In a follow-up to FDA’s September 9 announcement that it would crackdown on deceptive direct-to-consumer (DTC) advertising, including issuing approximately 100 cease-and-desist letters, FDA has now (at the time of this blog drafting – September 16) posted 40 Untitled Letters and 35 Warning Letters, all dated September 9, for the public to read.
While it’s difficult to comprehensively get through all of these letters quickly, we thought it might be helpful to provide some initial thoughts on what we are seeing.
Untitled Letters
Several themes emerge from the Untitled Letters posted:
- FDA’s patience with lifestyle montages has worn thin. The Agency singles out ads with happy people and those engaging in social/exercise/family activities which FDA says creates an overall impression that the drug delivers more than treatment for its approved indication.
- FDA objects to the use of subscales and individual items from larger, validated scales to support improvement in quality-of-life measures.
- FDA is concerned with oversimplifying treatment time and effects and exaggerating the benefits of a different route of administration.
- Rapid scene changes, background music, and attention-grabbing visuals that play during the major statement interfere with consumer comprehension. (This is not new.)
What is striking is how short and sharp most of these letters are. With the exception of letters for one drug, all other Untitled Letters lack specific citations to sections of the Federal Food, Drug, and Cosmetic Act (FDCA) or advertising regulations and simply declare that the ads are false or misleading, thus misbranding the drugs making their distribution in violation of the FDCA. These letters also lack section headers that group FDA’s concerns about presentations of safety or efficacy. FDA appears to be formatting these letters in a manner similar to letters issued by DDMAC in the late 1990s, a time cited by the Commissioner as before the FDA’s “regulatory collapse over the past 25 years.”
It’s also worth noting how FDA chose to send these letters. In the past, the Office of Prescription Drug Promotion (OPDP) has typically grouped multiple violative promotional pieces for the same product into a single letter, laying out the shared violations in one place. This time, FDA appears to have split them apart – sending multiple letters on the same product for similar issues, which may artificially amplify the “enforcement blitz.” The forty letters actually represent promotional issues for 29 unique drugs. And, they all appear to have been “signed” and released in a 15 minute period shortly after 5 pm on September 9.
Warning Letters
Many of the recently posted Warning Letters are focused on the booming market for compounded GLP-1 drugs. The Agency flagged website claims that these compounded products were “the same as” or “similar to” the approved brand-name drugs, which FDA alleges is false or misleading because compounded drugs are not reviewed by FDA for safety, effectiveness or quality before reaching patients.
Of the Warning Letters issued to pharmaceutical companies, the greatest concern these bloggers have relates to FDA’s assertions that third party programs that interview company representatives are “promotional communications” that should have been submitted on Form 2253 and require corrective communications.
Both Eli Lilly and Novo Nordisk received Warning Letters over statements made about their drugs during “An Oprah Special: Shame, Blame, and the Weight Loss Revolution.” The letters identify two doctors as representatives who “receive research funding from companies making GLP-1 drugs.” The letters also cite the appearance of company representatives in the video. The letters do not allege that Eli Lilly and/or Novo Nordisk “sponsored” the Oprah Special or further disseminated the videos. According to FDA, Eli Lilly and Novo Nordisk failed to submit these “promotional communication(s)” to FDA on Form 2253.
Consistent with many Warning Letters regarding promotion, FDA has requested (required?) corrective communications:
Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand [DRUGS]; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter. (Emphasis added.)
These bloggers have to wonder – should we expect to see an upcoming Oprah Special addressing FDA’s concerns?
A Word About Company Representatives
It appears that, consistent with its stated focus on “influencers,” FDA is looking more closely at what paid company representatives are saying about company drugs in a variety of platforms. In several letters issued to Phathom Pharmaceuticals, FDA took issue with interviews featuring Kenan Thompson, a “spokesperson for Phathom Pharmaceuticals, Inc. for VOQUENZA (vonoprazan) tablets.” During these interviews Mr. Thompson describes his condition and mentions he is taking Voquenza but does not provide any risk information.
Takeaways
Companies developing their next DTC TV ads would be wise to watch the rough cuts with an eye to how an ordinary viewer experiences the ad. Does the risk narration compete with a montage of mountain biking, family barbecues, and sightseeing trips? Is the text on screen clear and legible? Is the major statement something viewers can realistically process?
In our review, it appears clear that even where an ad meets historical standards for compliant communication of the major statement, FDA may allege that the presentation is false or misleading due to competing visuals and scene changes. These allegations regarding the major statement seem to be “easy” fixes for industry, however.
The more difficult issue to address is how to appropriately represent patients in ads. In reviewing several of the TV ads that are the subject of Untitled Letters, these bloggers note the great care many of the ads take in how patients are presented. Visual representations that patients may not necessarily be defined by the disease they have should not be considered an overstatement of drug efficacy. This does a disservice to both patients and industry.
