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‘A Form of Bribery’: FDA, HHS Crack Down on Misleading Drug Ads

By Michael Nevradakis, Ph.D. | The Defender | September 10, 2025

Pharmaceutical companies will be required to provide full safety disclosures in direct-to-consumer (DTC) advertisements of their products, according to a new policy HHS and the FDA announced Tuesday.

DTC advertisements “can mislead the public about the risks and benefits” and “encourage medications over lifestyle changes,” according to a memorandum by President Donald Trump outlining the policy.

The U.S. Food and Drug Administration (FDA) will send nearly 100 “enforcement action letters” and thousands of warning letters to pharmaceutical companies and drug retailers who have “increasingly been promoting drugs with no mention of side effects at all,” FDA Commissioner Marty Makary said in a post on X.

The policy also addresses online pharmacies that promote drugs with “no mention of side effects, and paid social media influencers advertising drugs,” Makary wrote.

Administration officials told ABC News that drugmakers often market their products on social media using influencers who are not clearly identified as paid spokespeople.

Mary Holland, CEO of Children’s Health Defense, called the new policy “a major victory” that will “dramatically increase the price of pharma advertising, discourage uptake because of side effects and make Big Pharma‘s lawyers stay up at night worrying that they may not have adequately disclosed risks.”

“This will greatly contribute to making America healthy again because it will start to dismantle Pharma’s grip on Big Media,” Holland said.

‘Pharmaceutical ads hooked this country on prescription drugs’

In announcing the new policy, the U.S. Department of Health and Human Services (HHS) said the ads have “distorted physician prescribing habits and patient decisions.”

The advertisements use positive emotional appeals to encourage people to get those medications, HHS said.

The new policy stops short of an outright ban on the advertising. Instead, the policy will require DTC advertisements to “report full contraindications, boxed warnings, and common precautions” — a return to regulations in effect until 1997.

HHS said the loosened regulations in place since that year created an “explosion of DTC pharmaceutical advertising,” which led to “public deception from patient confusion” and “patient harm via inappropriate demand for medications and misalignment of therapeutic choices with actual patient needs.”

Administration officials told ABC News the new policy “is the strongest, boldest action we can take to make sure that patients have adequate safety information on pharmaceutical ads.”

They said no additional steps are planned to regulate such ads.

“Pharmaceutical ads hooked this country on prescription drugs,” U.S. Health Secretary Robert F. Kennedy Jr. said in a statement. He added:

“We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising.

“Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

The new policy was announced on the same day the White House released its Make Our Children Healthy Again strategy report, which states that the federal government “will increase oversight and enforcement under current authorities for violations” of DTC drug advertising laws.

Time reported that the U.S. and New Zealand are the only countries that permit DTC drug ads. According to Digiday, Big Pharma spent $30 billion on advertising in 2024. According to HHS, drugmakers spent $369.8 million in social media advertising in 2020.

Relaxed advertising rules had ‘clear negative impact on public health’

According to the White House memo, the U.S. Congress granted the FDA authority to regulate prescription drug advertising in 1962. DTC drug advertising in the U.S. began in 1981, but regulations were loosened in 1997, resulting in a 330% increase in drug advertising by 2005.

According to HHS, the relaxed regulations permitted drugmakers to direct the public to websites, toll-free phone numbers and package inserts for details on contraindications and common precautions.

An HHS fact sheet states that this “loophole … had a clear negative impact on public health,” contributing to about 31% of the rise in U.S. drug spending since 1997.

According to HHS:

• Patients who consulted with their physician about a DTC-advertised drug were about 17 times more likely to receive a prescription than those who didn’t — the result of persuasive marketing techniques.
• 91% of direct-to-consumer drug ad claims featured social approval as a result of product use and 94% employed positive emotional appeals.
• Prescription drug use among Americans increased from 39% (1988-1994) to 49.9% (2017-2020) in the last 30 years.

Following the FDA’s loosening of its regulations in 1997, the agency’s enforcement actions also decreased. “Enforcement letters plummeted from over 130 annually in the late 1990s to just three in 2023,” according to the fact sheet.

HHS said enforcement actions will intensify, with the issuing of “dozens of enforcement letters related to false and misleading advertising, which makes the drug at issue misbranded.”

The FDA will also “send a letter to every single sponsor of an approved drug or biologic … warning them that the Agency is no longer asleep at the wheel, putting them 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.”

Drug advertising ‘a form of bribery’

Attempts by the federal government to enact a full ban on DTC drug advertisements are likely to face legal challenges, some legal experts say.

A report by The Lever in January states that it is “relatively unlikely” the federal government will be able to ban DTC pharmaceutical ads, partly because courts have previously rejected such attempts on First Amendment grounds.

Attorney Rick Jaffe wrote last year that while legal precedent exists through the 1970 ban on cigarette advertising in broadcast media in the U.S., “An advertising ban on the entire Pharma industry would be a much heavier lift.”

Despite such obstacles, the End Prescription Drugs Now Act, introduced in June and pending before Congress, would ban DTC prescription drug advertising entirely if passed.

Jeffrey Tucker, president and founder of the Brownstone Institute, said the Trump administration’s new policy is “entirely consistent with the First Amendment but will very likely make vast amounts of existing DTC advertising too arduous for it to continue as is.” He said:

“An outright ban would be easily overturned by the courts on First Amendment grounds. On the other hand, in a free society, every seller of products and services has an obligation to warn of risks. This normal practice has been neglected for a long time. This is what has allowed Pharma to spread its wings without accountability and without ensuring informed consent.

“This is an excellent step, not only to protect the public but to curb Pharma capture of the major media.”

According to CNN, the healthcare and drug industry is fourth among all industries in television advertising expenditure, accounting for 11.1% of the market. Prescription drugs accounted for 30.7% of ad minutes across evening news programs on ABC, CNN, Fox News, MSNBC and NBC last year, according to The Wall Street Journal.

According to a 2019 Forbes report, Pfizer spent twice as much on marketing its products as it did on research.

Last year, the Congressional Budget Office estimated that a 10% increase in DTC advertising results in a 1% to 2.3% increase in consumer drug spending.

Mark Crispin Miller, Ph.D., a professor of media studies at New York University whose research and teaching focus on propaganda, said such expenditures have enabled Big Pharma to exercise significant editorial control over the legacy news media.

Miller said:

“Drug advertising, like all commercial advertising, is a form of bribery that corrupts all media that carry it. This development has been the most destructive of them all. Nothing on TV, radio and/or the Internet should be ‘brought to you by Pfizer’ or any other corporate poisoner.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

September 12, 2025 - Posted by aletho | Corruption, Deception, Mainstream Media, Warmongering | FDA, United States