This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.
During the third quarter of 2025, the Center for Drug Evaluation and Research (CDER) issued more than 50 Warning Letters and more than 50 Untitled Letters to pharmaceutical companies for drug advertisements.
During the same period, the Center for Biologics Evaluation and Research (CBER) sent one Untitled Letter to AstraZeneca Pharmaceuticals LP regarding FluMist (September 9, 2025) (AstraZeneca Untitled Letter). Prior to this letter, CBER’s Advertising and Promotional Labeling Branch (APLB) had not posted any enforcement letters since 2018.
Additionally, the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted two Warning Letters relating to the advertising and promotion of medical devices.
The Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) did not post any Warning Letters relating to the advertising and promotion of medical devices during this period.
The majority of the Warning and Untitled Letters were issued following a September 9, 2025, presidential memorandum setting forth the Administration’s desire to enhance transparency in direct-to-consumer (DTC) advertising. Along with this presidential memorandum, FDA issued a press release announcing a crackdown on deceptive drug advertising. The press release states that “FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.” Presumably, the Warning and Untitled letters are the “cease-and-desist letters” mentioned in the press release.
The 50+ Untitled Letters primarily address DTC broadcast advertisements. However, some of the letters cite other forms of advertising and promotion, including healthcare professional webpages, healthcare professional visual aids, and DTC print advertisements.
Many of the letters assert that the advertisement or promotional labeling at issue is false or misleading “in violation of the Federal Food, Drug, and Cosmetic Act.” However, the letters do not generally cite specific provisions of the FDCA or FDA regulations. For most of the letters, the grounds cited for why the advertisement or promotional piece is allegedly misleading fall into one of the categories listed below:
- Overstatement of efficacy based on implied claims of improvement in patients’ lives or functioning based on suggestive imagery and/or language, including before-and-after depictions of patients.
- Misleading presentation of risk in the major statement due to “attention-grabbing visuals,” failing to present adequate information in the voiceover and in text (dual modality) or other presentational elements of the major statement.
- Misleading presentation of risk in the major statement due to particular risks or aspects of a risk being omitted.
- Overstatement of efficacy based on implied claims of ease of use or dosing.
- Overstatement of efficacy based on data that is exploratory, such as an extended analysis of a study.
- Presentation of data for oncology products on stable disease, progression-free survival (PFS), overall survival (OS), or other time-to-event endpoints based on a single-arm trial. CDER asserts that the presentations are misleading even with disclaimers about the limitations of the data and the lack of overt claims.
The 50+ Warning Letters seem to have been reserved primarily for obesity products, including both FDA-approved prescription drug products and compounded products, and largely take issue with website content. Some warning letters were also issued for the marketing of compounded methylphenidate, amphetamine, sildenafil, tadalafil, and immune globulin products. The Warning Letters sent to FDA-approved prescription drug manufacturers focus primarily on allegations of false and misleading presentation of risk information and/or the omission of material facts. The Warning Letters sent to entities marketing compounded products tend to challenge claims that “imply that [] products are the same as an FDA-approved product when they are not” (e.g., statements that the compounded products are “generic” versions of the FDA-approved product or that they have the “same active ingredient”). They also challenge claims suggesting that the compounded products have been shown in clinical trials to be safe and effective (e.g., “proven effectiveness” or “clinically proven”).
These Warning and Untitled Letters differ from prior Warning and Untitled Letters to pharmaceutical companies in content and form. For example, the letters generally state that the determinations are those of FDA, as opposed to those of the Office of Prescription Drug Promotion (OPDP) or APLB, and they are signed by the CDER or CBER Director, rather than an OPDP or APLB official. Additionally, the letters state that “FDA requests [Company] take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above.” This language is somewhat different from prior letters, which stated, in the case of OPDP, that “OPDP requests that [Company] cease any violations of the FD&C Act” and did not include language on “immediate action.”
OPEQ’s Warning Letter to Insightra Medical Inc. (Insightra Medical), regarding the firm’s Double Pump and Ultra Intra Aortic Balloon Pump (IABP) Catheter Kits, arose out of an inspection of the firm in January 2025.
OPEQ alleges that the Double Pump and Ultra Intra Aortic Balloon Pump (IABP) Catheter Kit is misbranded because the firm made major changes or modifications to the intended use without submitting a new premarket notification to FDA. Specifically, the firm’s labeling, including promotional materials and information on its website, state that the device is compatible with the Cardiosave IABP Hybrid and the AutoCat 3 despite the fact that the premarket notification under which the device was 510(k) cleared recommended the device only for use with the Datascope System 97, System 98, System 98XT, CS100 and CS300 devices and the Arrow ACAT, AutoCat, AutoCat 2, AutoCat 2 Wave, and KAAT II devices. OPEQ states that listing Cardiosave IABP Hybrid and the AutoCat 3 in the labeling as compatible pump consoles constitutes a significant change or modification to the device’s intended use that requires a new 510(k) clearance. OPEQ explains “[t]he more critical the other device, component, or accessory is to overall system function, the more likely a labeling change regarding compatibility or interoperability could significantly affect safety or effectiveness.” OPEQ concludes that “the pump console is required for the operation of [the] device and therefore has substantial impact on the safety and effectiveness of [the] device. A change to a different pump console that may have different performance characteristics could impact the safety and effectiveness of an IABP catheter.”
FDA’s Warning Letter to SeniorLife Technologies, Inc. (Senior Life) regarding the firm’s SeniorLife.AI mobile application arose out of an inspection of the firm on March 24 through March 26, 2025.
OPEQ alleges that the SeniorLife.AI mobile application is misbranded because the claims on the website for the device indicate it is for intended uses that exceed the scope of the 510(k)-exempt classification for Measuring Exercise Equipment, 21 CFR 890.5360, under which the device was marketed. Specifically, “[m]easuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity,” but OPEQ alleges SeniorLife is “distributing SeniorLife.AI for a different intended use, namely the use of artificial intelligence-based algorithms to screen and ‘pre-diagnose’ mobility and cognitive health conditions.” OPEQ cited website claims such as “[p]roactively identifies fall risk, recommends interventions, and continuously tracks patient mobility over time” and “[c]onducts a 5-minute gaze-based test on an iPad to detect early signs of Alzheimer’s.” OPEQ notes these functions are not the same as measurement of exercises and that “[b]ecause there is evidence that SeniorLife.AI is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5360, it does not fall within the scope of that regulation and requires a premarket submission prior to marketing.”
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.