FDA cracks down on drugs ads, promises to end adequate provision ‘loophole’

Editor’s note: This article was updated on 12 September 2025 to correct a mischaracterization of the history of adequate provision concept in drug advertising, Regulatory Focus regrets the error.

The US Food and Drug Administration (FDA) on Tuesday announced plans to ramp up enforcement against “misleading” prescription drug advertisements and to end a longstanding regulation that allows drug companies to provide a major risk statement in ads and point the audience to more complete risk information contained elsewhere.

FDA and the Department of Health and Human Services (HHS) announced that FDA would initiate rulemaking to eliminate what they called the adequate provision "loophole." The agency asserts that adequate provision has been used to hide critical safety risks in both broadcast and digital advertisements, leading to inappropriate drug use and undermining public trust. A legal expert mentioned to Focus that this initiative overlooks the fact that there are already existing FDA rules regarding fair and balanced advertising.

In the 1960s, FDA issued regulations establishing adequate provision in drug advertisements as a means of directing viewers to the complete labeling in conjunction with a major statement detailing the product’s most important risks; however, it was not clear how the concept of adequate provision applied to broadcast advertisements until FDA issued guidance on the matter in the late 1990s.

The guidance was key to the proliferation of prescription drug advertising on television and other broadcast formats, as it would otherwise take too long or take up too much space to fully list a product’s major risks and contraindications.
  
According to a joint FDA and HHS announcement, “the proliferation of simplistic pharmaceutical ads on television and digital media distorted physician prescribing habits and patient decisions.”
 
The announcement was backed by a presidential memorandum from President Donald J. Trump, and came on the heels of the Make America Healthy Again Strategy Report, which called on federal agencies to increase oversight of DTC drug advertising.
 
FDA’s announcement cites a 2024 review in the Journal of Pharmaceutical Health Services Research, which found that while 100% of pharmaceutical social media posts highlight drug benefits, only 33% mention potential harms.
 
Speaking to News Nation on Tuesday, Makary stated that prescription drug advertising in the US has spiraled out of control.
 
“There was one analysis that showed you’re watching more pharmaceutical ads than you are football plays when you watch a football game, in some instances,” Makary said, adding that, “We as physicians don’t like the nonstop barrage of ads that create a false and misleading impression. They’re increasing demand for medications in a culture where we’ve got a pill popping society mindset.”
 
Makary also highlighted the years long trend of declining enforcement actions by FDA’s Office of Prescription Drug Promotion (OPDP). “In the last administration, in 2023, there was only one enforcement letter sent by the FDA, and last year it was zero,” Makary said, referring to warning letters sent by OPDP. In both years, OPDP sent several untitled letters to drugmakers concerning promotional activities.
 
In response, Makary said FDA has sent 108 cease-and-desist letters to drugmakers in addition to “thousands of letters warning pharmaceutical companies to remove misleading ads.” However, FDA has not provided any additional details about the cease-and-desist letters, and it is unclear what companies or advertisements they target. According to an HHS fact sheet, “FDA will send a letter to every single sponsor of an approved drug or biologic (several thousand companies) 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.”
 
In a recent statement, HHS Secretary Robert Kennedy Jr. said that “Pharmaceutical ads hooked this country on prescription drugs. “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.”
 
Dara Katcher Levy, an attorney with Hyman Phelps and McNamara, said that the latest action obscures the fact that companies have already implemented new safety information about their products in response to recent rulemaking.
 
In November 2023, FDA published a final rule changing how companies must present safety information in a “major statement” in DTC TV and radio advertising; the rule implements Food and Drug Administration Amendments Act (FDAAA) requirement in effect since March 2008 and establishes five standards for conveying a DTC ad major statement in a “clear, conspicuous and neutral manner.” (RELATED: FDA issues new standards for DTC prescription drug ads, Regulatory Focus 21 November 2023).
 
Levy said that “I think there has been a conflation between the major statement which provides fair balance and the adequate provision requirement which is supposed to provide either the prescribing information or a brief summary of the prescribing information. The adequate provision requirement is not the same as providing fair balance.”
 
“I think the major statement has served to provide fair balance in DTC commercials for prescription drugs,” Levy said, adding that, “If you watch an advertisement for a prescription drug, often times the safety information may be more than half of that commercial.”
 
Levy said that this action could be a “step short of an outright ban that in practice could result in litigation” over infringing on First Amendment grounds. She added that whether this happens depends on what a proposed rulemaking looks like.
 
The Pharmaceutical Research and Manufacturers of America (PhRMA) said that this action will make it difficult for patients to access information about a drug.
 
Alex Schriver, SVP of public affairs at PhRMA said that “PhRMA member companies are committed to responsible advertising and look forward to weighing in on the FDA’s planned rulemaking. This move by the FDA will make it harder for patients to access valuable information they need to have meaningful conversations with their doctors. Direct-to-consumer (DTC) advertising on prescription medicines provides factual and research-backed information that helps patients make informed decisions about their health care and treatment options. Truthful and non-misleading DTC advertising is protected under the First Amendment and has documented evidence of advancing patient awareness and engagement.”
 
FDA announcement