This article is co-authored by Sarah Nelson and Mojca Njegač from ACMEdica Medical Writing Solutions.

Promotional, or brand-focused assets are among the most complex and creative projects in med comms. Designed not only to educate but to sell, these pieces rely on impact-heavy copy laden with clear and factual key messages.

As medical writers working on promotional materials, our job is to promote our clients’ products and services in a way that is both effective and ethical. But, we’ve all heard stories of companies crossing the line and misleading consumers with false, exaggerated or lacking claims. How do we as medical writers make sure we’re not contributing to the problem of misleading or exaggerated promotion?

Enter: regulations.

Regulations are not there to make our lives more difficult. Just like a superhero’s trusty sidekick, they keep us from veering off the path of righteousness into the land of shady business practices. You don’t want to be the villain in this story.

Medical writers have the power to shape the way healthcare professionals perceive and understand healthcare products and services. And with great power comes great responsibility. While politicians may have the luxury of tweeting about ‘safe’ vaccines, it is the medical writer’s duty to ensure that materials we create accurately and ethically reflect all of the potential dangers as well as benefits of the products we promote.

Without regulation, pharmaceutical companies could make all manner of unsubstantiated claims about their products. Can you imagine a world where materials could promise to cure Alzheimer’s with a single pill? Or ‘Crush, Kill, Destroy’ an infection? Regulation ensures that advertisements are presented in a way that is truthful, not misleading, and not likely to cause harm.

Beginners in medical writing may be wondering where to start when it comes to understanding and adhering to industry regulations. Here are a few basic concepts to begin with:

• Support product claims with scientific evidence
• Disclose potential risks or side effects associated with pharmaceutical products
• Avoid making claims that exaggerate the product’s capabilities
• Don’t make any claims that could cause harm to the consumer

It’s important to stay informed about the guidelines and regulations set forth. While the core aim remains unwavering – to furnish the public with the most authentic and impartial information – the global landscape is dotted with different guidelines and regulations.

You’ll find detailed guidance in regional regulations including those from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). These are supplemented by local regulations such as those in the UK known as the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.

In the European Union, the rules of drug promotion are laid down in the Human Medicinal Products Regulation and the Human Medicinal Products Directive. These become especially stringent when it comes to promoting prescription-only medicines. While over-the-counter drugs can be advertised directly to consumers, the promotion of prescription-only medicines is restricted to healthcare professionals only.

However, if authorised, advertising to the general public must be easily recognisable as an advertisement and provide all necessary information for the correct and safe use of the product. The advertisement must encourage the public to carefully read the instructions manual and promote responsible drug use. Additionally, any mention of therapeutic uses where self-medication is not suitable is strictly forbidden.

It’s essential to stay informed and up-to-date with these regulations. Not only will it protect you and your clients from any legal consequences, but it will also guarantee that the information being shared with patients and healthcare professionals is truthful and ethical. So let’s strive to inform, not mislead.

Happy writing!

P.S. – For those looking to dive deeper into the topic, here are a few useful links:

• FDA guidance on advertising and promotion: https://www.fda.gov/animal-veterinary/guidance-industry/advertising-and-promotion-guidances
• ABPI Code of Practice: https://www.abpi.org.uk/reputation/abpi-2021-code-of-practice/
• Access to European law on medical products advertisement: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM%3Al21143
• International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) guidance: https://ifpma.org/areas-of-work/upholding-ethics-and-business-integrity/