In a major shift, FDA unveils ‘crackdown’ on DTC drug advertising, with a plan to make drugs ads infeasible

FDA’s newly announced “crackdown on deceptive drug advertising” argues that drug companies and influencers have been misleading patients, with regulators having been previously asleep at the wheel. The agency’s new approach will leverage tougher enforcement of existing authorities and a massive change: The withdrawal of a major, foundational regulation which allows drug advertisements to be relatively brief. If the FDA can withdraw this rule, it could mark the de-facto end of drug advertising on television and radio.

What’s new

• According to the FDA’s new announcement, the agency is “concerned patients are not seeing a fair balance of information about drug products. This concern is magnified when serious risks are not clearly presented, or the information is too difficult for seniors to read or hear,” it wrote.
• At a high level, the FDA and HHS’s new stance appears to be that many modern drug advertisements are deceptive by virtue of omission. “Pharmaceutical ads hooked this country on prescription drugs,” said HHS Secretary ROBERT F. KENNEDY JR. in a statement. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
• As part of FDA’s new crackdown, it is initiating a series of major efforts aimed at several different channels of advertising. Ultimately, these actions will – if fully enacted – make drug advertising on television and radio extremely difficult for all but a few drug products.
• First, the FDA said it would be initiating rulemaking actions related to direct-to-consumer advertising. Specifically, the agency would initiate rulemaking to remove a critical regulation, known as the “adequate provision” requirement, which it argues has “enabled pharmaceutical companies to withhold vital safety information in advertisements.” The adequate provision requirement allows companies to provide risk information about a drug using an abbreviated version of its list of side effects. This has the effect of allowing drug advertisements to be modest in length, as the FDA had said that if it required TV ads to list the same side effects as they list in print advertising, the ads “would take many minutes to read or scroll down a TV screen.” Under current law and regulations, broadcast advertisements are permitted “to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug’s risks.” In a statement, HHS argues that this is a “loophole,” and that prior to 1997, DTC drug ads “were required to report full contraindications, boxed warnings, and common precautions in advertisement.” And, it concedes, at that time “pharmaceutical broadcast ads were rare because of the time it would take to read safety information.”
• Second, it said it had sent letters to “every single sponsor of an approved drug or biologic” directing them to “remove any noncompliant advertising and bring all promotional communications into compliance.” The letters largely mirror FDA’s public announcement in terms of content, though it adds that they were sent to “all application holders.” Notably, they do not state that FDA intends to revoke the adequate provision requirement in the future.
• Third, it indicated that it plans to “aggressively deploy its available enforcement tools,” including untitled letters and warning letters. This follows a period of time in which the FDA’s Office of Prescription Drug Promotion has sent relatively few of both types of letters, which the agency said in a statement had reflected an “increasingly lax and reactive” enforcement approach. In a statement on social media, FDA Commissioner Makary said FDA was “sending approximately 100 enforcement action letters today,” which FDA explained were “cease-and-desist” letters. However, the agency didn’t provide additional details on those letters, including which companies received them or what companies were warned about. The letters do not appear to have been posted on the agency’s website as of midnight on Tuesday, Sept. 9, when this analysis was being written. However, an HHS statement explained that FDA “will take a more expansive reading of its authorities in contrast to the overly cautious approach taken by previous administrations.” Further, if the FDA does not see sufficient action by industry, it says it will “continue enforcement activity and will return to the 1990s paradigm of issuing hundreds of enforcement letters each year.”
• Fourth it will be increasingly focused on “digital and social media channels,” with an emphasis on “undisclosed paid influencer promotions” that it says made it “increasingly difficult for patients to distinguish between evidence-based information and promotional material.” The FDA cited a research review which found that 88% of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines. However, that isn’t what the study says. It states that 88% of advertisements were posted “by individuals, such as healthcare providers and organizations who did not necessarily adhere to FDA ‘fair balance’ guidelines.” (Emphasis added) Regardless of the study, HHS states that FDA will expand its oversight “to encompass all social media promotional activities,” including: (1) Influencer partnerships and sponsored content across all platforms; (2) Algorithm-driven targeted advertising and “dark ads”; (3) AI-generated health content and chatbot interactions; (4) Platform-specific promotional strategies designed to evade detection; and (5) Emerging digital technologies and promotional methods.
• Fifth, FDA indicated that it would be using new tools as part of its monitoring and enforcement efforts. “The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads,” it wrote. However, no other information on this capability was provided in its statement.
• The White House is also playing a role in this action. A new Presidential Memorandum signed on Sept. 9 by President DONALD TRUMP argues that, over time, “FDA’s requirements have permitted drug companies to include less information, particularly in broadcast advertising, and drug manufacturer advertising has skyrocketed in recent decades.” Accordingly, HHS is directed 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, to the extent permitted by applicable law.” The FDA is directed to enforce these provisions, including that drug advertising be truthful and non-misleading.

Analysis

• This is a massive, sea-change moment for the pharmaceutical and biopharmaceutical industry. Removal of the “adequate provision” regulation would effectively overturn a nearly 30-year-old bedrock of drug advertising regulation and powerfully disrupt the way that drugs are marketed and sold in the U.S. For most drug and biologics companies, the removal of this regulation will mark a “before and after moment,” with “before” marking a period of time in which it was feasible to market products relatively easily to consumers, and the “after” marking a period in which it is prohibitively difficult to do so.
• How would FDA actually overturn this requirement? The rulemaking process tends to be relatively involved, but generally starts with a proposed notice of rulemaking, a comment period and then the issuance of a final rule. Our assumption is that FDA will soon (and perhaps today or tomorrow) publish a proposed rule to start this process, which will offer us the first look at the exact mechanisms by which it would accomplish its goals. At its simplest form, FDA could simply delete a single reference – 21 CFR 202(1)(i)(B) – in the Code of Federal Regulations to accomplish its goal. That reference reads: “Advertisements broadcast through media such as radio, television, or telephone communications systems must: (B) Contain a brief summary of all necessary information related to side effects and contraindications, unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.” As far as regulatory changes go, this is relatively straightforward and likely wouldn’t require significant effort. As a result, we wouldn’t expect that this regulation would take an especially long time to enact in final form – perhaps early 2026, unless litigation slows down the FDA and HHS.
• What about for companies who still hope to engage in advertising on TV, radio or the internet. What do they need to know? Even before the adequate provision regulatory changes go into effect, it’s clear that the status quo seems likely to rapidly change. FDA’s enforcement of the “fair balance” requirement has almost always involved interpretation, which makes it particularly susceptible to changes in enforcement doctrine. The FDA’s regulations offer a wide range of potential scenarios that could cause an advertisement to be considered false, lacking in fair balance or otherwise misleading, offering the agency considerable latitude for the purposes of enforcement. 21 CFR 202.1(6) offers 20 different standards that companies must comply with, which include not overstating a drug’s benefits, creating the impression a drug is safer or more effective than its indication for use, providing misleading information about data used to support the drug, or taking information out of context.
• Which leads to perhaps the most important question of all for industry: Just how much additional risk information will FDA require as part of this new crackdown? Without formal guidance from the FDA, we suspect industry won’t know what the FDA wants until it has a chance to read the 100+ enforcement letters to other companies (or, for the unlucky companies, to themselves). But based on FDA’s statements so far, in combination with President Trump’s memorandum, FDA appears to want more – more risks listed, more compliance, more disclosures and more hesitation before advertising. FDA’s letter to all drug application holders demands that companies “remove any and all DTC prescription drug advertising that violates the law,” but fails to explain which (if any) types of regulations it believes might be violative of the Federal Food, Drug and Cosmetic Act.
• It also seems likely that other types of advertising and promotion, such as to physicians, will ultimately be affected by FDA’s broader shift in approach. Many of the untitled and warning letters sent by the FDA to companies relate to advertising and promotions in physician-focused media, such as journals, flyers, handouts and conference advertising. Of course, part of the reason it is so often picked apart is that when you have an expert audience, they tend to scrutinize every claim a company makes and report any claims they feel are inaccurate to the FDA using its BadAd program. But if the agency is planning to more carefully scrutinize DTC advertisements, we suspect other types of advertising likely isn’t far behind.
• While FDA is promising additional enforcement, companies should expect legal action in addition to regulatory enforcement. As part of the Make America Healthy Again (MAHA) Strategy report, also released on Sept. 9, HHS wrote that the FDA, Federal Trade Commission and the Department of Justice “will increase oversight and enforcement under current authorities for violations of direct-to-consumer (DTC) prescription drug advertising laws. Egregious violations demonstrating harm from current practices will be prioritized, including by 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).” As with other actions by the Trump administration, we expect these initial enforcement actions to be primarily targeted at major companies for the purposes of warning other companies.
• Some of FDA’s broader crackdown on drug advertising could feature stricter enforcement of a relatively recent regulation, the FDA’s “clear, conspicuous and neutral” drug advertising rule. That rule, which was finalized in November 2023 and came into effect in November 2024, requires drug companies to only air advertisements on television and the radio without distracting elements. The rule described five standards for determining whether information on major side effects or contraindications, which are known as the “major statement” in the advertisement, are clear, conspicuous and neutral under the law. Factors include whether the major statement is presented in “consumer-friendly language,” is adequately paced, is presented in both audio and visual (text) format simultaneously, that the text is easily legible, and the major statement is not obscured by audio or visual elements. The rule was accompanied by a Q&A guidance document further explaining those standards. To date, FDA hasn’t mentioned the CCN rule in any warning letters or untitled letters, but we suspect that FDA could use it in a bid to target advertisements it finds obnoxious.
• Something to watch here relates to the limits of FDA’s advertising authority. Of all the authorities FDA regularly makes use of, its advertising authority has historically been among the most challenged and weakest due to some of its inherent conflicts with the first amendment right to free speech. In general: While the U.S. government can restrict speech in certain cases, there are limits on the extent to which such restrictions are permissible. These restrictions must generally comply with a legal framework known as The Central Hudson test, after the Central Hudson Gas & Electric v. Public Services Commission case it is named after. Among the most important cases relating to FDA’s advertising oversight authority is US v. Caronia (2012), which affirmed the rights of persons and companies to make truthful and non-misleading claims about their drugs, even when off-label promotions were concerned. Any major restrictions by the FDA of truthful and non-misleading speech, including advertisements by companies, could trigger legal action by the pharmaceutical industry challenging the regulation.
• FDA’s statement doesn’t make this seem like it’s likely to be a tempered, cautious attempt at enforcement. Kennedy’s statement that he intends to “shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising” seems to indicate that the goal is to make drug advertising an onerous exercise, and one that some companies may choose to rethink.
• Could some companies instead decide to shift investments to “disease awareness” advertisements instead? FDA’s regulations around DTC advertising are clear: If you promote a drug with claims about its effectiveness, you need to also provide equal weight to discussing its risks. But if a company decides to advertise about the availability of new and effective treatment options for a disease without naming that drug, then the FDA doesn’t have any regulatory authority over that product (it would fall under the Federal Trade Commission’s regulations). If FDA does finalize a regulation eliminating the adequate provision regulation, this option could become enticing to some companies that hope to reduce their regulatory or legal exposure – and spending – while still capturing some of the benefits of advertising directly to consumers. Companies might also choose to make greater use of “reminder” ads, which list the drug’s name but not the drug’s use. However, that advertising type isn’t appropriate for drugs with boxed warnings.
• The FDA’s proposal to use AI to monitor and enforce DTC advertising could be a game-changer – if the technology works as intended. Historically, the FDA’s regulation of DTC advertising has faced some practical, capacity-related challenges. First, the agency needs to be aware of the advertisement to be able to regulate it. For drug advertisements on TV and radio, this is submitted to the FDA using Form FDA 2253. Next, the FDA needs the capacity to review these advertisements. In FY 2024, the FDA reports that it received 70,960 Form 2253s, inclusive of 149,516 different advertisements (some submissions contain multiple sets of advertisements). Even if FDA has the capacity to review the advertisements, it needs the ability to deeply understand what it’s looking at. Even advertisements which blatantly violate federal regulations often don’t violate them in obvious ways. Rather, they might overstate the impact of a study, which is only evident if you have a deep understanding of the drug’s label and the evidence it relies on. And then the FDA needs sufficient staff to generate enforcement actions. At nearly all steps, capacity is a significant bottleneck. If the FDA is able to leverage artificial intelligence to automatically compare drugs advertisements with approved labels and identify potentially violative ads, or to monitor social media channels to identify ads which appear to violate fair balance rules, then the agency could resolve some of those bottlenecks. However, we are not aware of any existing technologies in effect at the FDA capable of handling this work at scale, and it seems likely that this goal is currently more aspirational than operational.
• Depending on how FDA implements this new approach, it could also have significant political implications. Many broadcast media companies, including ones providing conservative-leaning coverage generally favorable to President Trump like Fox News and Sinclair Broadcasting, generate significant revenues from DTC advertising. Because of the requirement to provide fair balance to the benefits and risks of a drug, drug advertisements are long and are therefore expensive airtime. They also tend to run for long periods of time, unlike a retailer which might only be running a seasonal promotion. If companies feel pressure to run fewer advertisements, or instead choose to switch to shorter and less-costly “disease awareness”-style advertisements, then the revenues of broadcast media companies could take a hit. And diminished revenues could put income pressures on some broadcaster personalities, including some vocal proponents of the Trump administration. (AgencyIQ does not run any advertisements, though our parent company, POLITICO, and its parent company, Axel Springer, do.)
• Of course, one irony in all of this is that FDA has recently laid off a significant portion of (or promoted retirements within) its Office of Prescription Drug Promotion, the office most principally tasked with regulating DTC advertising. Earlier this year, its two leaders – CATHERINE GREY and MARK ASKINE – retired, and a large portion of its policy office was subject to the reduction in force. It’s not clear who is running the office at the moment, though TWYLA MOSEY is listed as the acting director in at least one conference webpage we saw (she is otherwise division director of OPDP’s Division of Advertising and Promotion Review II). ANDREW HAFER is currently the division director of DAPR I. At present, the HHS Directory lists 51 staff as being affiliated with OPDP. However, in our experience that resource is often out of date and doesn’t reflect staff on administrative leave.
• The FDA’s approach doesn’t call for new authority from Congress, but we suspect Congress might be interested in weighing in regardless. Legislators have already introduced several bills intended to more stringently enforce drug advertising during the most recent session of Congress, including the Protecting Patients from Deceptive Drugs Ads Act (S. 652), the Responsibility in Drug Advertising Act (S. 483), the Drug-price Transparency for Consumers (DTC) Act of 2025 (S. 229), and the End Prescription Drug Ads Now Act (S. 2068). While all these bills differ significantly, they speak to significant interest by legislators to reform FDA drug advertising.
• We suspect that the long-term impact of this policy could also result in updates to some of the FDA’s key AdPromo guidance documents. Two of which immediately come to mind are its guidance documents on promoting drug products on social media: One on the use of social media platforms with character space limitations, and the other on fulfilling regulatory requirements for postmarketing submissions of interactive promotional media. Both documents are about a decade old, providing FDA with a useful excuse to update them anyway. But if the FDA truly believes that companies aren’t adequately disclosing important risks on social media platforms, then it wouldn’t surprise us if it adopts a wholly new approach to enforcement.

To contact the author of this analysis, please email Alexander Gaffney ( agaffney@agencyiq.com).
To contact the editor of this analysis, please email Karen Early ( kearly@agencyiq.com ) or Ashley C. Klein ( aklein@agencyiq.com)

Key Documents and Dates

• FDA Launches Crackdown on Deceptive Drug Advertising
• HHS Statement
• Presidential Memorandum
• Makary video on X