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Can We Stop Deceptive Drug Ads on TV?

The FDA has just issued a new "guidance" to end deceptive drug ads on TV. Warning! The recommendations are "nonbinding." Let's fight back!

Are pharmaceutical ads harming our health? Americans have adapted to seeing commercials for prescription medications on television. We take them for granted while visitors from abroad find such ads horrifying. When Meghan and Harry were interviewed by Oprah Winfrey in 2021, Britons who watched the British broadcast were shocked. Such commercials are banned in the UK and most other countries in the world. Deceptive drug ads are commonplace in the US, however, and the FDA seems powerless to make changes, even though it has just issued a new guidance on “Direct-to-Consumer Promotional Labeling Labeling and Advertisements (June 27, 2023).”

How Much Does PHARMA Spend on Advertising?

According to Fierce Pharma (May 1, 2023), an industry monitoring publication:

“Pharma companies forked out just under $8.1 billion last year on ad campaigns, according to Vivvix, with spend from 2021 being just over $8 billion, leaving things at an even keel year on year.”

Here are just a few examples:

Sanofi and Regenero spent $491 million on Dupixent, a drug for asthma and eczema (atopic dermatitis).

Surely you have seen the Rinvoq commercials from AbbVie. The company spent $425.9 million advertising this drug for conditions like rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis and Crohn’s disease. We have commented on these commercials at this link.

We could go on and on, but you get the picture. We believe many of the commercials you see are misleading because the visual images distract you from the required recitation of incredibly scary side effects including cancer and death.

Deceptive Drug Ads?

In a typical TV spot, you see someone suffering. Then after using the medication, with the brand name presented in large letters and possibly with a catchy tune, they begin to have a wonderful time. There’s music and dancing and plenty of smiles, and often cute children or dogs as well.

Meanwhile, the voiceover rattles rapidly through a long list of potential side effects. One new commercial lists heart attacks, strokes, blood clots, depression, suicidal thoughts, abnormal liver tests, bone loss and hypertension. We suspect that most people ignore such a list of horrific adverse reactions. Another possibility is that they assume such complications are rare or would not apply to them.

What’s the FDA Doing About Deceptive Drug Ads?

Now, the FDA Food and Drug Administration has released its final “guidance” on direct to consumer advertising. Instead of general statements about how wonderful a medicine is, drug companies are being encouraged to provide data about both benefits and risks.

The FDA wants companies to provide information that is truthful and not misleading. It should be precise enough and presented in ways that the public can understand so their perception of the advertised drug will be accurate. Check out the guidance for yourself at this link.

The only problem with this guidance is that it is voluntary. Every page of the document is marked with the headline:

“Contains Nonbinding Recommendations.”

Hmmm….Do you get the sense that the FDA is a “paper tiger.” Not much bark and very little bite.

How Prescription Drugs Ads Have Proliferated:

If you watch any TV, chances are good that you have seem promotions for Dupixent to treat atopic dermatitis (eczema) and asthma, Rybelsus, Ozempic, Trulicity and Jardiance for type 2 diabetes, Humira for psoriasis and severe arthritis and Rinvoq for eczema, rheumatoid arthritis and ulcerative colitis.

That just scratches the surface. There are so many drug commercials that we have lost count. Let’s not forget Skyrizi, Rexulti and Tremfya. Why are there so many prescription drug ads on television anyway?

A Walk Down Memory Lane:

Prior to 1997, prescription drug advertising on television was virtually nonexistent. Climb into our People’s Pharmacy Time Machine to the early 1980s and you would rarely, if ever, have seen direct-to-consumer (DTC) prescription drug commercials.

When Representative John Dingell from Michigan asked some of the leading executives of pharmaceutical companies if they were planning to create DTC commercials, the answer was an unequivocal NO!

The Vice President for Corporate Affairs at Eli Lilly, Edgar Davis, told the U.S. House of Representatives:

“We do not believe that commercial advertising of prescription drugs is appropriate…prescription drugs embody a complex set of factors with potential human effects that can best be evaluated by the physician…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.”

The PHARMA thought leaders all agreed that Rx advertising to consumers was a “terrible idea”! That was in 1984. You can read more about this slippery slope at this link.

Then the FDA Opened the Flood Gates:

In 1997 the FDA made it easier for Big Pharma to advertise prescription drugs to patients (American Journal of Public Health, Jan. 2010).
It did not take long for TV commercials for Rx drugs to start proliferating.

Today, they make up a sizable proportion of TV advertising dollars. The FDA is largely responsible for this avalanche. In our opinion, it has allowed deceptive drug ads to multiply like mosquitoes after a rainy spell.

What Leads to Deceptive Drug Ads on TV?

We think it is lax oversight by the FDA. That’s not just our opinion, though.

Here is what the Government Accountability Office (GAO) had to say about this in 2006:

“FDA reviews a small portion of the DTC materials it receives. To identify materials that have the greatest potential to impact public health, FDA has informal criteria to prioritize materials for review. However, FDA has not documented these criteria, does not apply them systematically to all of the materials it receives, and does not track information on its reviews. As a result, the agency cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority.”

“The effectiveness of FDA’s regulatory letters at halting the dissemination of violative DTC materials has been limited. The 19 regulatory letters FDA issued in 2004 and 2005 were issued an average of 8 months after the materials were first disseminated. By the time FDA issued these letters, companies had already discontinued use of more than half of the violative materials.”

The GAO called for more prompt FDA action:

“…in order to limit consumers’ exposure to false or misleading advertising.”

Remember Marlboro Country?

Once upon a time there were ads for cigarettes on television. For decades, the “Marlboro Man” was an icon of rugged masculinity and Marlboro cigarettes. For those of you who never saw or cannot remember “Marlboro Country” commercials, here is a link to a 1968 classic.

In 1970 Congress banned all cigarette advertisements from radio and television. The commercials disappeared early in 1971. These days, people would be shocked to see a cigarette ad on television.

Should Deceptive Drug Ads Be Banned?

Prescription drug ads, on the other hand, have proliferated. It’s hard to watch the evening news without seeing commercials for cancer treatments, medicines for psoriasis or rheumatoid arthritis or drugs for asthma and eczema.

Whenever someone suggests that such promotions should be scaled back, lawyers are quick to respond that companies have First Amendment rights of free speech. There is a perception that the Supreme Court would rule against any efforts to restrict prescription drug advertising directly to consumers.

What Are the FDA’s Rules for DTC Advertising?

Prescription drug advertising must meet certain criteria. For example, it should not be misleading (New England Journal of Medicine, May 31, 2007).

The FDA is supposed to protect us from deceptive drug ads. We don’t think the agency is doing a very good job, though.

We believe that many prescription drug ads on TV are misleading. That’s because they are designed to emphasize the potential benefits someone might experience from a drug without always providing actual data on effectiveness.

The Office of Prescription Drug Promotion (OPDP):

You are probably not aware that the FDA has people devoted to monitoring drug advertising.

Here is their mandate:

“OPDP protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. This is accomplished through comprehensive surveillance, compliance, and education programs, and by fostering better communication of labeling and promotional information to both healthcare providers and consumers.”

FDA spells out what Pharma companies must do to avoid deceptive drug ads:

“The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that all drug advertisements contain (among other things) information in brief summary relating to side effects, contraindications, and effectiveness.

“In addition to the specific disclosure requirements, advertisements cannot be false or misleading or omit material facts. They also must present a fair balance between effectiveness and risk information. FDA has consistently required that appropriate communication of effectiveness information includes any significant limitations to product use.”

I do not know about you, but I find the effectiveness data on most prescription drug ads disappointing. What you often see is someone with a pretty serious health problem having a lot of fun thanks to the medication.

Take the Latuda commercial for bipolar depression.  We see three people who look super sad. The announcer says:

“The lows of bipolar depression can take you to a dark place and be hard to manage.”

The visual images are dark and grim.

Then the visual image changes radically. We see a bright and airy space. A young man has a smile on his face and he embraces a smiling woman.

The announcer says:

“Latuda could make a real difference in your symptoms. Latuda was proven to significantly reduce bipolar depression symptoms.”

Under the happy video in smaller print we read that this benefit occurred:

“In 6-week clinical studies compared to placebo.
“Results may vary.”

That effectiveness data may satisfy the FDA, but I wish it were more detailed. I am not sure six weeks is adequate to assess long-term benefit.

Then come the side effects:

Drug companies are required to provide adverse reaction information. But commercial producers have become adept at serving up distracting visuals while a list of scary side effects is read. During the Latruda commercial we see two couples playing a board game.

They are smiling and having a great time as the announcer says:

“Latuda is not for everyone. Call your doctor about unusual mood changes, behaviors or suicidal thoughts. Antidepressants can increase these in children, teens and young adults. Elderly dementia patients on Latuda have an increased risk of death or stroke. Call your doctor about fever, stiff muscles and confusion as these may be life threatening or uncontrollable muscle movements as these may be permanent. These are not all serious side effects.”

That last sentence leaves a lot unmentioned. Other potential adverse reactions with lurasidone (Latuda) include jitteriness, agitation, anxiety, fidgeting, sleepiness, fatigue, nausea and digestive upset.

The Art of Distraction:

An ad for the breast cancer drug Verzenio (abemaciclib) shows women smiling while the announcer talks quickly about severe diarrhea, dehydration, serious infection that can lead to death and blood clots that can lead to death. That doesn’t even include common side effects such as nausea, headache, tiredness or hair loss.

Other commercials often include children or dogs during the side effect disclosures. There is also a lot of action. A Rinvoq ad features a young woman jumping out of a helicopter, a young man shadow boxing and a tattoo artist at work. Another Rinvoq commercial features exciting river rafting. With all that going on plus big smiles, it may be hard to focus on the chance that the drug could cause lymphoma and skin cancer.

Can We Overcome Deceptive Drug Ads?

Perhaps it is time for Congress to pass legislation that would regulate direct to consumer drug advertising. A bill called the Banning Misleading Drug Ads Act has been introduced by Representative Abigail Spanberger of Virginia.

Rep. Spanberger points out:

“Critical medical decisions should always be made between a patient and their doctor — not between a patient and their television screen.”

She and her colleagues believe that:

“for far too long, drug companies have used deceitful advertising tactics to distract consumers from the potentially harmful reactions to their products.”

We think this initiative is long overdue. The FDA was supposed to develop rules about avoiding distractions 15 years ago. If you think that it is time for the agency to crack down on misleading commercials, you may want to write to your Representative and urge support of this legislation. You can also contact the FDA Commissioner, Dr. Robert Califf, to tell him what you think about prescription drug ads on television.

One More Thing: Report Bad Ads!

The FDA actually has a “Bad Ad Program.” It is:

“…an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to raise awareness among healthcare providers including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees about potentially false or misleading prescription drug promotion while also providing them with an easy way to report it to the Agency.”

“To report potentially false or misleading prescription drug promotion:
• Email: BadAd@fda.gov
• Call toll-free 855-RX-BADAD or 855-792-2323
• Write:

Bad Ad Program
FDA/CDER/OPDP
5901-B Ammendale Rd
Beltsville, MD 20705-1266

Final Words:

We would like to see fewer prescription drug commercials on television. What about you? Share your thoughts in the comment section below. Would you like to see fewer smiling faces and distracting images during the mandatory listing of serious drug side effects? Please share your comments. We will pass them along to executives at the FDA. Maybe someone there will listen.

If you think this is an important message, please share it with friends and family. You know the drill. Scroll to the top of the page and click on email, Twitter or Facebook. Please spread the word that the FDA needs to crack down on deceptive drug ads. And Congress needs to pass legislation like the bill that Abigail Spanberger has submitted: Banning Misleading Drug Ads Act. Remember, the latest “guidance” from the FDA about DTC advertising contains “nonbinding recommendations.”

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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