According to the Section 2 of Canada’s Food and Drugs Act, an advertisement includes “any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.”1
Promotion can take on many forms, including:2
Regulatory systems are in place to safeguard the public from false and misleading advertising of healthcare products. However, among jurisdictions, these systems differ on what constitutes advertising and promotional activities, and thus their regulations and enforcement vary as well.3 To ensure you comply with industry regulations, understand the local requirements. 3,4
In Canada, advertising is primarily self-regulated and materials are submitted for preclearance on a voluntary basis. Health Canada is ultimately responsible for enforcement (for example, in cases when advertising may present a significant health hazard such as when a prescription drug is illegally advertised to the general public or an unauthorized health product is promoted). However, many preclearance activities are delegated to associations such as Rx&D (for review by their Code of Marketing Practices committee), Advertising Standards Canada (ASC) and the Pharmaceutical Advertising Advisory Board (PAAB).
South of the border, the U.S. Food and Drug Administration (FDA) regulates the advertising of prescription drugs via the Division of Drug Marketing, Advertising, and Communications (DDMAC), and of “restricted” medical devices* via the Centre for Devices and Radiological Health (CDRH). Other devices and over-the-counter drugs are regulated by the Federal Trade Commission (FTC). In most cases, the submission of advertising materials to the FDA is voluntary, with the exception of products that are approved via the accelerated approval process, and “restricted” medical devices. Other than New Zealand, the US is the only country that allows direct-to-consumer advertising of prescription products.
In the EU, advertising regulations vary per country. In the UK, for example, advertising is controlled by both statutory measures (with both criminal and civil sanctions) enforced by the Medicines and Healthcare products Regulatory Agency (MHRA), and self-regulatory measures (through voluntary codes of practices) administered by trade associations.
Further to legislation and to guidance documents published by regulatory agencies, pharmaceutical and medical device associations also publish voluntary practices related to the advertising of healthcare products. These associations and their publications include:
If your company develops healthcare products, establish standard operating procedures (SOPs) that relate to your advertising and promotional activities. These SOPs will help ensure the proper training of your employees. The SOPs adhere to relevant regulations and applicable voluntary industry standards. Having these will help you stay in compliance and thus avoid any enforcement action from the regulatory bodies. Such enforcement can include warning letters, the publication of a corrective advertisement, or even legal proceedings, including criminal charges.3,4
Keep in mind the following key points when developing advertising and promotional materials:
*In the US, most class III Premarket Approval medical devices have been restricted as a condition of approval, in accordance with section 515(d)(1)(B)(ii) of the US Federal Food, Drug, and Cosmetic Act. A few class I and II devices (for example, hearing aids) are restricted by regulations in accordance with section 520(e) of the same act.6 Disclaimer
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012