For healthcare products, what counts as promotion or advertising?
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
- Internet sites
- Exhibition panels
- Product monographs
- A sales representative’s activities
- Training materials or briefings
- Press releases
- Meetings or symposia
Different regulatory bodies have different views on advertising healthcare products
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.
Voluntary practices for advertising
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:
- International Federation of Pharmaceutical Manufacturers & Associations (IFPMA): Code of Pharmaceutical Marketing Practices
- European Federation of Pharmaceutical Industries and Associations (EFPIA): Code of Practice on the promotion of prescription-only medicines to, and interactions with, health professionals
- EFPIA: Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations
- World Health Organization: Ethical criteria for medicinal drug promotion
- International Pharmaceutical Congress Advisory Association (IPCAA): Healthcare Congress Guidelines
- Association of the British Pharmaceutical Industry (ABPI): Code of Practice for the Pharmaceutical Industry
- Pharmaceutical Advertising Advisory Board (PAAB) [Canada]: Code of Advertising Acceptance
- Pharmaceutical Research and Manufacturers of America (PhRMA):
- Code on Interactions with Healthcare Professionals
- Guiding Principles―Direct to Consumer Advertisements About Prescription Medicines
- AdvaMed: Code of Ethics on Interactions with Health Care Professionals
SOPs to keep your advertising in compliance with regulations
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:
- Promotional activities should be consistent with the product labelling that has been cleared or approved.
- Promotional claims should be reliable, accurate, truthful, informative, fair, balanced and up-to-date, and you must be able to substantiate them.
- The information should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable product use or to give rise to undue risks.
- Any comparison of products should be factual and fair, and you must be able to substantiate it.
*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
- Canada. Food and Drugs Act. Retrieved September 25, 2012, from http://laws-lois.justice.gc.ca/eng/acts/F-27/page-1.html.
- Woods, P. (2001, December 4). Promotion of Medicines. BIRA. Regulatory strategy: the marketplace. [Presentation].
- de Wet, C. (2009). Chapter 12. Information and promotion. In Griffin, J.P. (Ed.), The textbook of pharmaceutical medicine (6th ed.). West Sussex: John Wiley & Sons Ltd.
- Drake, K.L. (2009). Chapter 9. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices. In Pisano, D.J., Mantus, D.S. (Eds.), FDA regulatory affairs. A guide for prescription drugs, medical devices, and biologics (2nd ed.). NY: Informa Healthcare.
- United States Code. Title 21, Part 814.80 General, Subpart E, Post approval requirements, Premarket approval of medical devices.
- United States Code. Title 21, Part 814.82(c), Post approval requirements, Premarket approval of medical devices.
- Europa. (2001, October 19). Misleading and comparative advertising. Retrieved July 20, 2012, from http://europa.eu/legislation_summaries/consumers/consumer_information/l32010_en.htm.
- Sucher, J.F., Jones, S.L. & Montoya, I.D. (2009). An overview of FDA regulatory requirements for new medical devices. Expert Opinion Med. Diagn. 3(1): 5-11.
- U.S. Food and Drug Administration. (2009, July 22). FDA Oversight of Direct-to-Consumer Advertising of Medical Devices. Retrieved August 11, 2012, from http://www.fda.gov/NewsEvents/Testimony/ucm096272.htm.
- U.S. Food and Drug Administration. (2009, June 23). Prescription Drug Advertising: Questions and Answers. Retrieved July 20, 2012 from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/UCM076768.htm#control_advertisements.