Written by: Pharmacally Medical News Desk
Direct-to-consumer drug advertising in the United States has become a major public health problem. In a recent JAMA commentary (September 2025), FDA Commissioner Dr. Martin A. Makary called these ads misleading and harmful. He said the FDA will take firm action to stop dishonest marketing and protect patients.
The Problem
The United States and New Zealand are the only countries that allow direct drug advertising to the public. The FDA relaxed rules in 1997, and drug companies quickly took advantage. Within ten years, ad spending grew by almost 800%. Most ads highlighted benefits while downplaying serious risks.
Makary explained that companies design commercials to distract people. They show happy families and polished scenes with patients laughing, singing and dancing and active lifestyles while racing through fine print warnings about seizures, addiction, or even death. He said this strategy creates a false impression and pressures patients to demand drugs they may not need.
FDA oversight collapsed over time. In the late 1990s, the agency sent hundreds of enforcement letters each year to violators. By 2023, it sent only one. In 2024, it sent none. Makary said this failure weakened trust between doctors and patients and increased unnecessary prescribing.
The Impact
Studies showed that direct drug advertising pushes both spending and poor medical choices. A 2023 study found that advertising stimulated 31% of the growth in U.S. drug spending since 1997. Companies spent more on drugs with low clinical benefit, not on those that offered real advances.
This pressure often pushes doctors to prescribe drugs that patients request even when the drugs are not the best choice. A 2021 review showed that advertising increases prescription requests, raises the chance doctors will give in, and leads to inappropriate use.
FDA’s New Actions
Makary announced strong steps to fix the problem
Reviving Enforcement
The FDA already sent about 100 cease-and-desist letters to stop the worst ads.
It also issued thousands of warning letters to companies that broke rules.
Closing the “Adequate Provision” Loophole
Since 1997, companies used vague “major risk statements” and pointed viewers to websites for details.
The FDA will now require ads to show risks and benefits clearly and equally.
Policing Social Media and Influencers
Many drug ads on TikTok, Instagram, and other platforms show benefits but not harms.
A 2024 review found that while all posts praised drugs, only one-third mentioned risks.
The FDA will tighten control over influencer-driven ads that blur entertainment and promotion.
Cracking Down on Online Pharmacies
Telehealth companies and online sellers often advertise only benefits.
For example, a recent Super Bowl ad promoted weight-loss drugs with no risk warnings.
The FDA will step up enforcement in this space.
Free Speech and Public Health
Makary said the FDA will not ban all drug ads, since the First Amendment protects free speech. But he stressed that misleading and deceptive ads have no protection. The agency will enforce fair balance rules, close loopholes, and demand honest communication.
Stronger Enforcement and New Tools
Along with Makary’s commentary, the FDA also explained how the agency will act. The FDA and HHS will use AI tools to track deceptive ads across television, print, and social media. The agency has already sent about 100 cease-and-desist letters and thousands of warning letters. Officials also pointed out that many ads hide risks in text or sound that older adults cannot catch. The release gave new data showing that 88% of social media drug ads fail to meet fair balance rules and that almost all influencer posts highlight benefits while ignoring harms. HHS Secretary Robert F. Kennedy Jr. called for “radical transparency” and warned that deceptive ads push the country toward over medicalization.
Makary ended with a clear message “The regulatory neglect of the past 25 years ends now. Americans deserve better than a system in which pharmaceutical companies exploit loopholes while patients are misled and health care costs escalate.”
Experts seem broadly in favor of Makary’s diagnosis of the problem. Many support stronger rules, more enforcement, and greater transparency. They see this as necessary to protect patients, reduce misleading claims, and improve trust.
If the FDA follows through, this will mark the biggest shift in U.S. drug advertising since 1997. Patients will see clearer information, doctors will feel less pressure, and healthcare may finally move away from marketing-driven decisions.
References
Makary MA. The FDA’s Overdue Crackdown on Misleading Pharmaceutical Advertisements. JAMA. Published online September 12, 2025. doi:10.1001/jama.2025.18197
FDA Launches Crackdown on Deceptive Drug Advertising, 09 Sep 2025, USFDA, https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising