The White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA) and its rules governing direct-to-consumer (DTC) prescription drug advertising. In response, FDA issued an announcement regarding planned rulemaking and more immediate enforcement actions and strategies.
This initiative heralds a new era of regulatory scrutiny of drug advertising practices, and although the full scope and long-term impact of this initiative remain uncertain, the implications for the pharmaceutical industry are likely significant. In light of signaled increases in enforcement, companies should reassess existing promotional and advertising strategies, reinforce and strengthen internal review processes, and prepare for a more aggressive enforcement landscape while simultaneously staying abreast of planned regulatory changes.
Regulatory Background: Fair Balance and Adequate Provision
DTC advertising is governed by the FFDCA and implementing regulations under 21 CFR Part 202. A central requirement is the “fair balance” standard, which applies across media formats and mandates that promotional materials present risk information with comparable prominence to benefit claims. Historically, broadcast ads have relied on FDA’s “adequate provision” regulatory standard, which permits broadcast ads to provide a “major statement” of risks so long as they also make an “adequate provision” directing consumers to other sources (e.g., websites or toll-free numbers) for the full prescribing information.
However, according to a recently released HHS fact sheet, the “adequate provision” standard—which “denies patients vital safety information required for them to make an informed decision—has had a clear negative impact on public health.” Further, FDA has now also signaled its intent to eliminate the “adequate provision” standard through planned rulemaking that would require risk disclosures to be integrated more directly into advertising itself. The timing and precise scope of any such rulemaking remain unclear.
FDA Signals a Crackdown
While enforcement actions from FDA’s Office of Prescription Drug Promotion (OPDP)—the office tasked with reviewing promotional materials and issuing enforcement letters where content is false, misleading, or otherwise fails to comply with FFDCA requirements—have ebbed and flowed over the years. FDA’s announcement signals its intent to increase enforcement significantly, and that this shift is not likely to wait for the planned rulemaking.
Notably, FDA’s announcement was also coupled with the issuance of approximately 100 cease-and-desist notices and separate form letters sent to pharmaceutical companies generally warning them to remove “any noncompliant advertising” and to “bring all promotional communications into compliance.”
Current staffing and resource constraints (including within OPDP itself) may impact the degree to which existing FDA resources can be diverted to these efforts. On the other hand, FDA has also indicated that it plans to employ artificial intelligence and other digital tools to enhance its surveillance arsenal, which may to some degree serve to counterbalance recent staffing losses.
Companies should also keep in mind that the FFDCA is a criminal statute. Promotional claims and representations that are false, misleading, or fail to fairly balance benefits with risks can lead not only to FDA-issued enforcement letters and notices, but also to criminal misbranding charges. In such cases, the US Department of Justice (DOJ) may pursue prosecutions against both companies and individuals. Historically, criminal violations of the FFDCA have been handled by the Consumer Protection Branch in DOJ’s Civil Division, which is currently being collapsed into the Criminal Division.
It is also worth considering that enforcement may not be limited to FDA alone; we anticipate that state attorneys general (as we have outlined previously), particularly those with active consumer protection divisions, may also pursue deceptive advertising practices that implicate both federal and state law. In addition, and as noted in our February 24, 2025 and August 4, 2025 LawFlashes, the US administration has demonstrated a willingness to pursue novel legal theories under the federal civil False Claims Act (FCA) and to actively encourage FCA relators to file qui tam lawsuits.
While FDA’s announcement does not explicitly reference the FCA or private whistleblower complaints, its characterization of misleading pharmaceutical ads as a “pipeline of deception” that conceals critical safety risks and promotes medically unnecessary and clinically inappropriate drug use may nonetheless invite them. Although companies would likely have strong defenses against an FCA suit premised on misbranding under these circumstances, the potential impact of such litigation could still be significant.
Ultimate Scope
While social media advertising has previously been an area of FDA focus, this latest action signals that FDA may be zeroing in even further on social media posts, and especially influencer content. Both the FDA press release and the letter to companies drew specific attention to the use of social media in drug promotion and advertising. It is also possible that other consumer- and patient-directed promotion and advertising that have traditionally avoided equally strict oversight may be swept under the umbrella (e.g., medical and educational communications and content).
Beyond compliance, FDA’s initiative raises broader questions about the balance between consumer protection and First Amendment protections for commercial speech. If FDA moves to aggressively police truthful advertising, courts may be asked to evaluate whether such restrictions are constitutionally permissible in addition to addressing other potential challenges under the Administrative Procedure Act. Whether and how these announcements translate into long-term regulatory changes or remain a temporary policy shift will depend on the outcome of forthcoming rulemaking, FDA’s enforcement posture in the coming years, and the results of challenges to either one.
Additionally, companies of other FDA-regulated products, such as medical devices, should take note, as policy shifts in the drug space can often creep into other FDA-regulated product areas. Despite differences in the applicable legal and regulatory scheme, FDA’s efforts under this initiative will likely signal broader policy and enforcement trends applicable to the regulation of medical products broadly, including medical device advertising and promotion. Medical device companies, therefore, should closely monitor FDA’s next steps to ensure they stay abreast of current advertising and promotion enforcement priorities to ensure they are able to anticipate and prepare for a potential expansion of this initiative.
Implications for Industry Stakeholders
FDA’s new enforcement posture presents both compliance challenges and strategic risks for pharmaceutical companies, especially those with active or planned DTC campaigns across traditional and digital platforms. These actions represent a significant shift in DTC drug advertising regulation that portends a material change in compliance risk. Pharmaceutical companies should therefore consider the following key implications to proactively mitigate risk:
- Think Broadly: While FDA’s recent actions focus on DTC advertising, it is possible that we will see broader enforcement across both promotion and advertising. Accordingly, companies should remain vigilant to ensure that all content is compliant with FDA’s promotional expectations.
- Reevaluate Promotional Strategies: Companies should immediately review all existing and planned advertising and promotional campaigns across all platforms to assess compliance with both current FFDCA rules and the likely contours of future regulation, paying particular attention to campaigns that rely on FDA’s “adequate provision” standard. While companies frequently rely on FDA precedent to understand promotional and advertising guardrails, the FDA crackdown suggests that recent precedent may not provide the benchmark that it once did. Companies should pay special attention to FDA’s enforcement posture as it may evolve to understand particular areas of risk.
- Strengthen Internal Review Processes: Medical-legal-regulatory committees should be trained and resourced to evaluate promotional content under heightened scrutiny. Review protocols should be updated to reflect FDA’s broader interpretation of DTC advertising and its focus on integrated risk disclosures. Similarly, employees and executives should receive a refresher training on FDA’s promotion and advertising requirements, including training with respect to their own social media use regarding company products.
- Audit Influencer and Third-Party Agreements: Companies should revisit contracts with influencers, brand ambassadors, and third-party content creators to ensure that sponsorships are clearly disclosed, risk information is prominently included, and content otherwise meets FDA promotional requirements.
- Prepare for Enforcement: Companies should develop response strategies in case of FDA enforcement action. This includes conducting internal audits of promotional materials, documenting good-faith compliance efforts, and establishing protocols for responding to warning letters, cease-and-desist notices, criminal grand jury and HIPAA subpoenas, and FCA civil investigative demands.
- Monitor Rulemaking and Guidance: FDA’s anticipated rulemaking to eliminate the “adequate provision” standard and expand oversight of digital advertising will require close monitoring. Companies should engage in the regulatory process, submit comments where appropriate, and prepare to adapt to new requirements as they come into effect.
How We Can Help
Our team is closely monitoring developments and can assist with compliance reviews of advertising and promotional content and processes, provide a refresher training for marketing and legal teams given the changing risk profile in the space, provide guidance on developing response strategies in the event an FDA letter is received and advise on how best to position a company for possible DOJ enforcement actions.