Getting to the Facts on the Presidential Memorandum

On Tuesday, September 9th, 2025, President Trump issued a report and presidential memorandum that seeks to “ensure that the current regulatory framework for drug advertising results in fair, balanced, and complete information for American consumers.” This echoes messaging Secretary Robert F. Kennedy has been publicly reinforcing over the past several weeks to provide greater scrutiny on direct to consumer (“DTC”) pharmaceutical ads. The directive focuses on “transparency and accuracy in direct-to-consumer prescription drug advertisements,” with particular emphasis on “increasing the amount of information regarding any risks associated with the use of prescription drugs.” 

What’s Already in Place

These core principles cited by President Trump are not new. They have been part of the law for nearly three decades, codified in Section 502 of the Federal Food, Drug & Cosmetics Act, and various amendments. Most recently, in 2023, the FDA introduced the “clear, conspicuous, and neutral” (“CCN”) guidelines, which simplified the standard for direct-to-consumer ads for TV and radio. Under these guidelines, TV and radio ads already must “state the name of the drug and its conditions of use . . . [and] present the major statement relating to side effects and contraindications (“major statement”) in a clear, conspicuous, and neutral manner.”

What This Means and What it Doesn’t

Despite the headlines, this is not a ban on DTC pharmaceutical advertising. Instead, it targets the messaging within the ads by reinforcing the FDA’s existing requirements to ensure ads are both accurate and transparent. It also signals plans to further enforce these guidelines. Both of these intentions will be met with legal and procedural challenges as outlined below.

As Jim Potter, Executive Director of the Coalition for Healthcare Communications, the leading advocacy agency for health-based advertising recently stated, “Misleading DTC Rx advertising is the cornerstone of FDA law and regulations, which the healthcare marketing industry wholly supports . . . . And it is a far cry from the clearly unconstitutional threats and proposals to ban all DTC and HCP prescription drug marketing in the United States.” Any such ban on pharmaceutical DTC ads faces significant legal challenges related to First Amendment rights and procedural hurdles created by limitations on the power of federal regulatory agencies following its overturning of the Chevron doctrine. The memorandum implies that, given these risks, the administration would rather modify an existing standard to seek leverage or otherwise create negotiating power within a powerful (and cross-aisle politically connected) industry.

The purpose and commentary around this memorandum seem to primarily focus on social influencers – and even more specifically ads by pharmaceutical compounders (not major pharmaceutical brands). Social influencer ads have been widely accepted as skirting some longstanding rules. This type of marketing differs from DeepIntent's customers, which are primarily agencies and brand teams seeking to run regulatory and market compliant ads to appropriate audiences. However, there does appear to be a specific focus on the "adequate provision” exception, which has allowed advertisers to include only major risks in advertising and then direct consumers to another location for further details. Possible modifications to this rule may impact certain creative formats, such as shorter duration video creatives. However, online programmatic advertising through compliant platforms like DeepIntent gives access to a broad range of creative formats, and is thereby more adaptable to any potential rule changes.

But is this needed? And is it even possible? Among the general advertising industry, pharmaceutical advertisers are well known for their stringent policies and regulatory considerations when creating and serving advertising. It is hard to see the need or benefit of additional enforcements, given that the number of violations of existing rules has been effectively zero. In 2023, the Office of Prescription Drug Promotion (“OPDP”) reviewed nearly 70,000 pharma advertising submissions and issued only five enforcement letters for misleading promotions. There are serious questions as to whether the FDA has the resources to staff any stepped up enforcement efforts, given the dramatic cuts and resource reductions at FDA, including OPDP, which is responsible for the review of pharmaceutical advertisements. Moreover, enforcement under the current regulations and guidance that attempts to expand the enforcement criteria will be subject to legal challenges.

Here’s What’s Likely Next

Any measure to ban DTC advertising – whether it’s done directly or through the use of ‘back door’ rules causing a de facto ban – will be met with serious challenges on First Amendment grounds. Given this, we see three possible scenarios:

1. The FDA begins a formal rulemaking process on this, which requires process and public comment (a lengthy process), and will most likely be derailed by litigation;
2. The FDA tries a simpler “guidance change” process, which may be more efficient, but is subject to similar legal challenges; or
3. The FDA limits the scope of the proposed rule and guidance change, which may reduce litigation risk, but also creates a much smaller impact on the industry.

Any scenario above will either greatly delay or curtail regulatory implementation, and will happen over years – not days and weeks. This will allow time for pharmaceutical companies to adapt to the requirements, especially in the non-traditional (e.g., digital) advertising spaces.

The Bottom Line:What Should You Do Next?

In short, the headline-grabbing events of September 9th, maintain the status quo.  The studies cited point to largely outdated information about the benefits of DTC pharmaceutical ads, and are contrary to the use and value seen in practice.  Critically, what these actions do reinforce for brands and agencies is the following: 

• Do not react to vague letters and press releases – react to law and regulation (none of which has happened here).
• The need to work closely with their legal and compliance teams to align with the current ad standards in any medium.
• The importance of partnering with trusted organizations that proactively prepare for the changing winds of this industry through strong governance and policymaking.  

At DeepIntent, the Legal and Compliance Team has taken significant steps to prepare, respond, advocate, and educate its internal and external stakeholders.  DeepIntent will continue to provide ongoing updates, and will be monitoring the events in Washington. 

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