HPM Fact Sheet: Ensuring FDA and HHS Are Held Accountable For “Radical Transparency” and Communicating Truthful and Non-Misleading Information About DTC Rx Drug Ad “Crackdown”

Note:  This HPM Fact Sheet, like HHS’s recently issued Fact Sheet, is intended to bring some radical transparency to the discussion around the recently announced DTC Rx drug ad “crackdown.”  These bloggers thought it would be helpful to clarify some issues.

On September 9, 2025, President Trump, HHS, and FDA issued coordinated statements regarding a “crackdown” on DTC Rx drug ads.  HHS and FDA have repeatedly and inaccurately referred to a “loophole” established in 1997 that allows pharmaceutical companies to “withhold vital safety information in advertisements.”  This narrative is patently false and is designed to justify rulemaking and enforcement activity to effectively shut down pharmaceutical companies from communicating with consumers.

FDA is taking action to effectively ban DTC broadcast advertising by engaging in rule-making to purportedly close a “loophole” that doesn’t exist.  Adequate provision enables pharmaceutical companies to direct patients to where they can obtain a drug’s full prescribing information or the brief summary of the full prescribing information.  Neither the full prescribing information nor the brief summary are intended to meet FDA’s “fair balance” requirement pertaining to providing risk information to balance benefit information.  FDA’s suggested action is intended to ensure the length of a DTC broadcast ad is increased with non-essential information – not in an effort to improve the quality and comprehensibility of information provided to consumers – but to dissuade pharmaceutical companies from continuing to disseminate DTC broadcast ads. 

What the FDA is Doing

1. Scapegoating the 1997 Adequate Provision “Loophole” by ignoring “fair balance” requirements.
2. Issuing “cease and desist” letters, in Untitled Letter and Warning Letter formats, that appear to be based on AI surveillance and may be AI generated.
3. Pretending that thoughtful regulatory oversight previously did not encompass TV and social media promotional activities when FDA has routinely monitored TV and social media posts for violative behavior for years.
4. Ignoring final rulemaking, implemented in November 2024, that sought to improve the quality, content and delivery of the major statement of a drug’s risks in broadcast ads.

Detail on this Action

•  Adequate Provision “Loophole:”
  • The FDA is initiating a rulemaking process to purportedly eliminate a loophole that doesn’t exist.  Broadcast ads must include fair balance, which is accomplished by the “major statement.”  “Adequate Provision” allows an ad to be “accompanied” by the prescribing information or brief summary by instructing a viewer on how they can obtain that information.
  • FDA mischaracterizes adequate provision as a “loophole” and ignores that the legal standards for fair balance and risk disclosure are well‑established and already enforceable.
  • FDA’s existing framework already requires that broadcast ads include a major statement of key risks and provide adequate provision (e.g., a website) to access full prescribing information.
  • Fair balance requires ads to provide information about drug risks as compared to drug benefits. This means that the content and presentation of a drug’s most important risks must be reasonably similar to the content and presentation of its benefits.
    • In fact, most broadcast ads spend more time describing a drug’s risks than its benefits.
  • FDA references in media interviews about this initiative to videos and ads that contain “no risk information” are likely not those sponsored by pharmaceutical companies that are generally well aware of regulatory requirements.
  • The “adequate provision” policy does not limit “informed patient consent” (where does this term even come from?).

• While HHS frames these reforms as a consumer‑protection measure, they align with the Secretary of HHS’s long‑standing opposition to DTC drug advertising. The intent is not to improve the quality of drug ads but to create a de facto ban on DTC ads by making compliance prohibitively complex.

• Additional Enforcement Action:
  • A general industry letter was sent to all application holders alerting them of FDA’s increased vigilance over DTC ads.  This letter does not appear to have any legal consequence (unlike FTC notices of noncompliance which are required by their civil penalty authority).  This was likely a performative gesture.
  • The FDA has begun issuing Warning and Untitled Letters, referred to in its press release as “cease and desist” letters.
  • From what we have seen, these Warning and Untitled Letters are not signed by the Office of Prescription Drug Promotion.  Instead, both Untitled and Warning Letters that we have become aware of are signed by George Tidmarsh, Director of CDER.
  • From the “cease-and-desist” letters we’ve become aware of, not all deal with DTC broadcast ads or social media and not all deal with issues pertaining to risk information.  We suspect that many of these letters may have been AI generated based on AI surveillance and may include errors.
  • It is unclear whether any Warning Letters issued were reviewed by the Office of Chief Counsel.
  • FDA has stated it intends to increase scrutiny of DTC advertising and has threatened to “return to the 1990s paradigm of issuing hundreds of enforcement letters each year.”
  • FDA supposedly is closing “digital loopholes” to encompass all social media promotional activity, notwithstanding FDA and FTC monitoring of this space for decades.

FDA claims that the lack of appropriate patient safety information in DTC pharmaceutical ads has directly led to negative health and economic impacts.

• This administration fired the OPDP social scientists researching pharmaceutical advertising impacts on consumers, belying the Administration’s concerns about health and economic impacts.

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