Navigating New FDA and Health Canada Advertising Regulations
In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs. [2] Meanwhile, new Canadian Health guidelines were introduced in 2024 on Real-World Evidence/Data (RWE/RWD) in advertising to healthcare professionals. [3] In 2023, Health Canada updated guidance on the distinction between advertising and other activities for health products [4]. We are currently seeing an increased regulatory focus on promotional materials, especially in North America. However, the FDA and Health Canada take different regulatory approaches to advertising and promotional compliance. Here we explore the impact, and strategies for compliance.
FDA approach on promotional compliance in the US
In the US, regulations on prescription drug advertising and promotion are within the brief of the FDA and outlined in 21CFR202.1 [5]. This provides detailed guidance on content and how the product is presented in advertising and promotional material (e.g. listing ingredients in the right order, using correct names, avoiding exaggerated or false claims). Its Office of Prescription Drug Promotion (OPDP) is responsible for reviewing advertising and promotional material. In most cases, this must be submitted at the time of dissemination, which is generally done using FDA Form 2253. However, the OPDP does provide opinions on request prior to release of the material for prescription drugs, and special review rules apply to accelerated approval pathways. [6] Off-label claims in advertising and promotion may also contravene the False Claims Act (FCA).
Health Canada’s approach to compliance in advertising
Canada has much more restrictive regulations on promoting prescription drugs, set out in its Food & Drugs Act (F&DA) [7], Controlled Drugs and Substances Act [8] and various guidelines, codes and associated regulations. [9] While the scientific data for a prescription drug is generally very similar in the US and Canada, there are vast differences in what can be disseminated and to whom, and how promotional material is reviewed. Advertising to healthcare professionals must follow certain codes aligned with Health Canada regulations. Advertising directed at the general public is confined to the brand name, common and proper name, price and drug quantity. This is often called “Reminder advertising.” [10] Anyone who has been prescribed drugs, however, is excluded from this definition of general public according to updated definitions and under certain circumstances may receive promotional material. [11] [12]
Responsible bodies for compliance of advertising and promotional material
Canada has gone down the path of a self-regulatory approach, with various bodies regulating promotional material through accepted codes of practice. The most important of these is Pharmaceutical Advertising Advisory Board (PAAB): Code of Advertising Acceptance (PAAB Code) [13]. This independent organization is the only one recognized by Health Canada for preclearance of advertising directed at healthcare professionals.
In the US, the FDA-internal Office of Prescription Drug Promotion (OPDP) will review voluntary submissions of promotional material (directed at any party) for OPDP compliance before it is disseminated, and mandates submission once disseminated. It therefore plays an important post-marketing watchdog role. PAAB offers preclearance voluntarily ahead of dissemination to healthcare providers (HCPs), and if this conforms with the PAAB guidelines (Code of Advertising Acceptance), advertising material may bear the PAAB logo. This requires membership of PAAB. [14] It also offers an advisory service for direct-to-consumer services, but this is not covered by the code. Furthermore, it adjudicates complaints from manufacturers and healthcare providers, and monitors advertising in the marketplace.
Impact on pharmaceutical companies and regulatory professionals in North America
• Stricter oversight and enforcement
Greater scrutiny of advertising and promotional materials leads to a higher likelihood of warning letters, fines, or legal action in instances of non-compliance. Off-label promotion compliance is one very high-risk area. The consequences of non-compliance include direct financial costs as well as loss of patient trust and damage to product and corporate reputation. Companies are already feeling the increase in regulatory pressure, and one act of non-compliance leads to even greater scrutiny of a company.
• Potentially strained budgets and need for resource reallocation
In response, companies must invest more in robust compliance strategies, including training and internal audits, and implement more thorough legal reviews of advertising and promotional material. Watertight processes and workflows must be implemented. Workloads are increasing, demanding new efficiencies (e.g. technological, organizational).
• Digital marketing challenges: A perfect storm
The complexity of digital marketing, combined with stricter oversight, highlights the importance of preclearance for both physical and digital advertising. While the extension of media formats and communication channels (e.g. apps, platforms) allows for greater differentiation and better targeting, it also poses significant challenges in maintaining consistency across advertising formats and markets.
Regulatory bodies are implementing guidelines to address the challenges of digital marketing. These include rules for:
• Online advertising and promotion on dedicated platforms
• Social media
• Influencer partnerships (e.g. moves for stricter guidelines for influencers in the US)
• Electronic labeling (e-labeling)
At the same time, the pharma industry is shifting towards greater patient-centricity, particularly in the US, through personalized advertising.
Many companies lack efficient processes to manage hybrid communications (both physical and digital) and the higher volume of messaging.
• Regulatory professionals face higher workloads
Greater focus on advertising and promotion is leading to change (also to account for digital possibilities today), and change strategies must be built into workflows across all teams: marketing as well as medical, legal and regulatory (MLR) teams. Knowledge management requirements increase, while staying abreast of current regulations becomes more difficult. Along with change and the need to stay abreast with regulations, regulatory affairs professionals are a facing higher volume of messaging – all leading to increased workloads and higher risk.
Key strategies for compliance with OPDP guidelines and PAAB Code
- Understand your regulatory environment, which requires training and expertise for particular markets. Your press release on a new product may be compliant in the US, but the same press release is likely to be non-compliant in Canada.
- Plan early. Lay the groundwork for promotional compliance well in advance. Implement watertight workflows, build processes, and consider external expertise to ensure compliance readiness with OPDP and PAAB requirements from the start.
- Regularly update core claims documents to reflect all regulatory requirements, especially OPDP and PAAB requirements. This includes using approved current materials like product labeling and approved promotional content whenever possible.
- Clearly define media formats, target audiences, and promotional goals, ensuring that these meet regulatory standards and codes of OPDP and PAAB.
- Make sure you have the staff or external resources at hand with expertise in Medical, Legal, and Regulatory (MLR) to guarantee that all promotional materials are compliant.
- Leverage technology to reduce workloads and compliance risks in promotional materials. Automated tools accelerate the proofreading and review process, promote a culture of “right-first-time”, and ensure greater accuracy and compliance with OPDP and PAAB standards.
- Submit all promotional materials to the relevant body or authority for review/preclearance in a timely fashion.
- Appoint knowledge owners and maintain real-time monitoring and review workflows to ensure ongoing compliance.
