As a child I loved a story in the book, One Thousand and One Nights as told by Scheherazade. It’s also referred to as the Arabian Nights. Perhaps you remember the story about the old, poor fisherman who pulled up a sealed bottle. Curious, he pulls the stopper out and – bam! An enormous genie appears. This scary spirit has been trapped in the bottle for centuries. He’s angry and threatens to kill the poor fisherman! What will the fisherman do? This could also be a tale of television drug commercials. What will the FDA do?
Can the FDA Get the Scary Genie Back in the Bottle?
The twist in the Arabian Nights story is that the fisherman thinks quickly and tricks the genie to get back in the bottle. He does this by asking how such a giant genie could fit into such a small bottle.
Being arrogant and anxious to show off, the genie shrinks and returns to the bottle, just to prove that he could indeed fit. The moral: you can’t put a genie back in a bottle unless it cooperates. Will drug companies cooperate to control television drug commercials?
That is the tricky situation the Food and Drug Administration finds itself in. Up until the last few years of the 20th century, there were no advertisements for prescription drugs.
Famous Old OTC Television Drug Commercials:
In the old days, radio and television shows featured commercials for over-the-counter headache products, heartburn medicine and hemorrhoid remedies. Here are just a few oldies:
Alka-Seltzer:
There was the Plop, Plop, Fizz Fizz ad for Alka-Seltzer.
Preparation H:
Here is Bryan Cranston (of Breaking Bad fame) pitching Preparation H with “oxygen action”.
Tums:
And let’s not forget the iconic Tummm Tum-Tum commercial of the 1980s.
Pharma Execs Once Rejected Television Drug Commercials:
Back in the early 1980s, the FDA commissioner came right out and asked if pharmaceutical manufacturers were contemplating television drug commercials for prescription medications. The almost universal answer was “No, that would be a terrible idea” (STAT, Dec. 11, 2015).
Drug company execs went further in response to questions from Representative John Dingell of Michigan.
Representatives from Eli Lilly, Upjohn and Schering-Plough made it clear that television drug commercials would be “detrimental,” “disruptive,” and not “in the public health interest” and “cannot safely be accomplished.”
The Eli Lilly VP for Corporate Affairs went further:
“Therefore, we believe that the need for the physician’s supervision of any prescription drug taken by the patient is paramount and that the potential pressures of public advertising of prescription drugs on the scientific decisions of the physician are both unwise and inappropriate.”
How Television Drug Commercials Have Changed:
Now, of course, everything has changed. In 1997, the FDA modified the rules. It opened the flood gates to prescription drug advertising.
Pharmaceutical companies soon figured out that this could be a route to riches. Direct-to-consumer (DTC) advertising is also a bonanza for media companies. According to the industry monitoring publication Fierce Pharma (May 1, 2023):
“Pharma companies forked out just under $8.1 billion last year on ad campaigns…”
We suspect that this is too much money for media companies to give up.
According to Fierce Pharma, some of the most frequent television drug commercials in 2022 were for drugs such as Dupixent, Rinvoq, Entyvio, Skyrizi, Ozempic and Jardiance.
Can the FDA Put the Genie Back in the Bottle for Television Drug Commercials?
Last December the FDA issued a “final guidance” in a desperate attempt to put the genie back in the bottle. Instead of stopping the ads, though, the agency wants drug companies to present information about adverse reactions clearly and without interference from other audio or visual elements. (Just think back to the last commercial you watched. While the announcer listed side effects as rapidly as possible, weren’t people laughing and having fun?)
Here are some of the exact words from the FDA’s “Nonbinding Recommendations” for Direct-to-Consumer Prescription Drug Advertisements:
“• Standard 2 (21 CFR 202.1(e)(1)(ii)(B)): The major statement’s audio information, in terms of the volume, articulation, and pacing used, is at least as understandable as the audio information presented in the rest of the advertisement.”
“• Standard 5 (21 CFR 202.1(e)(1)(ii)(E)): During the presentation of the major statement, the advertisement does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension of the major statement.”
“To comply with this requirement, firms must ensure that their DTC [direct to consumer] TV/radio ads do not include audio or visual elements (music, sounds, text, images, etc.) during the presentation of the major statement that, alone or in combination, are likely to interfere with comprehension of the major statement.”
Although there are other important “standards” for the producers of prescription drug commercials, these stood out for us. They will also require you to do some homework.
We have observed that many television drug commercials speed through the serious side effect information while distracting visual images are presented. Here is an example of what we are talking about. Always beware of smiles! Many of the commercials we have watched show people smiling while some very scary adverse reactions are listed. You can see for yourself here.
We would love for you to determine if you have observed something similar. If so, please let us know what you have discovered and provide examples in the comment section at the bottom of this post.
Your mission, should you choose to accept it, will be to see if television drug commercials:
1) Use consumer friendly language
2) Do not speed up or change voices during the side effect section
3) Place text on the screen that is readable and stays up long enough to comprehend
4) Do not show smiling people interacting with dogs, children or friends while scary side effects are read quickly
Most People We Poll Dislike Television Drug Commercials:
It is rare these days to get a diverse group of people to agree, but in our experience, there is one topic that accomplishes that elusive goal. It is prescription drug advertising on television. Physicians, pharmacists, nurses, physician associates and patients almost all agree that they are sick and tired of such commercials. But the reasons vary.
One reader says:
“The cancer commercials upset me, as I have stage 4 cancer. I would like to relax and watch a program to try to forget about it for an hour. No chance.”
Another writes:
“I despise those drug commercials and always lunge for the mute button. Those idiotic names are insufferable! And if they truly provided ‘full disclosure,’ they’d disclose actual statistics on mortality and recovery, actual statistics on incidence of negative side effects, and the actual PRICE of the things. That would change people’s minds in a big hurry!”
This reader agrees about the price point:
“The drug ads are brazen enough to include a statement saying ‘Can’t afford your medication? XYZ drug company may be able to help.’ If you ask me, that is the most preposterous part of the ads. Why is the drug that expensive? It’s the equivalent of someone stealing your billfold, then offering to help you find it. Totally unethical, in my opinion.”
The FDA may try to put the genie back in the bottle. We fear that the Pharma genie has become far too powerful. Please help us get the genie under control by monitoring television drug commercials and reporting back what you discover in the comment section below.
We have been waging this campaign against television drug commercials for years. It has been a lonely journey. We hope you will join our efforts by sharing this post with family and friends. It’s a bit more complicated than before, though.
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