2022-04-13 17:30:12
The Medicines and Healthcare products Regulatory Agency (MHRA) has just published its annual report for 2021 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1061427/Annual_Report_2021.pdf
Amongst other things:
- The MHRA received 144 complaints, significantly down on 2020 and 2019.
- 53 complaints led to investigation and 89 were referred to other bodies such as the Advertising Standards Authority (ASA).
- Many of the referrals to the ASA related to adverts for botulinum toxin products, prescription -only weight-loss treatments and injectable vitamin products.
- A high proportion of complaints concerned the advertising of prescription only medicines (POMs) to the public by cosmetic clinics and other service providers, including online clinics and pharmacies. These complaints included ‘off-label’ promotion for an indication for which the product does not have a licence); promotion of unlicensed medicines; and advertisements that did not make clear an OTC product was being promoted.
- The proportion of complaints that relate to advertising on social media continues to rise and the majority of cases investigated related to online treatment service providers (third parties) offering POMs and/or unlicensed medicinal products for prescription.
- The majority of complaints were upheld, leading to withdrawal of, or changes to advertising.
Looking at the types of cases investigated:
- 5 complaints were upheld against marketing authorisation holders: 2 in the prescription sector and 3 in the over-the-counter (OTC) medicines sector.
- In the prescription sector, 1 case concerned an advertisement for a medical device that promoted a POM to the public, and 1 case concerned promotion of unlicensed medicines (specials) to prescribers.
- In the OTC sector, the cases were: promotion of a pain product targeted at healthcare professionals that did not contain the required statutory particulars; use of a celebrity social media account to encourage use of a medicinal product; and MHRA scrutiny review of a traditional herbal remedy, the advertising for which included a prohibited recommendation from a healthcare professional to use the product.
- The MHRA reports a rising number of complaints relating to the third-party promotion of unlicensed medicines, particularly within the men’s healthcare and skincare online sectors.
The MHRA attributes the low number of investigations into pharmaceutical companies to self-regulation through the work of PAGB which reviews advertising for OTC medicines by their members prior to publication.