FDA Advertising and Promotion Enforcement Activities: Update

During the fourth quarter of 2025 FDA’s Office of Prescription Drug Promotion (OPDP) posted four untitled letters and no warning letters.

• Untiled Letter to Daiichi Sankyo, Inc. re NDA 211810 TURALIO® (pexidartinib) capsules, for oral use (November 24, 2025) (Turalio Untitled Letter)
• Untitled Letter to Karuna Therapeutics, Inc., a Bristol Myers Squibb Co. re NDA 216158 COBENFY™ (xanomeline and trospium chloride) capsules, for oral use (December 15, 2025) (Cobenfy Untitled Letter)
• Untitled Letter to BeOne Medicines USA, Inc. re BLA 761232 TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use (December 17, 2025) (Tevimbra Untitled Letter)
• Untitled Letter to Esperion Therapeutics, Inc. re NDA 211617 NEXLIZET® (bempedoic acid and ezetimibe) tablets, for oral use (December 19, 2025) (Nexlizet Untitled Letter)

During the same period, the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted one warning letter relating to the advertising and promotion of medical devices.

• Technological Medical Advancements LLC re Diowave 250 WLS and Diowave 100 WLS laser system (September 26, 2025) (TMA Warning Letter)

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. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) did not post any warning letters relating to the advertising and promotion of biologics during this period.

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.

Office of Prescription Drug Promotion (OPDP)

Untitled Letter to Daiichi Sankyo, Inc. (Issued November 24, 2025)

OPDP’s letter to Daiichi Sankyo, Inc. (Daiichi Sankyo) alleges that a direct-to-consumer (DTC) video for Turalio is false and misleading.  Specifically, OPDP alleges that before-and-after images in the video of a patient gardening “suggest[s] that all patients with [tenosynovial giant cell tumor (TGCT)] treated with Turalio will experience a complete resolution of disease and will be able to return to daily activities (e.g., gardening), without limitations from TGCT stopping them.” However, OPDP states that according to the clinical studies the overall response rate “does not adequately support the suggestion that all patients would be able to live as they did prior to their TGCT diagnosis.”

Furthermore, OPDP states that the totality of the claims and presentations misleadingly suggest that treatment with Turalio will improve patients’ emotional and physical functioning and may allow them to return to their original selves “when this has not been demonstrated.”  OPDP acknowledges the video includes a disclaimer that “[o]utcomes may vary and are dependent on each patient’s clinical profile and history.” However, it concludes that “inclusion of this statement in this promotional communication does not correct or mitigate the misleading suggestions regarding Turalio treatment.”

Untitled Letter to Karuna Therapeutics, Inc. (Issued December 15, 2025)

OPDP’s letter to Karuna Therapeutics, Inc. (Karuna) alleges that a TV ad for Cobenfy is false or misleading because the “claims and presentations create a misleading representation that treatment with Cobenfy will improve both the positive and negative symptoms of schizophrenia” despite the fact that “the pivotal trials supporting the schizophrenia indication for Cobenfy were not designed to capture changes in positive or negative symptoms as distinct groups.” 

Specifically, OPDP refers to a voiceover stating that “Cobenfy showed overall improvement across a range of schizophrenia symptoms . . .” made in conjunction with on-screen text that it offers “improvement ACROSS A RANGE OF SYMPTOMS” and an image of overlapping circles with the text “POSITIVE SYMPTOMS” and “NEGATIVE SYMPTOMS.” OPDP explains that the primary efficacy measure was a “change from baseline in the Positive and Negative Syndrome Scale” and that the “pivotal trials for Cobenfy were not designed to evaluate the efficacy of the drug in treating negative symptoms because the patients in the studies were experiencing acute exacerbations of schizophrenia, which can confound the assessment of improvements in negative symptoms.”

Additionally, OPDP states the ad creates a misleading impression about the indication for Cobenfy due to the inclusion of a voiceover stating, “[i]f you still have symptoms, be bold and ask your healthcare provider about Cobenfy . . . .” OPDP explains this claim “misleadingly suggests that Cobenfy has efficacy in treatment-refractory cases of schizophrenia, when this has not been demonstrated.” Further, OPDP claims the ad misclassifies Cobenfy by stating it is “not an antipsychotic” even though Cobenfy is considered a member of the antipsychotic drug class based of its therapeutic indication for treating schizophrenia and its effects on psychotic symptoms, not its mechanism of action.

Untitled Letter to BeOne Medicines USA, Inc. (Issued December 17, 2025)

OPDP’s letter to BeOne Medicines USA, Inc. (BeOne) alleges that two “Teams Backgrounds” promotional communications for Tevimbra are false or misleading because they make representations about the indication of Tevimbra for the treatment of upper GI cancers, but fail to include risk information and material information regarding Tevimbra’s full FDA-approved indication.

OPDP alleges that the backgrounds include representations about the use of Tevimbra with the claim “BRINGING MORE TO THE TABLE IN UPPER GI CANCERS” in direct conjunction with a visual of a long, curving dinner table similar to the upper digestive tract and the claim “APPROVED IN CERTAIN UPPER GI CANCERS.” However, the backgrounds do not include any risk information about Tevimbra. OPDP states that by “omitting the major side effects associated with Tevimbra, the branded backgrounds fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety.”

Additionally, OPDP alleges the branded backgrounds fail to provide material information regarding Tevimbra’s full FDA-approved indication, thereby presenting a misleading impression about the drug’s FDA-approved indication. The indications and usage section of Tevimbra’s FDA-approved prescribing information states:

“TEVIMBRA in combination with platinum-containing chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).”; “TEVIMBRA, as a single agent, is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.”; “TEVIMBRA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2- negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1).”

OPDP states that the branded backgrounds suggest that Tevimbra can be used for the treatment of upper GI cancers, but they do not include the full indication, as set forth above.

Untitled Letter to Esperion Therapeutics, Inc. (Issued December 19, 2025)

OPDP’s letter to Esperion Therapeutics, Inc. (Esperion) alleges that a DTC connected TV (CTV) broadcast ad for Nexlizet is false or misleading for two reasons.

First, OPDP alleges that the ad includes claims and presentations that misleadingly suggest that bempedoic acid, a component of Nexlizet, is the only nonstatin “FDA approved to lower bad cholesterol and reduce the risk of heart attack in statin intolerant patients” and “proven to reduce the risk of heart attack in patients who are unable to take recommended statin treatment” (i.e., “NEXLIZET may help. It contains the only nonstatin FDA approved ...,” “The bempedoic acid ingredient of NEXLIZET is the only nonstatin proven to reduce the risk of heart attack ... ,” and “Can't take a statin? Make NEXLIZET happen.”). OPDP alleges that because certain PCSK9 inhibitors are also approved to lower LDL cholesterol and reduce the risk of major adverse cardiovascular events such as heart attack in patients who are statin intolerant, the ad is misleading.

Second, OPDP claims the ad is misleading because “the compelling and attention-grabbing visuals” interfere with the comprehension of the major statement. FDA specifically refers to “cartoon-like ‘lipid lurkers’ entering and exiting the various scenes in an artery while swimming around and towards the viewer, diving, doing flips, collecting and sticking to arterial walls, and talking to one another in the ‘arterial environment’ where blood is constantly flowing.”

Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH)

Technological Medical Advancements LLC (Issued September 26, 2025) 

OPEQ’s warning letter to Technological Medical Advancements LLC (TMA), regarding the company’s Diowave 250 WLS and Diowave 100 WLS laser systems, arose out of an April 2025 inspection of the company and a review of TMA’s website, along with a number of product brochures and operating manuals. OPEQ alleges the inspection revealed that TMA is marketing Diowave 250 WLS and Diowave 100 WLS laser systems for uses that exceed the scope of the 510(k) exemption for infrared lamps without submitting a required 510(k) premarket notification to FDA. 

According to OPEQ, infrared lamps classified under 21 CFR 890.5500 are exempt from premarket notification. Such devices are “intended for medical purposes that emits energy at infrared frequencies to provide topical heating.” However, FDA alleges “there is evidence that the Diowave 250 WLS and Diowave 100 WLS operate using a different fundamental scientific technology than that generic type of device.” Specifically, OPEQ explains “the Diowave 100 WLS and Diowave 250 WLS laser systems appear to utilize stealth micro-pulse laser technology, which does not provide topical heating.” OPEQ points to the following claims as evidence of this point: 

• “All heat during a stealth treatment is inhibited, allowing for deep penetration as there is no heat during treatment.”
• “Diowave is pleased to reveal the Stealth Micro-Pulsed Laser System™. SMPLT allows you to hold a hand piece static over a focal pathology without heating tissue.”
• “Our Stealth Micro-Pulse Technology allows care providers to treat various pathologies by Micro-Pulsing at appropriate power levels without introducing heat.”
• “The Doctor can remove all heat from the laser beam allowing him to hold the laser directly over the injury for an indefinite amount of time.”

Additionally, OPEQ alleges the Diowave 250 WLS and Diowave 100 WLS laser systems are intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.550. Infrared lamps classified under 21 CFR 890.550 “emit energy at infrared frequencies (approximately 700 to 50,000 nanometers) to provide topical heating and are intended for medical purposes including, but not limited to, temporary increase in local blood circulation and temporary relief of: muscle spasms, minor joint pain and stiffness, minor muscle pain and stiffness, and minor arthritis pain.” OPEQ alleges “there is evidence that the Diowave 250 WLS and Diowave 100 WLS are intended for uses that are different from the intended use of the type of devices classified under 21 CFR 890.5500 Infrared Lamp.” OPEQ points to the following claims, among others, as evidence of this point: 

• “[A] painless, non-surgical, and side-effective way to treat conditions previously refractive to traditional medical care”
• “[T]reatment of various pathologies, including those refractive to traditional therapy”
• “Because laser therapy is the only treatment in medicine that actually heals living tissue, most conditions respond favorably to repeated laser therapy treatments. It has been proven to deliver results when all other forms of insurance-based medicine have failed.” 
• “[R]esults come from the laser’s ability to stimulate tissue growth and repair…results in accelerated wound healing with a dramatic decrease in…inflammation, and scar tissue formation.”

OPEQ also notes that TMA has an existing clearance (K121363) under 21 CFR 890.5500, but that “promotion of the device provides evidence that the device is intended for conditions beyond the indications for which it was cleared” and that this “constitutes a major change or modification in the intended use.” Further, OPEQ alleges the claims demonstrate that TMA “made a technological change to the device that could significantly affect the safety or effectiveness of the device” which constitutes “a significant change or modification for which a new premarket notification is required.”