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. Back in September I posted an article on this website asking the question: “Where Have All the Drug Ads Gone?” Turns out that they are like the Energizer Bunny commercials…still going strong…at least for now! The FDA’s “Crackdown on Misleading Pharmaceutical Advertisements” has still not taken hold!
What is Wrong With the United States?
The United States is distinctive in many ways, but at least one unique characteristic may change in the coming months. We are one of just two countries in the world that permits prescription drug advertisements to be beamed directly to consumers–that is, to patients rather than doctors. (The other, if you were wondering, is New Zealand.)
Back in September, the Food and Drug Administration sent thousands of letters to pharmaceutical firms and issued a press release declaring a crackdown on deceptive drug advertising. At the same time, the agency issued about a hundred cease-and-desist orders to companies with ads it deemed deceptive.
At Long Last…Drug Ads’ Death Was FDA Sanctioned:
We could not have been more delighted. After all, we’ve been complaining for years about prescription drug ads on television and online. Consequently, we were thrilled to read that:
“By closing loopholes and stepping up enforcement, the FDA will protect patients, safeguard public health and hold the pharmaceutical industry accountable.”
Hopefully, this new action will have an impact. We are getting impatient, though. The letters that the FDA sent in September requested a response within 15 days. Has the agency received meaningful answers? We don’t know.
The LONG History of Drug Advertising:
In some ways, direct-to-consumer (DTC) drug advertising goes back a long time. In the 19th century, traveling salesmen would put on shows to peddle patent medicines wherever they went. Back then, there was no FDA nor even any television.
By the mid-20th century, TV offered a wonderful opportunity for companies to promote their over-the-counter products. If you are old enough, you can remember ads for Excedrin, Alka-Seltzer, Preparation H and Listerine, among other products. But people were not accustomed to advertisements for prescription drugs.
The Beginning of Prescription Drug Ads:
The first TV ad for a prescription medicine was aired on May 19, 1983. It was not elaborate, merely telling people that if they were taking prescription ibuprofen (Motrin), they could get it cheaper as Rufen. No description of what it was for or any side effects. Just price.
Pharmaceutical manufacturers and regulators alike were disconcerted by this novel idea, and a moratorium on DTC ads went into effect in September 1983. The FDA changed its mind and permitted such commercials in 1985, but it required full disclosure of side effects. Perhaps that’s why there was not an immediate rush to take advantage of this new opportunity.
The Floodgates for Direct-To-Consumer Advertising Opened:
Things changed in 1997, though. The FDA relaxed the requirement on full disclosure, so long as the ad made “adequate provision” for people to get more information through a website or toll-free number, for example.
With that loophole, the floodgates opened. Spending on DTC prescription drug ads went from $360 million in 1995 to $10.8 billion last year. On some shows, it seems as if nearly every other commercial is for a prescription medication to treat psoriasis, diabetes or rheumatoid arthritis.
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. I was hoping that some of the most misleading commercials would disappear quickly and that many others would be curtailed.
As far as I can tell, as of November 10, 2025 that has not happened.
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 months and months and months. Hopefully it will not take years!
At the bottom of my last article I asked:
Are Prescription Drug Ads Gone?
The answer at the time of this writing the answer is NO!
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
I would like to ask you, dear reader, to stay tuned and vigilant. If you see any changes over the next several months, please let me know. The FDA moves slowly, so let’s remain patient. But let’s not be complacent.
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 months ahead. Thank you for supporting our work!
