FDA Advertising and Promotion Enforcement Activities: Update
October 17, 2023, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
In August, the Office of Prescription Drug Promotion (OPDP) posted the following enforcement letters on FDA’s website:
- Untitled Letter to Exeltis USA, Inc. re: SLYND™ (drospirenone) tablets, for oral use, MA 40 (Aug. 11, 2023) (Slynd Untitled Letter)
- Warning Letter to AstraZeneca Pharmaceuticals LP re: BREZTRI AEROSPHERE™ (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use, MA 385 (Aug. 4, 2023) (Breztri Waring Letter)
During the same period, the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) posted the following warning letters:
The Slynd and Breztri letters are the second and third enforcement letters OPDP has issued in 2023. OPEQ and OMDRHO had previously issued 5 letters related to advertising and promotion in 2023. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.
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
Slynd Untitled Letter (August 2023)
OPDP’s untitled letter to Exeltis USA, Inc. (Exeltis) states that a social media post on Facebook’s newsfeed misbrands Slynd, a progestin indicated for use by females of reproductive potential to prevent pregnancy, by making false or misleading claims and representations about the drug’s risks and efficacy. OPDP further alleges that Exeltis did not submit the promotional material to FDA under cover of Form FDA-2253 at the time of initial publication, as required by FDA regulations.
False or Misleading Risk Presentation
OPDP alleges that the post “presents claims and representations about the benefits of Slynd but fails to communicate any risk information” (emphasis by OPDP). OPDP further states that, due to this omission, the post “fails to provide material information about the consequences that may result from the use of Slynd and creates a misleading impression about the drug’s safety.”
False or Misleading Claims About Efficacy
OPDP alleges that the post’s description of Slynd as “estrogen-free birth control with periods on a schedule” overstates the drug’s efficacy “by claiming patients will have a ‘period,’ or bleeding, that is predictable and ‘on a schedule’ when this has not been demonstrated.” OPDP states that, according to the Slynd prescribing information (PI), in two studies, the majority of patients experienced decreased “scheduled bleeding” during treatment. Additionally, the PI states that patients may “experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use.”
Failure to Submit Under Form FDA-2253
FDA regulations require any advertising devised for promotion of a prescription drug product to be submitted to OPDP at the time of initial publication and accompanied by a completed transmittal Form FDA-2253. The Slynd Untitled Letter states that a copy of the post was not submitted to OPDP.
Breztri Warning Letter (August 2023)
OPDP’s warning letter to AstraZeneca Pharmaceuticals LP alleges that a professional sales aid misbrands Breztri by making false or misleading claims and/or representations with respect to the drug’s efficacy. Breztri is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
False or Misleading Claims About Efficacy
OPDP alleges that the following claims, which cite publications analyzing data from the Efficacy and Safety of Triple Therapy in Obstructive Lung Disease (ETHOS) trial, are misleading:
- “DIFFERENCE OBSERVED IN TIME TO ALL-CAUSE MORTALITY (OVER 52 WEEKS),” in conjunction with a graph titled, “SECONDARY ENDPOINT STUDY 1: Time to all-cause mortality in the ITT population”;
- “An observed relative difference with BREZTRI vs LAMA/LABA was shown in data published in 2020/2021, including in the New England Journal of Medicine”; and
- "49% Observed relative difference with BREZTRI vs LAMA/LABA.”
OPDP states that these claims “suggest that Breztri treatment has been shown to have a positive impact on all-cause mortality (ACM) and reduce the risk of death in COPD patients.” According to OPDP, the ETHOS trial does not allow for conclusions to be drawn from the ACM data, because the study did not show statistically significant results on endpoints higher in the analysis hierarchy and abrupt withdrawal of patients from inhaled corticosteroids (ICS) may have been a confounding factor. OPDP states that the results “do not exclude the possibility that the benefits in ACM claimed above may be attributable to chance or to the withdrawal of ICS and not due to Breztri.”
OPDP acknowledges that a statement below the graph provides that “[t]hese results are observational in nature, and any comparisons between treatment arms should be interpreted with caution,” but concludes that this “does not mitigate the misleading impression.”
In addition, OPDP takes issue with the presentation of the claim “20% EXACERBATION REDUCTION VS ICS/LABA[;] rate ratio: 0.80[;] P=0.02”. OPDP did not agree that the clinical trial data demonstrated a statistically significant reduction in severe exacerbations and, therefore, asserted that the presentation of this claim with a p-value of 0.02 created a misleading impression of statistical significance.
CDRH Office of Product Evaluation and Quality (OPEQ) and ORA Office of Medical Device and Radiological Health Operations (OMDRHO)
King Systems Corp. Warning Letter (August 2023)
FDA’s warning letter to King Systems Corp., dba Ambu, Inc. (“Ambu”), which arose out of an inspection and was co-signed by OPEQ and OMDRHO, addresses the King LTS-D branded supraglottic airway with gastric access lumen.
FDA alleges that statements on the firm website promote the device with an intended use for pediatric populations weighing less than 5 kg, 5-12 kg, 12-25 kg, and 25-35 kg. However, according to FDA, the cleared indication for use is for adult patients. FDA states that “[u]se of this device in a pediatric population raise[s] different questions of safety and effectiveness that may lead to patient adverse events” and asks Ambu to “remove these unsupported performance claims . . . [or] provide a 510(k) with this proposed indication for use.”
Tesla BioHealing Warning Letter (August 2023)
FDA’s warning letter to Tesla BioHealing, Inc. (Tesla BioHealing), issued by OPEQ and OMDRHO, arose out of an inspection, during which an investigator determined that the firm is a manufacturer of the Tesla MedBed Generator and Tesla BioHealer medical devices. The firm website states that “Tesla BioHealing OTC Medical Devices create their own environments of pure Life Force Energy, offering a much higher concentration of this natural healing force than is available in everyday environments” and that “[o]nce the body is given enough Life Force Energy to work with, cellular self-repair mechanisms can begin to activate much faster and more profoundly than previously was possible.” FDA alleges that these products are adulterated and misbranded because they are marketed under an exemption from 510(k) premarket notification without approval or clearance but are intended for a use different from the intended use of the relevant 510(k) exemption.[1]
By regulation, devices classified under 21 C.F.R. § 890.5500 (“Infrared lamp”) “emit[] energy at infrared frequencies . . . to provide topical heating” and are exempt from premarket notification. According to FDA, the Tesla MedBed Generator and Tesla BioHealer devices “do not have a heating element and are marketed for different intended uses, including treatment of a wide variety of chronic illnesses and diseases, such as terminal cancers, stroke paralysis, Lyme Disease, Alzheimer’s/Dementia, and Epilepsy.”
FDA also cites additional intended uses and disease claims from the company website, including claims about “Life Force Energy Early Signs of Efficacy” in the form of “Pain Reduction,” “Increased Libido,” and “Normalized Glucose Levels.” Per FDA, the website states that “[i]n addition to these early signs of efficacy, it is likely you will also note rapid improvements that are specific to your condition.”
FDA goes on to cite other examples of product promotion. For example, according to FDA:
- Finished product labels for the Tesla MedBed Generator and Tesla BioHealer for Adults include indications to “[r]educe pain” and “[p]romote blood circulation with Natural Life Force Energy.”
- Finished product labels for the Tesla BioHealing BioHealer Alpha and the Tesla BioHealing BioHealer Plus include statements that the product “generates a biophoton field to energize brain and other organs of the body to increase energy, reduce pain, improve blood circulation, and improve life quality of the user.”
- Promotional brochures for the Tesla BioHealing devices include various disease claims about the “Known Benefits of Life Force Energy.”
FDA concludes that “[b]ecause there is evidence that the Tesla MedBed Generator and Tesla BioHealer medical devices are intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5500, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.”
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices group.
[1] The letter also includes allegations that (1) the methods used in, or the facilities or controls used for, the devices’ manufacture, packing, storage, or installation are not in conformity with current good manufacturing practice requirements, and (2) the firm has not listed the proprietary names “Tesla MedBed Generators” and “Tesla BioHealers” on any registration and listing information provided to FDA. These allegations are omitted from this discussion.
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