FDA Advertising and Promotion Enforcement Activities: Update

FDA Advertising and Promotion Enforcement Activities: Update

February 3, 2022, 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 January, the Office of Prescription Drug Promotion (OPDP) posted the following untitled letter, issued in December 2021, on FDA’s website:

• Untitled Letter to Eli Lilly and Company, re: BLA 761063 EMGALITY® (galcanezumab-gnlm) injection, for subcutaneous use,MA #558 (Dec. 13, 2021) (Emgality Untitled Letter)

OPDP simultaneously posted Lilly’s response to the Untitled Letter (Response to Untitled Letter) and a close-out letter (Close-Out Letter) stating that the concerns contained in the Untitled Letter have been addressed.

In December, the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted the following warning letter:

• Warning Letter to DermaCare Biosciences, LTD. re: Easy Rapid Now COVID-19 Nasal Swab Antigen Test (Colloidal Gold) (Dec. 1, 2021) (COVID-19 Test Warning Letter)

The Emgality Untitled Letter is the sixth and final enforcement letter OPDP issued in 2021.  Collectively, OPEQ and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) posted 19 warning letters related to advertising and promotion in 2021.  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 (OPDP)

Emgality Untitled Letter (December 2021)

OPDP’s untitled letter to Eli Lilly and Company (Lilly) states that two direct-to-consumer broadcast television advertisements (TV Ads) misbrand Emgality, a drug indicated for the preventive treatment of migraine in adults and the treatment of episodic cluster headache in adults.  OPDP alleges that the TV Ads “make false or misleading claims and/or representations about the risks associated with Emgality and omit other material facts.”  OPDP further alleges that Lilly did not submit the TV Ads to FDA at the time of initial dissemination.

False or Misleading Risk Presentation

Both TV Ads state “brought to you by Emgality proud partner of Team USA.”  In the TV ads, Olympic athletes Ryan Murphy and Allysa Seely state the following:

• I do a whole bunch of different things to try to prevent migraine because for me the pain is really tough[.]” (Ryan Murphy TV Ad)
• I’ve leaned on all kinds of doctors and professionals for help[.]” (Ryan Murphy TV Ad)
• When I was younger, I used to say that my brain hurt[.]” (Allysa Seely TV Ad)
• By the time I was in college, migraine [sp.] had me hiding from light and sound, it was isolating[.]” (Allysa Seely TV Ad)

OPDP alleges that the TV Ads contain “representations or suggestions relating to an indication for use of [Emgality]” and therefore must include: (1) risk information and (2) unless adequate provision is made for dissemination of the approved or permitted package labeling, a brief summary of all necessary information related to side effects and contraindications.  OPDP alleges that the TV Ads “fail to communicate any risk information about the product” and “also fail to either provide adequate provision or a brief summary” (emphasis by OPDP).

Omission of Material Facts

OPDP further alleges that the TV Ads are misleading because they do not specify that “EMGALITY is indicated for the preventive treatment of migraine in adults” (emphasis by OPDP).  OPDP states that the Ryan Murphy TV Ad suggests use of the drug for the preventative treatment of migraine (without specifying that it is indicated for use in adults) while the Allysa Seely TV Ad suggests the use of the drug for the treatment of migraine (without specifying that it is indicated for preventative treatment in adults).

Failure to Submit Under Form FDA-2253

OPDP also states that Lilly did not submit the video to OPDP as required under federal regulations.  21 C.F.R. § 314.81(b)(3)(i) requires the submission of “labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement.”  Each submission must be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and a copy of the product’s current professional labeling.

Response to Untitled Letter (December 2021)

In an unusual step, OPDP posted Lilly’s response to the Untitled Letter, as well as the Close-Out Letter issued by OPDP, simultaneously with the posting of the Untitled Letter itself.  Lilly’s response letter begins by stating that the Untitled Letter “is based on a misunderstanding of the content and format of the advertisements.”  “[A]s designed and aired,” the “complete TV broadcast” included three components: (1) migraine disease state information presented by either Ryan Murphy or Allysa Seely, (2) a “billboard” screen referring to Emgality but containing no information about its indication, and (3) a “full-product TV segment (including indication and risk information).”  These components in fact aired “in immediate, sequential fashion.” Lilly states that “without Lilly’s direction,” components 1 and 2 were available for a limited time on the iSpot.tv website without component 3.  Lilly states that it did not ask for such materials to be posted and confirms that they no longer appear on the website.

The company states that the TV broadcast as-aired provided the necessary risk content and the full FDA-approved indication.[1] Additionally, Lilly states that it submitted components 2 and 3 at the time of dissemination but did not submit component 1 because it did not contain a reference to the drug. Lilly acknowledges that its “submission approach may have contributed to confusion.”  Lilly concludes by stating that the TV broadcasts have been discontinued and asking for OPDP to rescind the Untitled Letter.

Close-Out Letter (January 2022)

OPDP’s close-out letter states that “[a]fter review of the information submitted and Eli Lilly’s reasoning, as well as the actions taken by Eli Lilly upon receipt of the Untitled Letter, OPDP believes that the concerns contained in the Untitled Letter have been addressed.”

OPDP states that the content cited in the Untitled Letter “appeared as a cohesive presentation” and therefore both TV Ads referenced were required to include risk information and a brief summary.  OPDP also states that “[w]hat Eli Lilly describes as components 2 and 3 were individually submitted on FDA Form 2253 independent of each other, and neither submission referenced coordination with any other communication.”  In declaring the matter closed, OPDP’s letter acknowledges Lilly’s “intent to create complete TV broadcasts.”  OPDP also acknowledges that Lilly has discontinued use of the three-part broadcasts and that the TV Ads cited in the Untitled Letter are no longer posted online.

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

COVID-19 Test Warning Letter (December 2021)

OPEQ’s Warning Letter to DermaCare Biosciences alleges that the company’s COVID-19 test is adulterated and misbranded because it “is offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.”  Although this alert does not typically cover letters alleging distribution of devices without marketing approval, clearance, or authorization from FDA, this letter makes additional allegations related to the advertising and promotion of the product.

First, OPEQ states that the company’s website and social media websites include statements indicating that the COVID-19 test is “intended for screening or diagnosis of COVID-19,” such as:

• These EasyRapidNow™ tests will be super easy for you to perform and I have firsthand experience. My wife came home Monday evening with a cough and not feeling well. In 15 minutes, we confirmed that she was positive, and we were able to take the appropriate precautions. She works in a doctor’s office and was able to get a PCR test the next day, which confirmed that she was positive. My son and I tested negative and have no symptoms so far. Two days later my son and I tested again, and I was positive, he was negative. We are grateful to have the early warning. This type of early warning will assist you in keeping your workplace and employees safer resulting in fewer business interruptions.”
• Rapid detection of SARS-CoV-2 nucleocapsid antigen in less than 15 minute [sic]”

OPEQ acknowledges that the company’s websites include disclaimers that the tests “enable[] surveillance screening at a population level” and are “not intended for diagnostic use or home use” but states that such disclaimers “are inconsistent with the statements identified above.”  The letter further states, “Based on the statements identified on your website above and your sale of these tests directly to consumers, the FDA has determined that your test is intended for diagnosis of COVID-19 including screening for COVID-19 in asymptomatic individuals without known exposure with the intent of making individual decisions based on the test results (e.g., who may return or what protective measures to take on an individual basis).”

Second, OPEQ states that the company’s LinkedIn site displays the FDA logo alongside information about the COVID-19 test and other products.  OPEQ alleges that such a presentation “may send a misleading message that the FDA favors or endorses your products.” OPEQ also states that “[u]nauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.”

If you have any questions concerning the material discussed in this client alert, please contact the following of our Food, Drugs, and Devices practice.