Agencies respond to promotions for weight-loss injections
**MHRA, ASA, and GPhC Issue Enforcement Notice on GLP-1 Receptor Agonists Advertising**
In a coordinated effort to protect public health, the Medicines and Healthcare Regulatory Agency (MHRA), Advertising Standards Authority (ASA), and General Pharmaceutical Council (GPhC) have jointly issued an Enforcement Notice to businesses offering GLP-1 receptor agonists, prescription-only medicines for weight loss.
The notice comes in response to rising concerns about the unlicensed and unregulated advertising of these medicines, particularly on social media platforms. The surge in popularity of GLP-1 receptor agonists, driven by increased public interest in weight management therapies, has led to a rise in promotional activities that may be outside regulatory compliance.
The joint enforcement notice aims to reinforce that only licensed indications, supported by robust clinical evidence, should be communicated. It seeks to protect consumers from inaccurate or incomplete information and to ensure that these medicines are used safely and appropriately.
Regulatory bodies have identified a pressing need to act promptly to prevent harm. The proliferation of digital and social media platforms has made it easier for unregulated or misleading ads to reach consumers. There have been increasing reports and complaints from healthcare professionals and the public about misleading ads related to GLP-1 receptor agonists.
The MHRA, ASA, and GPhC together regulate the pharmaceutical advertising landscape. Their joint notice signals a coordinated approach to address emerging issues around the marketing of GLP-1 receptor agonists, ensuring consistent enforcement across different channels.
GLP-1 receptor agonists are prescription-only medicines primarily indicated for conditions such as type 2 diabetes and, in some cases, obesity. However, there has been an increase in the advertising and promotion of these medicines outside of their licensed indications, sometimes targeted at healthy individuals seeking weight loss. Such advertising may not comply with legal and regulatory requirements, potentially misleading consumers about the benefits and risks.
The joint enforcement notice serves to reinforce that only licensed indications, supported by robust clinical evidence, should be communicated. It seeks to protect consumers from inaccurate or incomplete information and to ensure that these medicines are used safely and appropriately.
It is important for anyone seeking these treatments to be properly informed by a doctor of all the information needed to make a fully informed decision about using a GLP-1 inhibitor for weight loss. The medicines which are indicated for weight loss are indicated for a limited group of patients who are obese or significantly overweight and have a weight-related comorbidity.
The MHRA has issued a reminder page for healthcare professionals regarding GLP-1 receptor agonists (GLP-1 RAs), emphasizing the risks of gastrointestinal side effects, hypoglycaemia in non-diabetic patients, acute gallstone disease, pancreatitis, and serious allergic reactions. The MHRA states that these medicines are "acceptably safe when used within their licensed indications", but their safety for those outside the indicated group has not been studied.
The market for falsified GLP-1 RAs is a major concern for the MHRA, due to the size of the market and the lack of supply. Businesses, including clinics and pharmacies, are competing for this business through advertising, but no mention of the products themselves is permissible. Advertisers are warned to avoid indirect advertising - which is ads that describe a product but do not mention the name.
The new enforcement notice includes the GPhC because pharmacies are increasingly manufacturing these products individually per patient due to supply shortages. The Enforcement Notice was issued due to concerns about the advertising of these prescription-only medicines, particularly on social media. Some of the medicines listed in the Enforcement Notice are not indicated for weight loss but rather for diabetes, while others have been repurposed for weight loss.
The use of GLP-1 RAs off-label for weight loss purposes is a growing demand, with 64% of adults in the UK being overweight and 26.2% being obese. The MHRA notes the limitations of its own reporting system, as of 28 October 2024, the MHRA had received 7228 reports of gastrointestinal reactions associated with GLP-1RAs indicated for weight management, with 68 reports of hospitalization.
This enforcement notice is a relatively rare occurrence and is driven by the volume of breaches to date and the fact that these products are being used off-label and come with a list of side effects. The MHRA and regulatory partners stress the need for continued vigilance and compliance with advertising regulations to ensure the safe and effective use of GLP-1 receptor agonists.
- The regulatory bodies like MHRA, ASA, and GPhC have emphasized the need for adhering to legal and regulatory requirements in advertising GLP-1 receptor agonists, given their use in healthcare and medical-conditions such as type 2 diabetes and obesity.
- In light of the surging interest in health-and-wellness therapies, it's essential that media outlets be mindful of promoting GLP-1 receptor agonists, ensuring regulatory compliance and providing accurate information about these prescription-only medicines.
- The joint effort by regulatory bodies will focus on monitoring the advertising landscape, particularly on digital and social media platforms, to prevent harm to consumers and ensure that GLP-1 receptor agonists are utilized safely and effectively for their licensed indications in healthcare and medical-conditions.
