Essentials of European Medical Device Regulatory Affairs

Case 2

A website, www.flexiseq.com, for Flexiseq a gel for osteoarthritis, seen on 2 October 2017, featured text stating that the product was a “drug free, sustainable approach to joint pain and stiffness, clinically proven to treat osteoarthritis as effectively as a prescription painkiller*” and cited “* 100mg celecoxib 2x daily for 12 weeks. Conaghan P et al. Rheumatology 2013 Jul;52(7):1303-12”. The website also listed benefits of the product including “Relieves pain and joint stiffness” and “Improves mobility and physical function”.

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Case 2 - Complaint received by ASA

• The complainant, a GP, who believed the cited paper did not substantiate the claims, challenged whether the claim that Flexiseq was "clinically proven to treat osteoarthritis as effectively as a prescription painkiller” was misleading and could be substantiated

• What are your thoughts?

• https://www.asa.org.uk/rulings/pro-bono-bio- entrepreneur-ltd-a17-400871.html

The Organisationfor Professionals inRegulatory Affairs