Updates from FDA’s Office of Prescription Drug Promotion: Standards for Direct-to-Consumer Advertising

In a recent presentation at the 25th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, Catherine Gray, the Director of the Office of Prescription Drug Promotion (OPDP) at the FDA, outlined significant regulatory updates affecting the way prescription drugs are advertised directly to consumers. Her talk focused on the recent implementation of the Clear, Conspicuous, and Neutral (CCN) Final Rule and other initiatives designed to enhance the transparency and comprehensibility of direct-to-consumer (DTC) drug advertisements.

Overview of the CCN Final Rule

The CCN Final Rule amends 21 CFR 202.1, stipulating that advertisements for human prescription drugs presented directly to consumers on television and radio must clearly state the drug’s major side effects and contraindications. This amendment arises from the Food and Drug Administration Amendments Act of 2007, emphasizing the need for clarity, conspicuousness, and neutrality in DTC advertisements.

Key Features of the CCN Final Rule:

• Consumer-Friendly Language: Advertisements must avoid medical jargon, instead opting for terminology that is easily understood by the general public.
• Dual Modality Requirement: For television ads, the major statement about side effects and contraindications must be presented simultaneously in both audio and text formats, ensuring that the information is accessible to all consumers, including those with hearing impairments.
• Visual and Auditory Clarity: The text must be easy to read, and the audio easy to hear, with both elements synchronized to begin and end together.

Enhanced Guidance for Digital Marketing

Director Gray also addressed the evolving challenges of digital and social media marketing. The FDA has updated its addressing misinformation guidance to assist companies in managing misinformation about their products online. This includes new protocols for companies to voluntarily correct misinformation, particularly when it is spread by independent third parties.

Key Points on Digital Marketing Guidance:

• Managing Misinformation: Companies are encouraged to engage actively in correcting misinformation about their products on digital platforms.
• Tailored Responsive Communications: These are defined as voluntary, internet-based communications that identify and correct misinformation about a company’s products created by independent third parties.

Regulatory Submissions and Tools for Compliance

Gray emphasized the importance of proactive compliance through voluntary comment requests from the FDA on draft DTC ads before public dissemination. The OPDP has also released updated compliance guides and FAQs to help companies navigate the new advertising standards effectively.

Collaborative Efforts and Stakeholder Engagement

The FDA continues to collaborate with stakeholders to refine promotional practices for prescription drugs. This includes joint meetings with the Duke Margolis Center to discuss the future of drug promotion in the digital age and initiatives like the Bad Ad Program, which educates healthcare providers on identifying and reporting misleading promotions.

Recent Enforcement Actions by FDA’s OPDP

Catherine Gray highlighted the FDA’s proactive measures in enforcing advertising regulations, by detailing recent compliance letters sent to companies over violations in their advertising practices. Here is an overview of the companies that received enforcement letters and the specific circumstances around these violations:

Companies That Received Enforcement Letters

1. Evofem Biosciences for Phexxi (lactic acid, citric acid, and potassium bitartrate) Vaginal Gel:
   • Date of Letter: October 31, 2023
   • Violation: An untitled letter was issued to Evofem Biosciences due to false or misleading claims about the efficacy of Phexxi in a direct-to-consumer brochure. The FDA criticized the company for promotional materials that exaggerated the benefits without substantial evidence.
2. Otsuka Pharmaceutical for Rexulti (brexpiprazole) Tablets:
   • Date of Letter: October 31, 2023
   • Violation: Rexulti was cited in an untitled letter for misleading representations in a direct-to-consumer television advertisement and a banner ad. The FDA found that the ads made efficacy claims that were not supported by clinical evidence.
3. Novartis for Kisqali (ribociclib) Tablets:
   • Date of Letter: January 18, 2024
   • Violation: Novartis received an untitled letter for false or misleading representations about the efficacy of Kisqali in a direct-to-consumer television advertisement. The claims about improved quality of life were deemed misleading as they were based on exploratory assessments rather than solid clinical evidence.
4. Kaleo for Auvi-Q (epinephrine injection, USP):
   • Date of Letter: July 17, 2024
   • Violation: Kaleo was issued an untitled letter for a social media post that completely omitted risk information on a drug, crucial for ensuring consumer safety.
5. Mirati Therapeutics for Krazati (adagrasib) Tablets:
   • Date of Letter: August 1, 2024
   • Violation: Mirati Therapeutics received an untitled letter addressing false claims about the efficacy of Krazati on a healthcare provider branded website. The promotional communications suggested benefits that were not substantiated by the available data.
6. AbbVie for Ubrelvy (ubrogepant) Tablets:
   • Date of Letter: August 29, 2024
   • Violation: AbbVie was issued an untitled letter for misleading suggestions about the efficacy of Ubrelvy in a direct-to-consumer television advertisement. The ad suggested faster action and more effective relief than was demonstrated by the clinical evidence.

Lessons for Industry

These enforcement actions underscore the FDA’s commitment to monitoring drug promotions and its readiness to take action against misleading advertisements that could jeopardize public health. Pharmaceutical companies are urged to ensure that their promotional materials not only comply with regulatory standards but are also backed by robust scientific evidence. Simple disclaimers or fine print are not sufficient to offset misleading claims if the underlying data does not support them.

Conclusion

Catherine Gray’s insights during the presentation illustrate the FDA’s unwavering dedication to protecting public health through rigorous oversight of prescription drug advertising. The introduction of the CCN Final Rule and the enhancements in digital marketing regulations demonstrate the FDA’s proactive stance in aligning its regulatory frameworks with ongoing technological progress and shifts in consumer interaction. These strategic updates are vital for upholding the accuracy and reliability of drug information available to the public, ensuring that consumers are well-informed and can make sound decisions regarding their health care based on factual and clear data.

Additional Resources

FDA OPDP CCN Final Rule

FDA FAQ’s on CCN Final Rule

FDA Draft Guidance on Misinformation