Sick of Prescription Drug Ads? FULL WARNINGS Could Curtail Commercials!

Based on informal polling, most of our readers hate prescription drug ads! We often discover that many health professionals, including physicians, pharmacists and nurses, also despise drug commercials on TV. About the only folks who seem to love them are drug and media companies that are making big bucks off these ads. Has the Food and Drug Administration figured out a way to reform pharmaceutical ads? An announcement from the FDA and HHS (Health and Human Services) on September 9, 2025, suggests that we could be in for some critical changes. We are excited. Could this be the beginning of the end for Pharma commercials?

Taking on Big Pharma’s Billion-Dollar Ad Machine:

We have been urging the FDA to crack down on misleading prescription drug ads for years. Here are just a couple of our more inflammatory articles:

“Can We Stop Deceptive Drug Ads on TV?“

“People Are Having Too Much Fun on Drug Commercials!“

“Getting Television Drug Commercials Under Control!“

Before we break out the champagne and confetti and celebrate the end of prescription drug commercials, here are warnings. On June 12, 2025, Senators Bernie Sanders and Angus King introduced  the “End Prescription Drug Ads Now Act.” It would prohibit direct-to-consumer prescription drug advertising by pharmaceutical companies.

We love the idea of ending prescription drug advertising directly to consumers, but the pharmaceutical industry has been spending billions on those ads. Drug companies can afford the priciest lawyers and lobbyists to challenge any effort to curtail commercials.

How Big Pharma and Media Companies Will Fight To Keep Prescription Drug Ads:

The pharmaceutical industry spends a ton of money on drug ads. This should come as no surprise to anyone who watches TV or streams videos on an electronic device.

Commercials for Skyrizi, Rinvoq, Dupixent, Farxiga, Wegovy and Jardiance are just a few of the brands you have probably seen advertised. Some pharmaceutical commercials appear so often that drug companies have decided all they need to do is mention the name of the product. These “reminder ads” do not tell you what the drug is prescribed for or warn about adverse reactions. The assumption is that you have already seen so many commercials that all they need to do is remind you of the name to reinforce brand recognition.

How much do drug companies spend on prescription drug ads? That number is hard to determine accurately.

A Bloomberg report (June 17, 2025) states:

“Companies spent $10.8 billion in 2024 on direct-to-consumer pharmaceutical advertising in total, according to a report from the advertising data firm MediaRadar.”

And that may be a conservative number. We have seen other estimates that put spending closer to $14 billion.

A lot of people benefit from those commercials. There are the advertising companies that make a bundle creating the commercials. Then there are the media organizations that control television and online advertising. An enormous amount of their ad revenue now comes from Big Pharma.

Let’s not forget the pharmaceutical industry! It does not throw away money needlessly. Their return on investment is impressive. Some analysts estimate that for every dollar that is spent on such advertising some companies could make as much as $5.

One of our favorite publications is the insider newsletter “Fierce Pharma.” This comes from a Fierce Pharma article by Kevin Dunleavy, June 13, 2025 titled “Sanders, King propose legislation to ban direct-to-concumer [DTC] ads for prescription drugs.”

Dunleavy wrote:

“Shortly after the election in November, research firm Intron Health identified a ban on drug advertising as ‘the biggest imminent threat from RFK and the new Trump administration.’

“The analysts noted that the return on investment for DTC drug ads is significant—with ‘estimates ranging as high as 100%-500%, depending on the drug.’ Intron added that pharmas would ‘almost certainly’ see their drug sales take a hit from a DTC ban, even as they save money on marketing spending.”

What Will the New “Full Safety Disclosures” Mean for Prescription Drug Ads?

Lawyers for the FDA and HHS knew that any attempt to ban prescription drug commercials outright would be met with a blizzard of legal challenges claiming First Amendment free speech rights. The September 9, 2025, announcement from HHS and FDA avoids that issue by focusing on “Full Safety Disclosures in Drug Ads“. That is not a First Amendment matter and it does fall under FDA’s responsibilities.

Here is how the feds introduce their new rules:

The proliferation of simplistic pharmaceutical ads on television and digital media distorted physician prescribing habits and patient decisions. Research during this time found that:

• Direct-to-consumer advertising drove about 31% of the rise in U.S. drug spending [PDF] since 1997, when the FDA relaxed ad restrictions.
• Patients who asked physicians for a direct-to-consumer advertised drug were about 17 times more likely to receive a prescription than those who didn’t.
• Seeing statin ads even briefly made low-risk patients 16% to 22% more likely to start taking the drugs.
• 91% of direct-to-consumer drug ad claims featured social approval as a result of product use and 94% employed positive emotional appeals.

The new FDA Commissioner, Marty Makary, M.D., M.P.H. stated:

“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness. Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”

Amen Dr. Makary!

The Implications of FDA’s “Reform” of Direct-to-Consumer (DTC) Advertising:

The creative lawyers and regulators at the FDA and HHS came up with an intriguing strategy to make DTC pharmaceutical advertising unpalatable for drug companies and media conglomerates.

First, the feds cited a 1997 “loophole” that allowed drug companies to:

“…run direct-to-consumer (DTC) advertisements without fully disclosing information on side effects or patient harm. The explosion of DTC pharmaceutical advertising following 1997 has led to (1) public deception from patient confusion, (2) patient harm via inappropriate demand for medications and misalignment of therapeutic choices with actual patient needs, and (3) harm to the public finances via misallocation of healthcare resources, including government spending.”

The Goal Is to Remove the 1997 Loophole!

Going forward the FDA will not allow drug company ads to “hide safety information by placing it in another format or location.”

I am getting the strong sense that drug companies will have to present far more information about drug warnings.

By turning the clock back to before the loophole, the old/new “action” requires:

“…the presentation of factual and uncontroversial statements which are already legally required to be communicated in drug advertising; goes directly to the core government interests of protecting the public from deception and protecting public health—as supported by voluminous evidence of public harm under the current system; and does not unduly burden advertisers, by preserving their right to engage in commercial speech under the standards that existed prior to 1997.”

That’s a bit legalistic. My suspicion is that the feds will require so much safety information during commercials that no drug company or television show would want to air such ads. And no viewer would want to watch them, especially if the commercial could no longer show distracting images of people having fun.

The FDA Is Warning About “Aggressive Enforcement” of DTC Violations!

The agency says it is “no longer asleep at the wheel.”

It will put drug companies on notice:

“…that FDA will be actively enforcing violations of the law, and directing them to remove all non-compliant promotional materials from the market.”

Bingo! The Food and Drug Administration has thrown down the gauntlet. If drug companies try to sidestep the new “full safety disclosures,” the FDA will be coming after them!

This seems to me to be a brilliant strategy. The feds are not restricting any First Amendment free speech rights. The regulators are just reasserting their old authority to require a lot of safety information. So much, in fact, that most drug companies and media outlets would be overwhelmed by how long the commercials would have to be and how much they would cost to air.

Doctors Are Also Fed Up with Prescription Drug Ads!

You and I are not the only ones who are fed up with prescription drug ads on television. A research letter in JAMA Network Open (Jan. 13, 2023) reveals that some very thoughtful health professionals are also concerned about prescription drug advertising.  One of the authors is Aaron S. Kesselheim, MPH, MD, JD. He is also a Professor of Medicine at Harvard Medical School. Dr. Kesselheim is an expert on pharmaceutical policy, generic drugs, FDA regulations and bioethics.

In this article Dr. Kesselheim and his colleagues point out that direct-to-consumer (DTC) drug advertising quintupled over the last two decades. You have seen the commercials where almost everyone seems to be in good health and having a great time.

Not infrequently there’s a dog or a child in the scene. Almost always there are visually compelling images, especially when it comes to the long list of scary side effects. Even as the announcer lists serious adverse reactions such as heart attacks, strokes or cancer, the actors are smiling, dancing or jumping for joy. Drug companies and their advertising agencies have perfected the art of distraction.

The New Research Punctures the Balloon:

Research in JAMA Network Open describes how the drug companies justify these commercials.

Here’s why the authors undertook this research project:

“Proponents have argued that such advertising improves public health by promoting clinically beneficial prescribing. We assessed the therapeutic value (ie, whether they represent advances over existing treatments) of drugs subject to most direct-to-consumer television advertising from 2015 to 2021.”

These investigators wanted to know whether the drugs being advertised the most were really valuable therapeutic agents. Here are their conclusions:

“Fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared with existing therapies. Manufacturers’ television advertising spending on included products rated as low therapeutic value was $15.9 billion from 2015 to 2021.”

Why would drug companies spend so much money advertising prescription drug that were not of extraordinary value? The authors answer:

“One explanation might be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have greater incentive to promote drugs of lesser value.”

The Spread of Prescription Drug Ads:

Prescription drug ads pay for a lot of your television viewing. If you have the impression that there are more such commercials on TV than there used to be, you are correct.

A study published in JAMA (Jan. 8, 2019) found that direct-to-consumer advertising went from $2.1 billion in 1997 to $9.6 billion in 2016. The proportion of marketing dollars spent on reaching consumers also increased during the last two decades. It went from 11.9% of total marketing dollars in 1997 to 32% of the total in 2016.

The U.S. Government Accountability Office (GAO) reported in May, 2021 that:

“Drug manufacturers spent $17.8 billion on direct-to-consumer advertising (DTCA) for 553 drugs from 2016 through 2018, and spending was relatively stable at about $6 billion each year. Almost half of this spending was for three therapeutic categories of drugs that treat chronic medical conditions, such as arthritis, diabetes, and depression. GAO also found that nearly all DTCA spending was on brand-name drugs, with about two-thirds concentrated on 39 drugs, about half of which entered the market from 2014 through 2017.”

A Brief History of Prescription Drug Ads:

You may wonder how we reached this point. In 1983, then-FDA commissioner Arthur Hayes asked drug companies if they were planning to push for prescription drug ads directed at patients.

According to an article by Dylan Scott (Stat, Dec. 11, 2016):

“Almost all of them said, ‘No, that would be a terrible idea.’”

In 1984 drug companies responded to Representative John Dingell from Michigan about DTC drug advertising:

R.T. Parfet, Chairman of the Board, Upjohn Company, (U.S. House of Representatives, 1984):

“The view of the Upjohn Company is that the direct advertising of prescription pharmaceuticals to consumers…would be detrimental to the pharmaceutical industry and, more importantly, a potentially disruptive element in our medical delivery system as a whole…Our view is that there is a vast difference between education and promotion…Product specific consumer ads could increase costs.”

Allan S. Kushen, Senior Vice President, Public Affairs, Schering-Plough (U.S. House of Representatives, 1984):

“We have serious concerns about proposals to allow advertising directly to patients. We do not believe it is in the public health interest; indeed we believe that, in most cases, it cannot safely be accomplished.”

Edgar G. Davis, Vice President, Corporate Affairs, Eli Lilly and Company (U.S. House of Representatives, 1984):

“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.”

An About-Face About Prescription Drug Ads:

Then in 1997, for reasons that remain mysterious to us, the FDA decided to make it easier for drug companies to advertise prescription drugs directly to consumers. The companies conveniently forgot their concerns about such practices. The floodgates opened.

The special communication in JAMA (Jan. 8, 2019) by Drs. Schwartz and Woloshin noted the change from 1997 to 2016:

“DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies.”

Can you believe it? In 2016 there were 663,000 TV commercials for prescription drug ads! We bet there were a lot more than that last year.

Our Readers Despise Prescription Drug Ads!

Most of our readers really dislike prescription drug advertising on television. As far as we can tell, only two countries in the world permit this kind of direct to consumer drug promotion. Here are just a few comments.

Heide wrote:

“Frankly, I HATE TV ads for drugs. I don’t believe they should be advertised. Isn’t my doctor smart enough to know what to prescribe?”

Nancy added:

“I have watched the drug commercials during the evening news breaks. Everyone is smiling and doing some kind of (usually pleasurable) activity. No one in the ads looks the least bit sick; all are full of happiness and health! It is criminal that these kinds of misleading and dangerous ads are allowed to proliferate. Their only purpose is to pile up profits.”

Cindy offered her opinion:

“I honestly do not believe that drug companies should be allowed to advertise. Some shows only seem to have commercials from drug companies.

“I had a serious allergic reaction to an arthritis drug. I reached out to the company and received no response.”

Carol’s experience and thus her perspective are distinct:

“I worked for a major pharmaceutical company for 27 years in the research and development area. I believe they do many good things for the world. They are the only companies with the facilities, money, and research brain power that can provide the medicines we all need at some time in our lives.

“This said, I do not believe big pharma should be allowed to advertise their products on television or in print. Advertising these products does more harm than good. Allow doctors to decide what is good for their patients.”

Why Didn’t the FDA Crack Down Earlier on Prescription Drug Ads?

Where has the FDA been when it comes to monitoring prescription drug commercials? Why did the agency warn physicians about really serious adverse drug reactions with one hand and allow these DTC commercials to proliferate with the other? Here is an example that has blown our minds.

The Rinvoq Challenge!

On January 14, 2022 the FDA issued an update on some very serious warnings for a category of drugs called Janus Kinase (JAK) inhibitors. The drugs in question include baricitinib (Olumiant), upadacitinib (Rinvoq) and tofacitinib (Xeljanz):

“We are requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.”

The “Boxed Warning” is the FDA’s way of saying watch out (National Library of Medicine, Sept. 19, 2021):

“Boxed warnings (formerly known as Black Box Warnings) are the highest safety-related warning that medications can have assigned by the Food and Drug Administration. These warnings are intended to bring the consumer’s attention to the major risks of the drug.”

Here is a link to the BOXED WARNING for Rinvoq: The headline:

“WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS”

I won’t bore you with the long and complex boxed warning for Rinvoq. It discusses serious infections like tuberculosis and “invasive fungal infections” along with “bacterial, viral, herpes zoster, and other infections due to opportunistic pathogens.”

Then there are the “major adverse cardiovascular events” aka MACE. They are “defined as cardiovascular death, myocardial infarction [heart attack], and stroke.”

One of the Prescription Drug Ads for Rinvoq:

A commercial for Rinvoq promotes this drug for treating eczema (atopic dermatitis). This condition often causes redness, itching or rash. While it is certainly unpleasant, eczema is not a life-threatening condition.

The Rinvoq commercial features very active young adults. One is climbing into a helicopter, while another works out in a gym. In addition, we see a DJ spinning records and a tattoo artist at work.

Then we hear about the side effects:

“Rinvoq can lower your ability to fight infections including TB. Serious infections or blood clots, some fatal, cancers, including lymphoma and skin cancer, death, heart attack, stroke and tears in the stomach or intestines occurred. People 50 and older with at least one risk factor for heart disease have higher risks. Don’t take if allergic to Rinvoq, as serious reactions can occur.”

We have always wondered how someone would know that they were allergic to a drug like Rinvoq before they started taking it.

The visual images during the announcements about adverse effects are arresting. A man hits a punching bag and shadow boxes. A woman jumps out of a helicopter and starts running. The DJ adjusts her volume while moving to the music and the tattoo artist shows off the finished design. Check out the commercial for yourself at this link.

Big Bucks Being Spent on Rinvoq Commercials!

Rinvoq is not just for eczema. The FDA has given this JAK inhibitor a green light for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis (eczema), and ankylosing spondylitis. Fierce Pharma monitors the pharmaceutical industry. It provides news and analysis about drug companies. An article on July 8, 2022 about drug marketing was titled:

“Dupixent dethroned as AbbVie rival Rinvoq shoots to the top of pharma’s TV ad spenders.”

The bottom line seems to be that Rinvoq is high on the list when it comes to prescription drug ads:

“AbbVie spent $26.3 million on TV ads for the arthritis and psoriasis med last month, more than double the $12.9 million it spent the month prior.

“Most of that spend ($15.1 million) went to its new TV ad “Helicopter”, which went live on May 31 and is the first commercial for its new eczema approval, which should be a big money spinner for the drug.”

So, even with a boxed warning, Rinvoq is expected to be a “big money spinner.” Check out the “Helicopter” ad to promote the treatment of eczema at this link.

We were already concerned about older Rinvoq commercials. You can read my take on the way the drug is being promoted for rheumatoid arthritis at this link.

Where Was the FDA?

We asked the FDA if it approved such commercials before they aired.

The answer:

“No, FDA does not approve the wording and/or visual presentation of every DTC [direct to consumer] prescription drug advertisement.”

The FDA added this:

“Please also note that the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that all prescription 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.”

We applaud the idea of communicating effectiveness information. Sadly, though, relatively few prescription drug ads actually tell viewers how likely they are to get meaningful benefit. We call this “absolute risk reduction.” Our favorite example involves the cholesterol-lowering drug Lipitor (atorvastatin). Here is a link to one commercial for this popular drug.

There is nothing in the commercial about actual effectiveness. The print ads are a bit more revealing, however. The company boasted that Lipitor lowered the risk of heart attacks by 36 percent. On the surface, that seems quite impressive. Many people might think that if they took Lipitor they could reduce their chances of developing a heart attack by more than one third over five years. But there was an asterisk next to the 36 percent.

If someone took the time to look for the asterisk and the smaller print they would discover:

“That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”

The absolute risk reduction after several years on Lipitor was 1%. You did not see that effectiveness data in the TV commercial!

Do DTC Prescription Drug Ads Work?

There is little question that these commercials are effective. Drug companies would not spend billions of dollars if they weren’t getting a substantial return on their investment.

One of the co-authors of the JAMA study, Dr. Steve Woloshin, told Kaiser Health News:

“Marketing drives more testing. It drives more treatments. It’s a big part of why health care is so expensive, because it’s the fancy, high-tech things that get marketed.”

We Complained to the FDA!

For many years, we have been a cracked record complaining about prescription drug ads. There is a “formula” that drug companies use to distract people from the part of the commercial that talks about nasty side effects. In virtually every ad you will see people smiling and having a good time when the announcer starts listing horrific drug side effects. Here is an article we wrote about this:

Do NOT Trust People Smiling During Drug Commercials

We complained about this practice to the FDA’s Office of Prescription Drug Promotion.

Here’s what came back in response:

“Thank you for taking the time to alert us to potentially misleading promotion.  You and other healthcare providers are some of the most important resources we have in monitoring promotional activities in the prescription drug market.  Below is a detailed explanation of how we will use the information you have provided to help stop misleading promotion.

“If you provided contact information in your complaint, an Office of Prescription Drug Promotion (OPDP) representative may contact you to see if you would like to discuss your complaint.”

What that means is that consumers should view such commercials cautiously. Close your eyes when the side effects are listed so you won’t be distracted by the action.

Are You Fed Up Yet?

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