Presidential Memorandum on DTC prescription drug advertising signals increased focus on social media promotion

President Donald Trump signed a Presidential Memorandum on September 9, 2025 directing the Secretary of Health and Human Services (HHS) to ensure transparency and accuracy in direct-to-consumer (DTC) prescription drug advertisements. The Memorandum, which was not characterized as an Executive Order, also directs the Food and Drug Administration (FDA) to take action to enforce existing prescription drug advertising laws to ensure that DTC ads are truthful and not misleading.

A fact sheet accompanying the Presidential Memorandum focuses on social media, noting that DTC advertising can mislead the public about the full risks and benefits of a drug. In response to the Memorandum, FDA issued a press release indicating that it is sending “thousands” of letters to industry warning pharmaceutical companies to remove misleading advertisements and that it would be issuing around 100 cease-and-desist letters to companies it finds to have deceptive advertisements.

In this alert, we provide the legislative and policy background for these developments, a summary of the Memorandum and related FDA communications, and key takeaways for companies.

Background

The Memorandum follows several months of legislative activity and concerns by the Make America Healthy Again (MAHA) Commission regarding the influence of DTC advertising on prescribing patterns and overuse of certain prescription drugs in children and adolescents.

Legislative activity

Interest in DTC advertising restrictions peaked in the last year with the introduction of several bills focused on DTC prescription drug advertising. In the 118th Congress, Senator Dick Richard Durbin (D-IL) sponsored the Protecting Patients from Deceptive Drug Ads Online Act (S.5040), which would have imposed civil monetary penalties on social media influencers and telehealth companies that engaged in false or misleading advertising. In the same legislative session, Senator Josh Hawley (R-MO) and Representative Gregory Murphy (R-NC) sponsored the No Handouts for Drug Advertisements Act (S.1785 and H.R.3010, respectively), which would have eliminated the tax deduction expenses relating to DTC advertising of prescription drugs.

On June 12, 2025, Senator Bernie Sanders (I-VT) introduced a bill entitled the End Prescription Drug Ads Now Act (S.2068) in the US Senate, and on July 24, 2025, Representative Jerrold Nadler (D-NY) (H.R.4605) introduced a counterpart bill in the US House of Representatives. The bill, if enacted, would ban DTC prescription drug advertising.

On July 15, 2025, during the Senate Homeland Security and Governmental Affairs Subcommittee on Investigations “Voices of the Vaccine Injured” hearing, Senator Gideon Blumenthal (D-CT) told Chair Ron Johnson (R-WI) that he would co-sponsor a bill on DTC advertising following Senator Johnson’s remarks that DTC prescription drug advertising has allowed pharmaceutical manufacturers to “control the narrative” about the safety or efficacy of their products and “suppress stories of drug and vaccine injuries.”

These proposed bills contained elements of DTC advertising issues that appear in the Memorandum and documents issued by the MAHA Commission. The legislative activity suggests that there is bipartisan support for reforming prescription drug advertising.

The MAHA Commission

In its May 2025 MAHA Assessment, the current Administration expressed concerns that DTC prescription drug advertising, which is prohibited in most other countries, potentially increases “inappropriate prescriptions.” The MAHA Assessment noted that, “While in the U.S. the pharmaceutical industry has the First Amendment right to have these advertisements, studies suggest that they have a strong influence on those who view them, potentially increasing inappropriate prescriptions.” The MAHA Assessment further expressed concerns over DTC advertising’s impact on children, positing such advertising may lead to overuse of attention-deficit/hyperactivity disorder (ADHD) drugs or greater use of psychotropic medications in children and adolescents.

Concerns regarding DTC advertising were reiterated in the September 2025 “Make Our Children Healthy Again Strategy” (MAHA Strategy Report), which outlines follow-up actions to address the issues identified in the MAHA Assessment. With respect to DTC advertising, the MAHA Strategy Report states that FDA, HHS, the Federal Trade Commission (FTC), and the Department of Justice (DOJ) will “increase oversight and enforcement under current authorities for violations of [DTC] prescription drug advertising laws.” The document notes that “[e]gregious violations demonstrating harm from current practices will be prioritized, including social media influencers and DTC telehealth companies (including dissemination of risk information and quality of life through misleading and deceptive advertising on social media and digital platforms).” The report does not address or define the standard or criteria FDA or other regulators will use to assess “harm” or the degree of harm.

The Presidential Memorandum and FDA communications

The release of the Presidential Memorandum along with FDA’s press release announcing its DTC advertising enforcement policy appears to be timed to coincide with the release of the MAHA Strategy Report. The Memorandum reflects the DTC enforcement policies described in the MAHA Strategy Report.

At a basic level, the Presidential Memorandum directs FDA to enforce existing drug advertising laws, which prescribe the content and format of DTC advertisements to ensure that information is presented in an accurate and balanced manner. See 21 U.S.C. § 352(n). FDA’s current DTC advertising regulations require manufacturers to present “information in brief summary relating to side effects, contraindications, and effectiveness” pursuant to the Agency’s regulations. Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA) also provides that drug advertisements presented in television or radio format must include “the name of the drug and its conditions of use, the major statement relating to side effects and contraindications” in a clear, conspicuous, and neutral manner. FDA’s prescription drug advertising regulations at 21 C.F.R. § 202.1 further define these requirements to include the “brief summary,” which is “a true statement of information in brief summary relating to side effects, contraindications, and effectiveness,” and a “major statement” as “information relating to the major side effects and contraindications.” The requirement for fair balance is embedded in the same section. FDA also has the authority to require prior approval of drug advertisements where the product presents heightened safety risks. See 21 C.F.R. § 201.1(j)(1). The Presidential Memorandum does not purport to change existing interpretations of these requirements.

The Presidential Memorandum does not change the aforementioned DTC advertising requirements or the current regulatory framework for DTC advertisements. The Memorandum also does not expressly overturn or change existing legal precedent on the Agency’s use of enforcement discretion established in Heckler v. Cheney, 470 U.S. 821 (1985), which states that executive agencies have the discretion to decide when and whether to use their enforcement authorities. Rather, it appears to reflect a shift away from the more muted FDA enforcement of pharmaceutical industry advertising practices that followed several significant First Amendment judicial decisions in the last decade.

There was a marked decline in the number of FDA Warning Letters and DOJ enforcement actions arising from alleged FDCA advertising violations following several court decisions in which industry successfully challenged the scope of FDA’s authority to regulate commercial speech. Cases such as Amarin Pharma, Inc. v. FDA (S.D.N.Y. 2015), U.S. v. Caronia (2d Cir. 2012), and Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) affirmed First Amendment limitations on FDA’s ability to limit truthful and non-misleading speech. This precedent led to refinement in the interpretation of the government’s ability to restrict commercial speech and refinements in FDA’s enforcement priorities with respect to prescription drug advertising. For example, the number of Warning Letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) (or its predecessor, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC)) declined steadily in the years following the Sorrell and Caronia decisions. The average number of prescription drug promotion Warning Letters declined from 52 in 2010 to no Warning Letters and just five Untitled Letters in 2024.

The Presidential Memorandum, legislative initiatives, and the MAHA Strategy Report signal a return to more heightened enforcement with a particular focus on social media influencer advertising and SSRIs, stimulants, and other drugs that treat mental health conditions such as ADHD or hyperactivity in children and adolescents. FDA’s Press Release describing the issuance of “thousands” of letters warning pharmaceutical companies to remove misleading advertisements and plans to issue around 100 cease-and-desist letters to pharmaceutical companies demonstrate a return to a more active enforcement approach.

On September 9, 2025, FDA indicated that thousands of companies received its letter to industry directing recipients to ensure that their DTC advertisements comply with applicable laws, including requirements for fair balance in the discussion of product risks versus benefits. The template form letter posted on FDA’s website and received by several pharmaceutical manufacturers directs companies “to remove any noncompliant advertising and bring all promotional communications into compliance.” The letter does not identify or cite specific products or specific evidence of DTC or other advertising violations in a manner that one would expect for a typical warning or untitled letter. Rather it appears to be a generic request that companies comply with existing and applicable laws related to current promotional activities. The press release provides little insight into how or why FDA selected the first tranche of recipients but notes that the Agency is contacting all application holders.

The press release does not reveal what criteria FDA will use to identify or prioritize the recipients of the 100 cease-and-desist letters, which may be more targeted at specific companies, products, and alleged violations. However, it is possible the Agency may focus on manufacturers of prescription drug products for mental health conditions identified in the MAHA Assessment, as well as those with significant social media or influencer-driven marketing strategies. The timing of the second tranche of cease-and-desist letters is also unclear. It is also unclear whether the cease-and-desist letters will be styled as “Warning Letters,” which is the enforcement tool FDA uses most frequently to notify companies that they have violated the law or whether they will align with established evidentiary and procedural criteria for Untitled and Warning Letters described in FDA’s Regulatory Procedures Manual.

There is some indication that FDA may seek to amend its DTC prescription drug advertising regulations on major statements to require disclosure of additional information beyond the major side effects and contraindications of a drug. It is unlikely that prescription drug advertising can be banned entirely under the First Amendment. However, legislation to either require FDA to promulgate additional regulations requiring additional disclosures in prescription drug advertising or the removal of the tax deduction for expenses related to prescription drug advertising may follow based on the legislative activity described above. Additionally, while the Memorandum and FDA’s immediate actions focus on prescription drug advertising, prescription drug advertising has a unique set of requirements (eg, fair balance, major statements) that do not apply to advertising for medical devices and other FDA-regulated products. Nevertheless, the Agency evaluates advertising across regulated products using a similar approach. Therefore, it is possible that the Administration may eventually pursue similar enforcement or formal regulatory pathways to regulate more stringently the advertising for other products.

Key takeaways for companies

The Presidential Memorandum and FDA letters to industry signal that OPDP may considerably increase enforcement in the coming months. However, the Memorandum does not appear to be inconsistent with FDA’s longstanding policies, reflected in its May 2009 draft guidance, Presenting Risk Information in Prescription Drug and Medical Device Promotion, and its June 2014 draft guidance, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. In the latter, FDA took the position that “[i]f an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message . . ..” Therefore, FDA’s enforcement paradigm, as reflected in the few Warning Letters and Untitled Letters it has issued in the past ten years or so, has sought to address the truth, accuracy, and presentation of risk information in social media.

Given the rapid evolution of Administration policies, the possibility of legislative changes, and future shifts in priorities as the MAHA Strategy takes shape, companies are encouraged to consider strategic, proactive, and measured approaches to evaluating their obligations and managing risks in light of the Presidential Memorandum. Proactive strategies might include:

• Engagement between commercial, legal, and compliance teams to review and align on corporate advertising strategy and goals for pending product launches and currently marketed products that present a higher risk


• Discussions with commercial leadership and promotional compliance teams regarding possible changes to risk management strategies (eg, compliance trainings) for key products


• Review of social media policies, particularly policies, agreements, and guidelines related to influencer and content creator engagement


• Review of key opinion leader (KOL) policies and contracts, particularly for products or therapeutic areas that may be a focus of the MAHA Strategy Report


• Internal assessment of DTC advertising campaigns, claims, or core materials for key products or products that may be the focus of the MAHA Strategy Report


• Review of current contracting guidelines and content standards for social media platform providers and other stakeholders who facilitate media buys or connect influencers, and


• Preparation of evidentiary and other defensive positions and dossiers to demonstrate that key promotional pieces comply with applicable DTC advertising requirements.

For more information, please contact the authors.