FDA's Crackdown on DTC Advertising: What Industry Needs to Know

By Rebecca Zadaka

On September 9, 2025, President Trump issued a Presidential Memorandum directing the Secretary of Health and Human Services (HHS) to take action so that direct-to-consumer (DTC) prescription drug advertisements present clearer, more comprehensive risk information, in an effort to make these ads more transparent and accurate. The memorandum also called on the U.S. Food and Drug Administration (FDA) to strengthen enforcement of prescription drug advertising requirements. FDA followed with hundreds of cease-and-desist letters to industry, as well as a record number of untitled letters. We previously examined what this unprecedented enforcement wave signaled for industry in FDA Sends 100 Cease-and-Desist Letters: A Warning to Industry. In this follow-up, we take a closer look at what FDA’s actions reveal about its current priorities.

So what exactly has FDA been targeting in its letters, and what does industry need to know?

September 9 Saw a Spike of Untitled Letters

The surge of untitled letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) marks the agency’s most aggressive posture in years. On September 9 alone, OPDP sent 46 Untitled Letters to industry, more than double the number sent in the previous 5 years combined. Certainly, this is a clear signal to industry to ensure advertisements are compliant, but the letters themselves give a window into what FDA has been concerned about.

While most of these letters targeted DTC pharmaceutical television ads, many also addressed other promotional materials, such as webpages, newsletters, sales aids, and exhibit booth panels. These materials were aimed at both consumers and healthcare professionals. FDA cited a range of violations, including claims based on studies that did not support the promotional statements, omissions or inadequate presentation of material risk information, and comparative claims lacking substantiating data.

Many Letters Pertained to DTC Pharmaceutical TV Advertisements

Almost all of the letters concerning DTC TV advertisements cited, at least in part, visuals that impair the audience’s ability to comprehend the risk information. FDA often noted that “frequent scene changes and other competing modalities,” such as “background music compete for the consumer's attention”, and “compelling, attention grabbing visuals during the presentation of the major statement ... interfere with comprehension of the major statement.” Several of the recent letters were sent on this basis alone.

Another recurring issue in the majority of the letters was the tonal discrepancy between the audio and visual elements of a drug ad and the seriousness of the risks being described. While it is common for pharmaceutical commercials to depict upbeat imagery that contrasts with the conditions or side effects described, FDA has made clear that such inconsistencies can be misleading.

For example, in a letter to Alnylam Pharmaceuticals, Inc., FDA cited a DTC television commercial for AMVUTTRA® (vutrisiran) injection that featured two patients extensively traveling and engaging in activities with their families. The ad showed one patient receiving tickets from a physician that led to scenes of whale watching, attending a football game, and visiting a nature park. The second patient was shown attending a concert and riding a gondola up a mountain. Accompanying voiceovers described Amvuttra as the patient’s “ticket” to a different journey. There were also voiceovers stating things such as Amvuttra is the patient’s “ticket” to a different journey.

Despite these hopeful and cheery visuals, FDA states that,

The totality of these claims and presentations misleadingly suggests that patients treated with Amvuttra can be carefree regarding the effects of cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) and the burdens commonly associated with the disease or will be able to live as they did prior to their ATTR-CM diagnosis, when this has not been demonstrated in the clinical trial for Amvuttra. The totality of these claims and presentations also misleadingly suggests that treatment with Amvuttra will broadly improve a patient’s overall quality of life when this has not been demonstrated. [emphasis added]

Several other untitled letters expressed similar concerns.

What Are Some Things Industry Should Keep in Mind?

Drug manufacturers may wonder whether they're in the clear if they add the full safety information and appropriate disclaimers. The answer is always that any information that is misleading cannot be corrected by including accurate information. This is highlighted in another letter, where FDA states that the ad suggests the drug’s method of therapeutic action is fully understood, when that is not the case. FDA even notes that the ad does include a statement on the screen that the mechanism of action is not fully understood. Despite the inclusion of this statement, the misleading nature of the rest of the advertisement is not mitigated or remedied. This is something all promotional content creators need to remember, especially in light of the impending regulatory changes: it’s not just about making sure the relevant information is there or even fully there. The entirety of the ad must align with the important safety information, and all data cited or used to support a claim must be substantiated and accurate.

How Gardner Law Can Help

What does all of this mean for industry? It means that FDA is looking carefully at all types of promotional materials, not just those that are DTC, and while there have not been any warning letters for medical devices issued since September 9, that does not mean that the focus will remain on pharmaceuticals. There is likely going to be continued scrutiny of all types of promotional materials, both DTC and professional-facing, and manufacturers of both drugs and devices should be on alert for all types of materials they are creating ensure that they are compliant.

At Gardner Law, we guide pharmaceutical and medical device companies through the complexities of advertising compliance, promotional material review, and interactions with the FDA. Our team offers strategic advice on risk disclosures, claim substantiation, and digital strategy. If you're unsure how recent changes might impact your current strategy, contact us so we can help you evaluate and adapt.