdown on Deceptive Drug Advertising. U.S. Department of Health & Human Services. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising

[7]7 Wolk, A. (2025, March 4). Could A Pharma Ad Ban Shake Up The TV Industry? Retrieved from https://www.tvrev.com/news/could-a-pharma-ad-ban-shake-up-the-tv-industry#:~:text=Pharmaceutical%20advertising%20has%20long%20been,and%20they%20aren't%20pretty.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.    

What are 'Major Statements' for Direct-to-Consumer Pharmaceutical Advertisements

By: Ranier Simons, ADAP Blog Guest Contributor

In the United States, it is common to see advertisements for drugs. Ads appear in print magazines, on television, on the radio, on the internet, and mobile devices. In 2022, the pharmaceutical industry spent nearly $17.4 billion on advertising.[1] The majority of this spending is direct-to-consumer pharmaceutical advertisement (DTCPA) spending. Coincidentally, the United States and New Zealand are the only countries in the world allowing DTCPA. Other countries have banned DTCPA because they feel it does more harm than good. In addition to well-established prescription drug advertising regulations, the U.S. Food & Drug Administration (FDA) released a final rule in November of 2023, effective as of May 20, 2024.[2] Companies have until November 20, 2024, to come into full compliance. 

Photo Source: FDA

The new rule is specific to DTCPAs that are delivered in radio or television format, which name a drug and describe what it is used for. This rule focuses on the presentation of the ‘major statement’, which is the explanation of a drug's side effects and contraindications. There are five key standards the rule establishes. Major statements must be delivered in consumer-friendly language; audio information must be understandable; text must be presented clearly, conspicuously, and neutrally; text information must be readable; and ads cannot include distractions.

Requiring statements to be delivered in consumer-friendly language means that information regarding a drug's side effects and contraindications does not contain scientific and medical jargon. Most consumers must easily understand it. The rule’s requirements concerning the audio information are a direct response to the way ads used to appear and sound. Audio must be understandable in terms of volume, articulation, and pacing.[2] Previously, ads, whether on television or radio, would list a long line of side effects and concerns with a rapid cadence and sometimes in a less audible tone than the rest of the advertisement. This is because ads were required to list almost every possible side effect of a medication. The new rules now mean that only the major and most frequent side effects must be stated. They must be articulated in audio that is as clear as the remainder of the advertisement.[2]

With respect to text, the rule explains that textual information must be presented in an appropriate font, positioned in a visually advantageous manner, against an appropriately contrasting background, and appear for a proper duration of time.[2] Regarding distractions, the rule explains that ads cannot contain statements, text, images, or sounds that distract from the communication of the major statement of side effects and contraindications.[2] Most importantly, in terms of transparency, the contents of the major statement have to appear simultaneously in the audio and video portions of television ads, which is referred to as dual-modality.[2]

The new rule, in addition to the longstanding advertisement regulations, is meant to protect consumers and ensure they are not misled about what drugs can and cannot do. It also informs them about a medication’s risks. Many critics feel the new rules do not go far enough, primarily since they do not address the content of the information, only its presentation.

Photo Source: FDA

There are many pros and cons to DTCPA. Advertisements can educate patients about available treatment options, encourage people to seek care, especially regarding underdiagnosed conditions, and improve communication between doctors and patients. Moreover, when someone sees an ad for a drug they are already taking, it can be a reminder to take their medication as well as positively influence how they feel about the medication, which can increase adherence. Negative attributes of DTPCA are it can lead to overuse of some prescription drugs, which increases drug spending, can cause higher utilization of brand name drugs instead of effective lower-cost generics, and can negatively affect the patient-doctor relationship.[3] Consumers may see an advertisement for a drug and demand it from their physician. However, the physician may deny them a particular medication because the physician is knowledgeable of medical reasons why a drug may not be a good fit or actually be harmful. This could affect the trust and communication between a doctor and a patient.

A notable shift regarding DTCPA is regarding drugs to treat and prevent HIV/AIDS. Over the past few years, there has been a recognizable increase in the number of ART-related television, print, radio, and digital ads. In 2021, ads for ART accounted for six percent of total prescription drug ad spend. Gilead Sciences and GSK accounted for almost all of 2021’s pharmaceutical ad spending dedicated to HIV and AIDS.[4] For example, GSK spent all its 2021 Q4 advertising budget buying spots on ABC, A&E, CBS, CNN, Fox, NBC, and the USA network, which was 75% of what the company spent on television ads that year.[4]

ViiV Healthcare, which is majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has had a recognizable presence in television ads since 2017. In 2017, one of its first significant television campaigns was for Triumeq.[5] In 2022, ViiV spent $8.3 million in June alone, on television ads for Dovato. Advertisements for HIV-related drugs on television, in print ads, and digital forms are potentially not just beneficial for drug companies’ bottom lines.[6]

Photo Source: Trend Radars

Antiretroviral drug ads are educational in informing patients of drug options. The science behind treatment for HIV/AIDS is moving at a rapid pace, and many are not aware of all the treatment options available. Advertisements can empower HIV/AIDS patients to have discussions about treatment modalities their doctors may not have presented to them. Additionally, antiretroviral drug campaigns are a kind of social engineering. There are still negative perceptions and public stigma surrounding HIV despite scientific knowledge supporting the concept of undetectable viral load translating into a lack of risk of transmission, or “U=U undetectable = untransmittable.”[6] Many television ads depict subjects who are actual users of the antiretroviral medications, publicly revealing their status. This can add humanity to a disease that remains cloaked in stereotypes and misinformation for many.

Whether in a magazine, a television commercial, a print ad, a YouTube video, or a digital mobile pop-up, pharmaceutical advertisements in the United States are here to stay. There are valid pros and cons. The only way to ensure that the pros outweigh the cons is to monitor and regulate intentionally. Difficulties in the logistics of enforcing governmental regulations can mean slow adoption of and even violation of rules. Optimistically, the efforts of consumers, advocates, and medical professionals can facilitate acceptable and effective pharmaceutical advertisement utilization and execution.

[1] Faria, J. (2023, September 22). U.S. pharmaceutical preparations ad spend 2021-2022. Retrieved from https://www.statista.com/statistics/470460/pharmaceutical-preparations-industry-ad-spend-usa/#:~:text=In%20a%20survey%20of%20representatives,billion%20U.S.%20dollars%20on%20advertising.

[2] FDA. (2023, November 21). 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. Retrieved from https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear

[3] Keller, J., Hauschild, J. (2024, January 10). FDA Issues Final Rule and FAQ Regarding Direct-to-Consumer Drug Advertising. Retrieved fromhttps://www.faegredrinker.com/en/insights/publications/2024/1/fda-issues-final-rule-and-faq-regarding-direct-to-consumer-drug-advertising

[4] Media Radar. (2022, May3). HIV/AIDS Prescription Drug Advertising: Looking Toward the Future. Retrieved from https://mediaradar.com/blog/hiv-aids-prescription-drug-advertising/

[5] Bulik, B. (2017, December 4). ViiV starts 'Moving Forward' into first branded TV ads for HIV treatment. Retrieved from https://www.fiercepharma.com/marketing/viiv-s-first-branded-hiv-tv-ad-stars-real-patients-and-their-stories

[6] Adams, B. (2022, July 11). ViiV wants HIV patients to 'detect this' as it launches new Dovato TV ad. Retrieved from https://www.fiercepharma.com/marketing/viiv-wants-hiv-patients-detect-it-launches-new-dovato-tv-ad

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.