On Sept. 9, 2025, the U.S. Department of Health and Human Services and the Food and Drug Administration jointly announced a crackdown on deceptive direct-to-consumer (DTC) pharmaceutical advertising, including promotion through social media influencers. The announcement follows on the heels of a presidential memorandum and report by the Trump administration’s Make American Healthy Again (MAHA) Commission, which directed the FDA, HHS, Federal Trade Commission and Department of Justice to increase oversight of DTC pharmaceutical advertising, particularly associated with risk information on digital platforms.
The resulting rule changes and increased scrutiny from regulators may have significant implications for pharmaceutical manufacturers.
Historical Proliferation of DTC Ads and Social Media
From the start of DTC advertising in the 1980s until 1997, the FDA required pharmaceutical advertisements to include a “brief summary” of side effects, contraindications and effectiveness. As a practical matter, pharmaceutical companies rarely could cover this information within the time constraints of broadcast media, and the FDA in 1983 called for a voluntary moratorium on DTC ads because of concerns about the ability to appropriately communicate risk information to patients through short ads. Broadcast advertising accordingly was limited.
The FDA rescinded the moratorium in late 1985, and by the early 1990s allocated additional resources to the regulation of drug advertising. This increased oversight came despite suggestions from legal scholars that the FDA didn’t have authority to regulate DTC advertising and that its authority was limited to communications by firms to physicians.
The FDA Modernization Act of 1997 permitted broadcast advertisements to present a brief summary or, alternatively, make “adequate provision … for dissemination of the approved or permitted package labeling in connection with the broadcast presentation.” The FDA issued draft guidance, finalized in 1999, explaining that drug makers could meet this “adequate provision” standard by directing consumers to external sources, such as websites, toll-free numbers and publications in widely available magazines or periodicals for full product safety information.
This change was noted widely in the press. The Washington Post reported in August 1997 that then-FDA Commissioner Michael J. Friedman viewed the change as “part of a broader FDA effort to provide consumers with better, more understandable drug information, [which] “‘can help promote greater consumer awareness about prescription drugs.’” But consumer advocates were wary of the potential impact: Sidney Wolfe, then the head of Public Citizen’s Health Research Group, called it “a setup for misleading people.”
Prescription drug ads on television and radio skyrocketed. It did not take long for major pharmaceutical companies to use the “adequate provision” rule and deploy the power of television to propel new brands to blockbuster status. The first Viagra DTC ads (starring Senator Robert Dole) began airing in 1998 shortly after the drug’s approval. Prescription drug DTC advertising increased from $1.3 billion in 1997 to $6 billion in 2016, with the number of advertising occurrences increasing from 79,000 to 4.6 million.
The rise of social media triggered another seismic shift in prescription drug promotion. By some reports, the use of social media for pharmaceutical marketing has grown 45% year-over-year, with nearly 50% of pharmaceutical digital advertising budgets allocated to social media channels by 2025.
Recent Developments
Against this backdrop, President Donald Trump on Sept. 9, 2025, issued a memorandum directing HHS to “take appropriate action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements.” The memorandum further directed the commissioner of food and drugs to “take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions, and otherwise ensure truthful and non-misleading information in direct-to-consumer prescription drug advertisements.”
The MAHA Commission on the same day released a report explaining that the FDA, HHS, FTC and DOJ “will increase oversight and enforcement under current authorities for violations of direct-to-consumer (DTC) prescription drug advertising laws.” The report highlighted that “[e]gregious violations demonstrating harm from current practices will be prioritized, including by social media influencers … (including dissemination of risk information and quality of life through misleading and deceptive advertising on social media and digital platforms).”
Building on these admonitions, the FDA announced that it 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.” The FDA noted that it was “increasingly lax and reactive in its enforcement approach” for decades “[d]espite widespread violations.” In support of its claims, the FDA cited a 2024 literature review by Canadian and Auklander nursing faculty, which found that 100% of social media posts for top pharmaceutical manufacturers and products globally included drug benefits, while only 33% of posts mentioned possible harms. The authors of that study acknowledged that there is “a paucity of research examining the public health impacts of these promotional activities.” The FDA also voiced concern that “88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to FDA ‘fair balance’ guidelines.” This assertion is based on a 2012 study by Swiss dermatologists of eczema-related YouTube videos published during a one-month period in September 2009.
In the announcement, the FDA declared that it “will no longer tolerate such deceptive practices.” While the FDA has not formally withdrawn its 1999 DTC “adequate provision” guidance, the agency noted that it would “aggressively deploy” its available enforcement tools, with “heightened scrutiny” of fair balance and disclosures in social media promotions. The FDA cautioned that it already is implementing AI and other tech tools to “proactively surveil and review drug ads”and reported that the FDA was issuing thousands of letters “warning pharmaceutical companies to remove misleading ads” and approximately 100 cease-and-desist letters “to companies with deceptive ads.” Unlike the Untitled Letters and Warning Letters historically issued on case-specific bases by the FDA, the notice letter attached to the FDA’s Sept. 9 press release is generic, without facts specific to any of the intended recipients. HHS described the change as a “major reform of pharmaceutical advertisements” that would mark a “return to the pre-loophole status quo.”
The Office of Prescription Drug Promotion (OPDP) — the office within the FDA’s Center for Drug Evaluation and Research responsible for reviewing prescription drug advertisements for compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) —rarely took enforcement action in recent years. The OPDP issued four Untitled Letters and one Warning Letter in 2023, and five Untitled Letters and no Warning Letters in 2024. There is no public record of the OPDP issuing “cease-and-desist” letters in recent years. Recent workforce reductions in the OPDP, including the departure of several leadership officials, may have facilitated the FDA’s change of position.
For its part, Pharmaceutical Research and Manufacturers of America (PhRMA) — the preeminent American trade group representing pharmaceutical companies — responded to the FDA’s announcement by reiterating its long-standing position that “DTC advertising provides patients with important fact-based, useful and accessible information about potential treatment options. PhRMA’s member companies are committed to responsible, accurate advertising that helps Americans make informed decisions about their health care in consultation with their doctor.” PhRMA in 2018 adopted — and continues to support — “Direct To Consumer Advertising Principles” that acknowledge pharmaceutical companies’ obligations to ensure that DTC communications comply with all FDA regulations and seek to ensure that patients “fully understand the known risks regarding these medicines.”
Implications for Pharmaceutical Manufacturers
The shift in enforcement posture and forthcoming rule changes may have significant implications for pharmaceutical manufacturers. Drug makers could be at increased risk for consumer claims, shareholder suits and governmental investigations.
Manufacturers should proactively review their DTC and other digital campaigns, including social media influencer partnerships, to assess compliance with fair balance requirements and anticipated rule changes. They should reconsider legacy campaigns relying on the “adequate provision” of safety information. Manufacturers should pay attention to the fair balance requirements set forth in 21 C.F.R. § 202.1(6), which lists 20 factors that can render an advertisement to be false, misleading or lacking in fair balance, and cause a drug to be “misbranded” in violation of the FDCA. Manufacturers should also track the FDA’s interpretation of these fair balance requirements, whether in FDA guidance documents, Warning Letters, Untitled Letters or other public statements, going forward.
More broadly, manufacturers should ensure to update their policies and procedures governing the review of promotional materials and use of social media to account for the forthcoming rule changes and ensure that safety information is presented in full.
Manufacturers should also consider the possibility of imminent DOJ enforcement action. While the FDA routinely issues correspondence such as Warning Letters and Untitled Letters in its attempts to obtain voluntary compliance from the industry, the issuance of advisory letters on such a massive scale, along with approximately 100 cease-and-desist letters, suggests that the FDA is positioning itself for the long game. The DOJ is authorized to pursue civil litigation — including injunctive relief — against companies that violate FDCA requirements. To minimize potential defenses in such matters, the DOJ historically preferred a fact pattern in which the putative defendant was put on notice of alleged FDCA violations before a complaint is filed. Here, the synchronized barrage of cease-and-desist letters suggests that the FDA and the DOJ may already be preparing for civil enforcement action in certain cases. Manufacturers that receive cease-and-desist letters should anticipate the possibility of DOJ enforcement action and work with legal counsel to prepare.
Pharmaceutical manufacturers that received notice letters or cease-and-desist letters from the FDA should engage legal counsel to advise on available defenses and develop an appropriate strategy for response.
The McGuireWoods life sciences team stands ready to assist companies with assessing and addressing emerging issues in this rapidly developing legal and regulatory landscape governing DTC advertising.