FDA Advertising and Promotion Enforcement Activities: Update

FDA Advertising and Promotion Enforcement Activities: Update

August 7, 2024, 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.

During the second quarter of 2024 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 two warning letters.[1]

• Warning Letter to Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs re: Second Generation FIT Fecal Immunochemical Test (April 17, 2024) (Pinnacle Warning Letter)
• Warning Letter to Spectrum Medical Ltd. re: Quantum Perfusion Systems Devices (September 29, 2023) (Spectrum Medical Letter)

During the same period FDA's Office of Prescription Drug Promotion (OPDP) did not post any enforcement letters. 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.

CDRH Office of Product Evaluation and Quality (OPEQ) and ORA Office of Medical Device and Radiological Health Operations (OMDRHO)

Pinnacle BioLabs Warning Letter (April 2024)

FDA's warning letter to Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs (Pinnacle Labs), issued by OPEQ and OMDRHO, arose out of an inspection and review of the firm's website. FDA alleges that the inspection revealed that the firm is marketing the Second Generation FIT Fecal Immunochemical Test for a new intended use without necessary premarket approval. According to FDA, the company intended to be a private label distributor of the previously-cleared Fecal Occult Blood (FOB) test, which was cleared as "an aid to detect blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer" and was classified under 21 CFR 864.6550 (occult blood test). FDA alleges that the company modified the cleared device and manufactured a new device, by repackaging the cleared device and replacing the original manufacturer's package insert with the company's own labeling stating that the test is intended for use in colorectal screening. FDA also cites claims in a product brochure and on the firm's website to allege that the company has "modified the previously-cleared device and manufactured a new device, the Second Generation FIT Fecal Occult Blood (FOB) Self-Test, with a new intended use" in colorectal cancer screenings.

FDA notes that similar devices intended for colorectal cancer (CRC) screening are class III devices that require premarket approval, and FDA states that it is "not aware of any data demonstrating the safety and effectiveness of [the] device when intended for use in colorectal cancer screening." Consequently, FDA alleges that the Second Generation FIT Fecal Immunochemical Test is adulterated "because [the] firm does not have an approved application for premarket approval" for the new intended use in effect and misbranded "because the firm did not notify the agency of its intent to introduce the device into commercial distribution."

Spectrum Medical Warning Letter (posted April 2024; issued September 2023)

FDA's warning letter to Spectrum Medical Ltd. (Spectrum Medical) issued by OPEQ and OMDRHO, arose out of an inspection. Based on a review of Spectrum Medical's promotional materials and user manuals for the Quantum Perfusion devices that were collected during the inspection, FDA alleges that the company is marketing "several devices with indications beyond what FDA has cleared in [its] premarket notifications for these devices." Specifically:

• The Quantum Pureflow Centrifugal Pumps were cleared for use in cardiopulmonary bypass (CPB) "surgical procedures lasting 6 hours or less," but FDA alleges that the company markets the pumps "for use for 29 days." FDA also alleges that, though the pump is cleared with an indication for open cardiac procedures, the promotional materials market the devices for uses beyond open cardiac procedures, specifically procedures in the Intensive Care Unit (ICU) and procedures performed during patient transport.
• The Quantum Roller Pumps and Quantum Power Supply Lite were cleared for "use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment." However, FDA alleges the company lists the Quantum Roller Pumps and Quantum Power Supply Lite as part of the extracorporeal life support system despite the fact that "[n]either of these devices have been cleared with indications for any other form of extracorporeal life support (ECLS), other than CPB." Additionally, FDA alleges that promotional materials market the Quantum Roller Pumps as part of the "portfolio" for uses beyond cardiopulmonary bypass procedures, specifically procedures in the ICU and procedures performed during patient transport.
• The Quantum SuperPAC with Side Port Technology and Quantum SuperPAC - Dual Lumen Technology was cleared for use "during extracorporeal life support procedures for periods of maximum 6 hours," but FDA alleges the promotional materials do not indicate "that the device is indicated to be used only up to 6 hours."
• The Quantum Ventilation Module and Quantum SuperPAC Tubing Set are listed in promotional materials under "Flexible ECLS Solutions for the ICU and Patient Transport." However, FDA alleges the products are not cleared for "patient transportation or use in the ICU."
• FDA alleges that "the Charlotte Frame Configuration is being marketed with a different indication (i.e., ECLS other than CPB) than the frames cleared" under the submission for the Quantum Pump Console. FDA states that "frames that cannot safely and reliably support the configuration of devices needed for ECLS procedures other than CPB, raise serious public health concerns when used for those procedures, because failure of the frame to safely hold the devices during transportation or treatment of patients could result in serious patient harm or death."

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device group.

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