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September 10, 2025 0

Yesterday, President Trump issued a Presidential Memorandum instructing HHS and the FDA to revisit the rules governing direct-to-consumer (DTC) advertising for prescription drugs. The policy signals a return to pre-1997 requirements—when television ads were effectively impossible because they required the full Package Insert (PI) disclosure on-screen. Bob Ehrlich, CEO of DTC Perspectives, weighs in on what this could mean for advertisers, consumers, and the pharmaceutical industry.

Bob Ehrlich

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May 16, 2025 0

In the rapidly evolving landscape of direct-to-consumer (DTC) pharmaceutical marketing, data compliance has traditionally been viewed only as a necessity— which is often perceived as a constraint on marketing-driven growth, personalization, and operational agility.

The advent of artificial intelligence (AI) is revolutionizing this perspective, positioning data compliance as a strategic asset that enhances marketing effectiveness, improves data integrity, and reduces risk. Today’s AI technology not only automates and streamlines first-party data collection and handling but also facilitates collaboration, customized reporting, and stakeholder-specific recommendations.

The Evolving Landscape of DTC Pharmaceutical Digital Marketing and Media

In early 2023, the pharmaceutical industry surpassed the technology sector to become the second-largest industry in advertising spending, increasing its share to 14% of total ad expenditures, second only to the retail industry. This significant investment underscores the industry’s commitment to direct consumer engagement as the engine for marketing-driven growth. However, it also amplifies the challenges associated with ensuring that marketing strategies comply with stringent regulatory standards.

A recent study of the data compliance risks on pharmaceutical websites by the Association of National Advertisers (ANA) and Compliant[1] found that many healthcare and pharma websites failed to meet minimum standards for consumer data collection, consent, and data sharing. Companies like Better Help[2], Costco[3], and many others have found themselves in regulatory and legal crosshairs. Even industry associations have been targeted and found guilty by regulators[4], leaving marketers with no choice but to look for ways to own data compliance themselves.  This has led to a need for new tools to increase efficiency and accuracy in this critical area.

Without ethical guidelines and proper controls, large-scale consumer data collection, processing, and activation expose brands to significant liability and risk—often with minimal transparency or governance.

The rise of AI has expanded data compliance capabilities across multiple applications in the digital marketing business, including the ability to now build, create, analyze, enhance, and interact with consumer data in real-time in a “safe” and consistent manner. Done well, AI can empower marketing, technology, and compliance teams to operate together with greater precision and impact. AI’s ability to integrate compliance workflows with data optimization across websites, media campaigns, and cross-media applications adds unprecedented value for the DTC marketing process.

AI-Driven Data Compliance: A Strategic Asset

Traditional consumer data compliance processes in pharmaceutical marketing are often manual and time-consuming, leading to delays and inefficiencies. And while more than 70% of brands rely on agencies and partners to be educated and act in a legal and ethical fashion, less than one in four used automation to audit and verify data compliance across their digital marketing supply chain[5].

AI helps address these challenges by enabling detailed data compliance testing, verification and remediation across various digital platforms, including websites, applications, and media campaigns. AI-driven tools ensure real-time adherence to regulatory requirements, enabling marketing teams to execute privacy-first media campaigns swiftly and confidently.

Jamie Barnard, CEO of COMPLIANT, emphasizes, “Leveraging AI-driven data compliance is both a sword and a shield. Done right, it can transform this complex subject from a regulatory and business barrier into a competitive advantage. It allows DTC marketers to innovate confidently, technology teams to reduce time allocated and compliance teams to sleep well at night. And it saves money from fines and resources, making the CIO and CFO happy”

Enhancing Data Integrity and Media Quality

In DTC pharmaceutical paid media, the collection and utilization of first-party data are crucial for effective consumer engagement. Finding and marketing to consumers in the healthcare space presents some unique regulatory and legal challenges – not the least of which is privacy and data integrity.

AI-powered compliance platforms continuously audit data collection points, consumer interactions, consent frameworks and other quality metrics to ensure media campaigns are accurate, relevant, and compliant with privacy regulations. This helps both the customer and the company by leading to:

  • Improved Targeting: Ensuring that marketing efforts reach the appropriate audience segments.
  • Enhanced Personalization: Delivering tailored content that resonates with individual consumer needs.
  • Increased Consumer Trust: Demonstrating a commitment to data privacy and security.

Pete Dannenfelser, a pioneer in digital healthcare marketing communications, notes, “The unexpected value add of the integration of AI in compliance processes is that it not only mitigates risk, but also elevates the quality of our data, enabling more precise and impactful marketing efforts. This not only leads to better marketing, but delivers higher quality, more appropriate messaging for the customer.”

Fostering Continuous Collaboration Between Teams

AI facilitates seamless collaboration between compliance and marketing teams by providing unprecedented transparency and control, real-time insights, and automated reporting. This continuous alignment reduces the need for multiple meetings and streamlines communication, allowing teams to focus on strategic initiatives and objectives.

Shailee Vimadalal, a partner at ZS Associates, observes, “Implementing robust AI-driven compliance solutions fosters greater transparency and control, enabling marketing and compliance teams to work in harmony towards shared objectives.”

Real-World Application of AI-Driven Data Compliance in Digital Marketing and Media

Today, data compliance platforms are removing risk and enhancing marketing performance for leading consumer brands worldwide.

Consider a pharmaceutical company launching a new DTC campaign. With an AI-driven compliance platform, the company can:

  1. Confidently Activate Consented First Party Data : AI ensures that first-party data collection methods comply with privacy laws, maintaining data integrity.
  2. Ensure Compliant Media Buying: AI ensures the impressions, audiences and media purchased through agencies/DSPs and from digital media vendors (publishers, SSPs and other 3rd party data sources) are properly consented and have higher data integrity.
  3. Facilitate Cross-Functional Collaboration: Real-time compliance transparency, controls and insights promote a unified approach to campaign development which delivers greater trust and confidence to the organization.

This integration not only expedites campaign launches, but also helps ensure that all regulatory requirements are met, thereby enhancing the campaign’s overall integrity and effectiveness.

The Return on AI-driven Compliance

By embedding AI into compliance processes, pharmaceutical companies can transform a traditionally manual, reactive function into a proactive strategy that drives business value. The benefits include:

  • Operational Efficiency: Streamlining compliance tasks reduces time-to-market for new campaigns.
  • Risk Mitigation: Proactively identifying and addressing compliance issues minimizes the likelihood of regulatory penalties, lawsuits or reputational damages.
  • Enhanced Outcomes: Marketing-driven growth is predicated on finding the right customer, and serving them creative ads in context and with consent. Using data integrity and compliance metrics becomes an additional KPI.

Actionable Steps for DTC Marketers

To leverage AI-driven data compliance in digital media effectively, DTC marketers should:

  1. Assess Current Data Compliance Processes: Identify areas where AI can automate and enhance existing workflows.
  2. Invest in AI-Powered Compliance Tools: Select platforms that offer real-time monitoring and analysis of marketing activities.
  3. Promote Cross-Functional Collaboration: Encourage ongoing communication between marketing and compliance teams to align objectives.
  4. Stay Informed on Regulatory Changes: Utilize AI tools and services to monitor and adapt to evolving regulations, ensuring continuous compliance.

By adopting these strategies, pharmaceutical companies can turn compliance into a catalyst for innovation and a significant competitive advantage in the DTC marketing landscape.

Conclusion

The integration of AI into digital media data compliance marks a pivotal shift in DTC pharmaceutical marketing.

By automating compliance tasks, creating transparency among teams, enhancing data integrity standards, and fostering collaboration between marketing, IT and compliance teams, AI can transform compliance from a regulatory obligation into a strategic growth opportunity.

Pharmaceutical companies that embrace AI-driven compliance solutions are better positioned to navigate the complex regulatory environment, drive innovation, and achieve sustained success in the competitive DTC market.

 

Sources:

[1] 2024 ANA Compliant Website Benchmark Report (LINK)

[2] FTC Better Help announcement (LINK)

[3] Costco sued for Facebook pixel placement on Pharmacy homepage (LINK)

[4] IAB TCF framework judged illegal (LINK)

[5] ANA Compliant report

Ian Wolfman

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February 14, 2025 0

Pharmaceuticals joined the big advertising game in New Orleans, running two :60 spots. They were not ads for a particular brand but were corporate type messaging. Novartis focused on breast cancer in what was a unique creative montage of showing breasts in a myriad of situations both real life and in art. This ad was certainly 180 degrees different from what would be expected in a drug company breast cancer awareness ad. For about 40 of the 60 seconds the theme was just look at the breasts with a musical background saying “I know you are looking.” Actress Hailee Steinfeld was part of the montage.

Then, in the last 20 seconds, a more conventional looking appeal started for diagnosing breast cancer with comedian Wanda Sykes. She encouraged patients to get early detection and treatment. Clearly Novartis wanted to break the mold of the standard disease education ads. They did.

You can’t be boring, and Novartis and Pfizer certainly met that requirement.

Pfizer was also up to the creative task with its highly engaging cancer research ad. Showing a child in a hospital bed who then gets up and parades through the streets in a Rocky-like scene with boxing attire. A super appears saying to cancer that we are going to knock you out. Singer LL Cool J provides the background song. Then the ad closes with a super saying Pfizer is working on drugs for eight different cancer breakthroughs by 2030.

Both ads are excellent in getting the stopping power needed for a Super Bowl entry. You can’t be boring, and Novartis and Pfizer certainly met that requirement. Each ad left you guessing what the ad was for until its last third. This is in keeping with Super Bowl ads in general trying to hook you on a story before revealing the sponsoring brand or company.

Branded drug ads are just not going to work on the Super Bowl. Spending millions on an ad with half devoted to risks and side effects does not make sense. That brings us to a third drug ad, but not from a drug company. Hims & Hers, a direct seller in many drug categories, ran a provocative ad critical of the cost of drugs and saying the health care system is not working for us. The first part of the ad was on obesity disease education; fairly standard stuff. Then the ad tore into the weight loss industry for failed approaches and pharma for high prices. Then it turned to how Hims & Hers has affordable meds made in the USA.

Congress is concerned that companies like Hims & Hers are advertising drugs with no fair balance. Proposed legislation would treat these drug sellers similarly to pharmaceutical companies. After all, they are making drugs through compounding and are trying to diagnose and sell directly. Sounds like a drug maker. Why are they able to compete with drug companies but allowed to eschew fair balance? These compounded drugs carry risks and side effects similar to Wegovy or Zepbound. Hopefully Congress will impose reasonable requirements to add fair balance as these types of direct sellers are booming. The Hims & Hers ad was attention getting and tapped into the concerns consumers have about GLP prices. That said, it is ironic the only Super Bowl drug ad was not from a drug company.

 

Bob Ehrlich

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January 14, 2025 0

I’ve been pondering what the revolution in artificial intelligence (AI) truly means for DTC marketing. Can my aging brain grasp how AI works? Does it mean DTC advertising could be developed without engaging real patients, or even without agencies crafting the ads? Could we one day see virtual pharma marketers? Imagine our annual Top DTC Marketers list featuring artificial entities — what a surreal awards dinner that would be!

After speaking with experts, it’s clear that AI offers DTC marketers a vast ocean of opportunities. The potential benefits span the entire spectrum, from concept testing to producing polished ads. Faster copy development, reduced costs, and more options to present to real patients could redefine the process. Envision a world where virtual focus groups test ad concepts in mere seconds. Every target group could evaluate countless concepts, with AI instantly refining them until the ideal message emerges.

AI offers DTC marketers a vast ocean of opportunities, from faster concept testing to personalized ad creation.

Imagine media teams using AI to virtually identify the optimal omnichannel mix, tailored to every patient target group. The current array of media choices is already overwhelming. AI could enable us to explore every option at a micro level, creating unparalleled precision.

We’ve already seen digital advertising move in this direction. However, DTC remains television-centric, with about 60% of spending focused there. Most consumers are exposed to just a few ad executions per brand. AI could change that dramatically, enabling instant variations that adapt to the viewer. Those three standard ads could become 300, each optimized for the audience in real-time.

Of course, significant challenges lie ahead. The steep learning curve of adopting AI will inevitably slow its widespread use. Internal legal and regulatory reviews remain essential. The OPDP may also struggle to oversee a world of hundreds of promotional variations.

The advice from AI experts is clear: experiment with the tools available now. Adoption will take time, but starting small is the first step for pharma marketers. Ultimately, AI is a tool for human marketers to create more personalized and effective ads. My hope is that AI will lead to more creative, distinctive ads that cut through the clutter of DTC advertising.

Every pharma marketer should challenge themselves, their agencies, and their research partners to integrate AI into their processes. Start small, experiment, and see where AI can lead you. The journey will undoubtedly be challenging, but the potential rewards make it a path worth exploring.

Bob Ehrlich