Mark Twain is often quoted to have said something like “Reports of my death are greatly exaggerated.” It would appear that the same could be said for prescription drug ads’ death. Last week I posted an article on this website asking the question: “Where Have All the Drug Ads Gone?” Turns out that they are still going strong…at least for now! Readers have let us know in no uncertain terms that the FDA’s “Crackdown on Misleading Pharmaceutical Advertisements” has not yet taken hold!
FDA Commissioner Announced Drug Ads’ Death…But It Could Take Time:
There was an Opinion piece in the New York Times dated September 13, 2025 by Dr. Marty Makary, MD, MPH. He is the new head of the Food and Drug Administration. It was titled:
“I Run the F.D.A.
Pharma Ads Are Hurting Americans.”
The day before, JAMA (September. 12, 2025) published Dr. Makary’s viewpoint titled:
“The FDA’s Overdue Crackdown on Misleading Pharmaceutical Advertisements”
On September 16, 2025 the insider publication, FIERCE Pharma ran the headline:
“FDA targets Lilly, Novartis, BMS [Bristol Myers Squibb] and more in deluge of marketing letters”
The introduction to the Fierce Pharma essay stated:
“After the FDA announced it was cracking down on what it has determined to be ‘misleading’ or ‘deceptive’ direct-to-consumer pharmaceutical ads, the floodgates have opened.
“In the first few days after the announcement, the agency publicly shared only one of what it said were thousands of letters informing drugmakers of their alleged violations of federal pharma marketing rules: a missive from the Center for Biologics Evaluation and Research (CBER) taking aim at a TV commercial for AstraZeneca’s self-administered FluMist vaccine.
“Around midday Tuesday, however, the Center for Drug Evaluation and Research (CDER) uploaded a flood of both untitled letters and more serious warning letters for public perusal.”
I Jumped the Gun on Drug Ads’ Death:
In many of the letters the FDA sent out in early to mid-September, the agency states:
“Within fifteen (15) working days of receipt of this letter please provide a written response…”
I totally jumped the gun. I thought that drug companies might take prompt action after receiving a tough communication from the Food and Drug Administration. It would appear that they will certainly take two weeks to respond as requested. It could take longer to see a change on television or social media.
An Example of the Language in Warning Letters:
One “WARNING LETTER” sent to Andrew Dudum, Chief Executive Officer of Hims & Hers Health, Inc on September 9, 2025 included this statement:
“You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
“Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them.”
On September 16, 2025 the FDA issued this warning letter to David A. Ricks, CEO of Eli Lilly and Company:
“The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled ‘An Oprah Special: Shame, Blame, and the Weight Loss Revolution,’ regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) and MOUNJARO® (tirzepatide) injection, for subcutaneous use (Mounjaro). The video features Dr. W. Scott Butsch and Dr. Amanda Velazquez, paid consultants (representatives) who ‘receive research funding from companies making GLP-1 drugs.’ The video also features Rhonda Pacheco, Group Vice President of Diabetes and Obesity for Eli Lilly and Company (Eli Lilly). The video originally appeared on ABC as a Primetime Oprah Special on March 18, 2024 and can also be accessed through ABC’s website.
“This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications for Zepbound and Mounjaro that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound and Mounjaro.”
Here is part of the letter to Yeasin Chowdhury, Director of Promotional Regulatory Affairs at AstraZeneca Pharmaceuticals LP regarding commercials for FLUMIST:
“The presentation of limitations and risk information in the TV ad is not reasonably comparable to the presentation of benefits. Specifically, the fast pacing of the risk concepts and the presentation of compelling and attention-grabbing visuals during the presentation of risk information, all of which are unrelated to the risk message, in addition to frequent scene changes, compete for the viewers’ attention and make it difficult for the viewer to adequately process and comprehend the risk information. Moreover, the presentation of the major statement is not presented in a clear, conspicuous, and neutral manner. The loud background music and visual distractions, including numerous scene changes, quick camera movements, and close-ups, interfere with the viewer’s ability to read the SUPERs while processing the audio information disclosing the risks associated with use of FLUMIST. In addition, the SUPERs are not easily seen on screen because the size of the text is relatively small and below the action in the frames. The overall effect undermines the communication of the risk information and the consequences that may result from the use of FLUMIST.
“This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for FLUMIST that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of FLUMIST.”
What Is the Problem with SUPERs?
If that term stumped you, as it did us, it is FDA shorthand for superimposed text that crawls along the bottom of the screen with the risk information. Far too often, the commercials make it seem as if their products are magical. People are seen laughing, dancing, swimming and having a wonderful time.
While these distracting images capture the viewers’ attention, an announcer recites a list of potential side effects as quickly as possible. In addition, there is a list of those side effects appearing on the screen at the same time. Can you read them? The FDA suggests, above, that in the FLUMIST commercials, at least, the text is too small and moves too fast.
Drug companies spend billions on these commercials. What we’ve observed is that Big Pharma does not like to waste money. Some analysts have estimated that the return on investment is 5 to 1. That is to say, for every dollar spent on DTC ads, the company could make back $5.
That could come to a screeching halt if the FDA and the HHS (Department of Health and Human Services) are able to implement a new plan called “Full Safety Disclosures in Drug Ads.”
Will Drug Ads Disappear?
A lot of people were hoping that the FDA would ban drug ads outright. That almost assuredly would have failed. Pharmaceutical company lawyers were prepared to launch an all-out war against such an initiative. The argument would have been based on the First Amendment right to free speech. The courts have supported this strategy in the past, so it would likely have succeeded.
The lawyers at the FDA and HHS have come up with a different approach. Back in 1997, the Food and Drug Administration created a loophole that opened the floodgates for drug ads.
Instead of listing all the safety information in detail, companies could simplify their cautionary statements. It may seem as if the list of potential adverse reactions is long, but if you check the official prescribing information for many medications, you will discover a far more extensive catalog of bad things that could happen. There are boxed warnings for many medicines and lots of precautions and contraindications that are not currently included in most commercials.
Here is where the FDA strategy seems highly creative. By closing the 1997 loophole, companies will have to provide a far more comprehensive and intimidating list of potential hazards. If the agency is monitoring text size and salience of SUPERs, commercials might become much less appealing. That could add so much additional information to commercials that they would no longer be practical or profitable.
It Will Take Time To See Drug Ads’ Death:
How long will it take to see the reduction in prescription drug ads to consumers? It could take two weeks…or longer!
At the bottom of my last article I asked:
Are Prescription Drug Ads Gone?
It will take watching commercials instead of zooming through them as I normally do. Please let us know how many you see compared to the bad old days.
Readers Responded about Drug Ads’ Death this way:
Roger:
“I’ve seen several Jardiance commercials recently, maybe one almost daily on FoxNews, but don’t recall any others meaning a net reduction probably.”
Tom:
“I have not seen any change in the number of commercials by drug companies. There are still a lot on the ABC World News every evening”
Richard:
“Regarding prescription drug ads, no, it seems there are more than ever, especially on CNN at dinner time.”
Margaret:
“We watch nightly news on CBS (or NBC or ABC) every evening while we eat dinner. They are full of drug ads. During the day I tune in to MSNBC and CNN, also full of drug ads. I haven’t noticed any difference. They state enough horrible possible side effects that I would never want to take those drugs.”
Anne:
“Wishful thinking. There are just as many Pharma ads as ever. That’s especially if you watch the evening national news.”
Harry:
“I don’t know what you are watching, but my local channels are chock full of drug ads.”
Tim:
“I haven’t seen fewer people dancing and singing about their prescriptions.”
Michele:
“No, unfortunately the drug ads are still alive and well. One just aired right before I opened this article. I haven’t even noticed a reduction. It would be nice, though, wouldn’t it?”
Final Words:
To borrow from Mark Twain’s purported comment, it would appear that:
Reports of Drug Ads’ Death Are Greatly Exaggerated
Then again, I tend to be impatient. Let’s give the FDA’s letters a couple of weeks to produce results. I would like to ask readers of my articles to stay tuned and vigilant. Please let us kn0w if you see any changes over the next several weeks. Maybe we will see some reductions in October, 2025. If not, let’s get busy contacting the FDA and drug companies that we expect to see fewer faulty drug ads based upon the FDA’s recent warning letters.
Please let friends and family know about the possibility of drug ads’ death so they too can stay vigilant and let us know if there are any changes in the weeks ahead. Thank you for supporting our work!
