FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications

On Tuesday, September 9, 2025, the Department of Health and Human Services (HHS) and FDA both issued press releases and a fact sheet launching a crackdown on deceptive drug advertising. In the FDA's press release, the Agency stated that it had issued “thousands of letters” regarding direct-to-consumer pharmaceutical advertising in addition to “approximately 100 cease-and-desist” letters. Nearly two months later, we've had the opportunity to read and analyze the press releases, fact sheet, and letters and have developed broader insights based on the information in the available letters.

Enforcement Timeline

As of October 28, 2025, FDA has posted a total of 61 enforcement letters directed at prescription drug and biologic advertisements. The enforcement actions include 8 Warning Letters and 53 Untitled Letters. Before providing additional analysis, let's recap the timeline of events:

FDA issued 60 enforcement letters on September 9 with one additional letter posted on September 26. We now understand the September enforcement letters to represent the “cease and desist” letters referenced in the FDA's Press Release. The “Conclusion and Requested Action” section of these letters states that companies should “cease and desist” promotional communications that are misleading – a change from letters issued prior to September which directed Firms to “cease any violation.” The FDA has posted letters in two batches – On September 16, the Agency posted 49 letters targeting direct-to-consumer promotional communications and on September 25, an additional 11 letters were posted targeting HCP-directed communications. One letter was posted on September 26 for a DTC television ad but it's important to note that this letter does not appear to be part of the September 9 compliance effort. Finally, the Agency issued 58 Warning Letters to online pharmacies regarding website promotion of compounded products.

In addition to the enforcement letters, the Agency has issued an unknown number of Change of Opinion letters. The “thousands” of letters cited in the FDA press release appear to refer to the “Dear Pharma” letters sent to all Application holders in conjunction with the September 9 FDA Press Release.

A Caveat on Enforcement Volume

Before discussing the high-level trends observed in the publicly available letters, it's important to contextualize the volume of letters relative to prior eras of FDA enforcement. First, we do not yet know if all the letters issued by the Agency on September 9 are available on the FDA website. FDA messaging has clearly signaled an enforcement focus on direct-to-consumer marketing, but letters issued on September 9 target both DTC and HCP-directed promotion. Second, our review shows that multiple letters include objections against same or similar claims and presentations for the same product. Roughly one-third of the September 9 letters are duplicative and represent a shift in FDA enforcement procedures. In the past, any promotional materials employing same or similar claims and presentations for a product that was the subject of a compliance letter would be addressed during the enforcement clean-up process. The Agency has opted to issue numerous duplicate letters to Sponsors for same or similar presentations. If nothing else, this has produced an artificially inflated number of enforcement actions.

Focus on Efficacy and Benefit Violations

One clear trend that has emerged in our review of the September compliance letters is the Agency's renewed focus on efficacy and benefit claims. Approximately 47 of the 61 posted letters cite overstatement of efficacy, false or misleading presentation of benefit or efficacy, or another similar violation related to efficacy claims. Most violative presentations are due to unsubstantiated efficacy claims either in the form of inadequate evidence as demonstrated in clinical trials or an overstated magnitude of benefit in the form of treatment effect or time to onset of action. Other common benefit claims cited by the Agency focus on unsubstantiated quality of life benefits where patients were shown performing tasks and activities that a patient with the condition would not normally be expected to perform, statements or presentations implying that patients could return to their pre-diagnosis condition, or presentations suggesting complete resolution of a patient's condition when the product had not been demonstrated to do so. While the Agency's recent messaging has focused its ire on the presentation of risk in direct-to-consumer advertising, these letters clearly signal that the Agency is equally focused on efficacy and benefit claims and intends to ensure that presentations of product effectiveness are not overstated or broadened.

CCN Standards Remain Murky

Of the 61 letters issued in September, 38 targeted direct-to-consumer television advertisements. As expected with such a high number of television ad letters, FDA cited violations of the Clear, Conspicuous, and Neutral (CCN) Final Rule in roughly 25 instances. Most of the violations described distracting elements or competing visuals during the presentation of the major statement. Other CCN violations focused on the prominence, contrast, and readability of supers and the appropriate application of the dual modality requirement. A review of the cited tv ads that are still available on the internet reveals some common characteristics. In most cases, the cited television ads include five or more scene changes during the presentation of the major statement. These scenes included not only active characters and animals within the scene but also noticeable camera movements including zooming, panning, or swooping crane shots.

Despite the high volume of CCN violations, the Industry is still not any closer to understanding FDA's standards with regards to the presentation of the major statement. A review of the television ads that were not cited for CCN violations reveals the Agency's inconsistencies in evaluating and applying CCN standards. Some television ads that received compliance letters but were not cited for CCN violations shared similar visual characteristics during the presentation of the major statement as the tv ads that were cited for CCN violations. In many cases, during the presentation of the major statement, non-cited television ads included approximately four to five scene changes and several also included noticeable camera movements within the shots. Background elements that were cited as distracting or competing visuals in some ads were ignored in others. It's worth noting that many of the tv ads that were not cited for CCN violations included slower moving scenes with fewer overall elements during the presentation of the major statement. In some cases, characters shown during ads that were not cited for CCN violations moved noticeably slower during the presentation of the major statement. There are limitations to this analysis, though, as FDA has only posted storyboard versions of the cited ads and many of the video versions of the ads are no longer viewable online making it difficult for Industry to assess the final presentations that FDA deemed violative.

This raises questions of how Industry should apply the CCN requirements. Specifically, FDA should clearly define the meaning of a “scene” and a “scene change.” How many scene changes may be included during the presentation of the major statement before FDA considers it distracting? Can the camera move through or within the shot, or must it remain fixed and focused on a single subject? What elements of a scene are considered distracting and what are not? FDA should define the standard so Industry can apply that standard in a consistent and compliant manner.

What Can You Do Now?

As evidenced by the September enforcement timeline, HHS and FDA were well-prepared to execute their enforcement blitz. This was clearly a well-planned and well-coordinated effort that included not only multiple press releases, announcements, and compliance letters but also a coordinated media effort on the part of the FDA Commissioner's Office. Many of the actions described in the press releases have yet to occur, though. FDA has not yet posted compliance letters targeting prescription drug promotion on social media nor has it announced a notice of proposed rulemaking that will signal impending changes to prescription drug advertising regulations. Industry should not grow complacent during this lull in Agency activity but rather use the time available now to prepare

Here are some steps you can take now:

• Review all television ads to ensure the presentation of the major statement is compliant with the Clear, Conspicuous, and Neutral Final Rule. Ensure scene changes are limited (no more than five) and activity shown during the presentation of the major statement is slowed and not distracting. Avoid any elements, including those in the background, that may be distracting or draw attention away from the presentation of the major statement.
• Audit all core materials to ensure strong evidence is provided to support claims. Remember that disclaimers cannot mitigate the misleading impression created by inadequate data.
• Avoid unsubstantiated quality of life claims or overstated magnitude of benefit presentations. Ensure that patient portrayals in promotional communications, regardless of the use of real patients or actor portrayals, accurately reflect the patient population and treatment effect of the product.