On May 20, 2024, a new set of rules designed by the Food and Drug Administration (FDA) to improve clarity in medication advertising went into effect. The agency gave firms until Nov 20, 2024 to comply. Now that the six-month deadline has come and gone, it remains to be seen how Robert F. Kennedy (RFK) Jr., the new Secretary of Health and Human Services, will enforce these rules.
The FDA’s new rules establish guidance to ensure that TV and radio ads clearly communicate the risks and benefits of medications. They recommend measures such as keeping text on screen long enough to read, minimizing distractions from images and audio, and other strategies to help viewers fully grasp how a drug may affect them.
Still, this guidance—nearly 15 years in the making—warrants a closer look, especially given RFK Jr.’s stance that direct-to-consumer drug commercials should be eliminated entirely.
It’s also worth asking: Will it bring real change to the drug ads we’ve grown so accustomed to during commercial breaks?
According to at least one expert, the answer to that question is simple: No.
“I don’t think [the guidance] will make a meaningful difference,” says Michael DiStefano, Ph.D., an Assistant Professor in the Center for Pharmaceutical Outcomes Research at the University of Colorado, adding that most people will still learn about their medications through conversations with their healthcare providers.
New FDA Guidance: What Types of Drug Ads Are Impacted?
While there are a variety of direct-to-consumer (DTC) drug advertisements, the FDA’s new guidance specifically applies to radio and TV ads — the commercials you see on television or hear on the radio detailing the benefits of specific drugs for specific conditions. (Think people singing “Oh, Oh, Oh Ozempic!” to the tune of “Oh-Oh-Oh it’s magic!”)
The U.S. and New Zealand are the only high-income countries that allow DTC pharmaceutical advertising, which is aimed at the public rather than healthcare professionals. In the U.S., these ads became widespread in the 1980s, not because of a law allowing them, but because no law ever explicitly prohibited the practice.
These consumer-targeted ads are big business; every year, drug makers spend billions of dollars on advertising. In 2023, one analysis estimated that AbbVie—the year’s biggest spender—spent $579.7 million on advertising for just a single drug: Skyrizi, which is prescribed to treat psoriasis, Crohn’s disease, and ulcerative colitis. The drug made AbbVie $7.7 billion in sales.
While these ads may drive significant revenue, a 2023 study found that fewer than a third of the drugs most frequently advertised on television were rated as having “high therapeutic value” by independent health technology assessment agencies in Canada, France, and Germany. This suggests that, in many cases, these drugs offer little added benefit over existing — and sometimes cheaper — treatments for the same condition.
“What worries me,” says Dr. DiStefano, “is the likelihood that DTC ads increase patient requests and subsequent prescribing for drugs that contribute in some way to inefficient health care spending.”
“Keep in mind,” adds Lillie Rosenthal, D.O., a physical medicine and rehabilitation physician in New York City and a MedShadow Health and Medical Advisory Panelist, “the reason why we have an ad is to sell a product.”
The Evolution of Drug Advertising Regulations: 1962 to Today
In 1962, an amendment to the Federal Food, Drug, and Cosmetic Act mandated that all medication advertisements feature a brief statement including a summary of the drug’s effectiveness, contraindications, and side effects.
The amendment — which was also the first to force drug manufacturers to provide evidence that a drug worked before it could be brought to market — was passed after thousands of children were born with severe birth defects to mothers who had taken a medication called thalidomide to treat morning sickness during pregnancy. The drug hadn’t been approved in the U.S., because a pharmacist named Frances Oldham Kelsey pointed out that the company couldn’t provide evidence that the drug would not cause nerve damage in a person’s limbs — a suspected side effect. In the United Kingdom, however, one of the many countries that had approved thalidomide, advertisements claimed that the drug “can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.”
Although the initial amendment was designed to shield citizens from predatory practices, it fell short of creating a truly transparent playing field
After 1962, drug advertisements frequently included small text listing potential side effects, but this information was often difficult to read or placed during visually engaging moments in TV commercials to divert attention. Meanwhile, voiceovers that started at a natural, conversational pace would abruptly speed up when reciting side effects, making it harder for viewers to absorb the details.
Breaking Down the FDA’s 2024 Drug Ad Guidelines: What’s Changing Now?
The updated 2024 guidance urges companies to present medication risks as clearly as the benefits, discouraging the use of tiny text, distracting visuals, and rapid-fire voiceovers.
The guidance also focuses on aspects of a commercial that determine whether or not viewers will notice and understand the risk information, explained an FDA spokesperson in an email to MedShadow.
Some examples of the FDA’s 2024 guidance include:
- The language in DTC drug ads must be consumer-friendly and easy to understand.
- Text on a screen should match verbal audio and be left on the screen long enough to be easily read.
- The color of the text must contrast with the background image.
- Audio must be spoken at a clear volume and pace.
How Does the FDA Enforce Advertising Rules?
The FDA has a system in place to notify drug companies that fail to follow best practices for advertisements, and this process will remain in effect under the new guidelines.
If the FDA determines that a company’s advertisements violate their updated standards, it can issue one of three types of letters: an It Has Come to Our Attention (IHCTOA) letter, an Untitled letter, and a Warning letter. These notices are sent directly to the company, with some also made publicly available on the FDA’s website. Failure to comply with advertising regulations can result in a drug being classified as misbranded, which may lead to legal action, including injunctions or penalties.
IHCTOA Letters
IHCTOA letters serve as a preliminary “heads-up” from the FDA, alerting a company that its product promotion may potentially violate the Federal Food, Drug, and Cosmetic Act. IHCTOA letters are not currently published publicly online, but they can be accessed through freedom of information act (FOIA) requests.
“These letters are not intended to communicate that FDA is considering enforcement action,” according to the FDA website.
Untitled Letters
An Untitled letter cites confirmed ad violations and invites the company to update its ads to comply with the FDA’s guidance — but does not threaten any sort of enforcement action. Some of these letters are made publicly available on the FDA’s website, but their publication is at the agency’s discretion.
These types of letters typically include a request—but not a requirement—that the company responds within a specific period of time such as 15-30 working days. That response can include an argument as to why the ad or ads should not be changed, or a plan of action for how and when they will be updated.
Warning Letters
A Warning letter is the most serious type of letter the FDA can send. It details violations and allows companies to respond and correct their violations within 15 days (or explain why it’ll take longer than that), before the agency takes enforcement actions, such as seizing supplies of the drug or taking the company to court.
The FDA’s newly tightened 2024 guidance could present fresh hurdles for pharmaceutical companies, but the agency has remained silent on whether this marks the beginning of a broader crackdown on drug advertising. Officials have declined to say whether enforcement will go beyond issuing advisory letters—recommendations that, for now, carry no direct consequences for companies that choose to ignore them.
And despite his outspoken criticism of direct-to-consumer drug advertising, RFK Jr. is unlikely to succeed in banning it outright, notes DiStefano. However, he could still shape its future in other ways—particularly by influencing how much funding the FDA allocates to regulating these ads. Increased resources could lead to more thorough and timely oversight, while budget cuts might leave companies with little incentive to follow the rules, knowing enforcement is minimal.
How to Watch Drug Commercials with a Critical Eye
Direct-to-consumer drug commercials do more than just promote relief for a medical condition—they also send messages about happiness, socializing, and overall well-being, notes Dr. Rosenthal. She encourages viewers to consider whether those benefits can be achieved in other ways before turning to medication. “Medications can help people,” continues Dr. Rosenthal, “but we still need to think critically about them.”
There should always be an open dialogue between you and your doctor when you are prescribed a new medication. Some questions Dr. Rosenthal recommends people ask include:
- What are the side effects of this drug?
- Is there any reason why I shouldn’t be taking this?
- Are there other things I could do, without causing side effects, that might help me feel better?
As much as Dr. Rosenthal would love to see more “public health commercials” — advertisements promoting lifestyle changes — “no one makes money advertising taking a walk.”
