Warning issued over advertising new prescription-only weight loss pill

A warning has been issued to businesses on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management.

It comes after the UK’s first GLP-1 receptor agonist tablet for weight loss and weight management was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) last week.

The once-daily semaglutide (Wegovy) tablet, which is prescription-only, is expected to be available via private prescription ‘within weeks’ according to the manufacturer Novo Nordisk, and has been authorised to treat adults in the UK with obesity who have:

• A body mass index (BMI) of 30 or above; or
• A BMI between 27 and 30 and at least one weight-related comorbidity.

In a statement today, the MHRA said there have been recent examples of businesses promoting newly licensed oral GLP-1s, which are prescription-only medicines (POMs) – a breach of the advertising code.

Related Article: Carers of people with dementia report reaching ‘breaking point’

It has also seen the inappropriate promotion of ‘pipeline products’, such as newer forms of oral and injectable products used for weight management, including waiting lists for these products.

Together with the Advertising Standards Authority (ASA and the General Pharmaceutical Council (GPhC), the MHRA has issued a statement reminding businesses and health professionals of the CAP Code, which makes clear that medicines must have a licence from the MHRA before they are marketed and that prescription-only medicines or prescription-only medical treatments cannot be advertised to the public.

It said that where products are either still subject to regulatory review or are classed as POMs, referencing them by name or using language such as ‘GLP-1 tablets’, ‘oral GLP-1s’ or ‘the new weight-loss tablets’ is ‘likely to breach the code’, the statement said.

‘That includes where waiting lists for those medicines are being advertised.’

It added: ‘We are jointly emphasising the importance of reviewing advertising as a matter of priority to ensure all advertisers in the sector work within the rules.

‘The ASA will continue to work alongside its regulatory partners, such as the MHRA and the GPhC to ensure that patients remain protected and that professional standards are maintained.’

Julian Beach, MHRA executive director of healthcare quality and access, said: ‘The Human Medicines Regulations, including those provisions that relate to advertising of medicines, exist to protect the public.

‘These regulations prohibit the advertisement of a medicinal product for which there is no marketing authorisation in force.

Related Article: Rheumatoid arthritis patient trial backs up vaccination advantages of methotrexate delay

‘Creating consumer demand for a medicinal product by promotion of such a product before any UK regulatory appraisal for safety, quality and efficacy and subsequent authorisation has been completed is not permitted.

‘The regulations also prohibit the publication of an advertisement to the public likely to lead to the use of a prescription-only medicine.’

He added that a consultation with a healthcare professional is the ‘most appropriate way to determine suitable treatment options for an individual patient’.

‘It is vital that those who are responsible for marketing of treatment services understand the rules in place to protect consumers and remember their professional duty to safeguard healthcare consultations and decision-making,’ he said.

Related Article: Adjuvanted trivalent flu vaccine approved for over 50s

Roz Gittins, chief pharmacy officer at the pharmacy regulator, said the GPhC ‘will not hesitate to act where those that we register fail to meet our standards’.

‘This can include taking enforcement action against the pharmacy, the owner, the Superintendent Pharmacist, or individual registrants. We will continue to work collaboratively with other regulators to keep the public safe,’ she said.

Earlier this year the Nursing and Midwifery Council (NMC) reminded nurses that POMs and prescription-only treatments, including Botox, must not be advertised to the public and that doing so could result in suspension or a revoked licence to practice.