HBW Insight is shining a spotlight on the work of regulatory affairs specialists operating in and supporting the consumer health and cosmetics industries. We are profiling this important role, hearing what a typical day involves and finding out what is top of mind for these individuals today. Look out for further installments in this series in HBW Insight over the coming weeks.
Making sure that medicines advertising follows the rules of a particular market is an art that if done poorly, can be costly both financially and in terms of a company’s reputation.
This is an art that is being increasingly outsourced as the consumer health industry moves closer to the fast-moving consumer goods sector, reveal Lucy Rochford and James Walmsley in this latest instalment of HBW Insight’s Inside Regulatory Affairs.
As an outsourced copy review specialist, Rochford and Walmsley’s “fairly new” company AdverCheck has benefited from this change.
Based on their experience, they advocate for keeping the copy review process “simple, clearly defining roles and responsibilities, and developing basic guidelines and checklists.”
However, they point to a worrying trend of advertising prescription-only medicines (POMs) online. Aside from being illegal in the UK, Rochford and Walmsley note concerns surrounding the “lack of online prescriber oversight.”
Given that in many categories consumers “now have a direct choice between buying a medicine OTC or obtaining a POM online with similar ease,” they suggest that this “blurring of the lines between OTC and POM medicines also risks undermining enthusiasm for Rx-to-OTC switches.”
What is a typical day in the life of a regulatory affairs specialist?
AdverCheck specializes in outsourced copy review, which is variously considered a regulatory or medical affairs function. On a typical day, we would be working with a range of different clients, including consumer healthcare companies, creative agencies and online pharmacies. We may be reviewing website articles, TV campaigns, sales display materials or specialist copy aimed at healthcare professionals. The products we work on range from OTC medicines to consumer medical devices, food supplements and borderline products. So every day is different!
Our priorities reflect those of our clients, who are looking for an expert and trusted partner to review copy promptly and to a high standard. We encourage clients to see copy review as an enabling function - involving us early during campaign development means that potential barriers can be anticipated and addressed. Our expertise in data interpretation also means we can help companies develop new product claims.
How has this role changed over time?
AdverCheck is still a fairly new company, but we’re already trying to evolve to provide the types of services our clients need.
We started AdverCheck because we saw an unmet need for an outsourced copy review provider specialising in consumer healthcare. There has been an increasing trend towards outsourcing copy review in the pharma sector, and we’re seeing a similar need in consumer healthcare companies. Regulatory and medical affairs departments are often under-resourced and increasingly expected to focus on growth rather than day to day activities. We are also seeing internal resources further squeezed in companies who have made the transition from pharma divisions to standalone consumer healthcare companies, where the resourcing benchmark is the FMCG sector.
Through working with our clients, we have seen opportunities to extend the services we offer to address some of their pain points. We now offer mentoring to staff new to copy review, allowing junior staff to develop copy review skills over time, using “live” materials. We also advise on wider aspects of copy review, and have worked with companies on referencing guidelines, improving awareness of the basic principles of copy review, and developing simplified procedures. From our experience, most companies could benefit from keeping the process simple, clearly defining roles and responsibilities, and developing basic guidelines and checklists.
Most recently, reflecting the renewed interest in switch, we have also started offering services to companies looking to switch medicines from prescription-only medicine (POM) to pharmacy (P) status in the UK. Our team can offer expert advice on candidate selection, feasibility, assessment against the prescription criteria and support for agency meetings.
What is currently keeping you up at night?
We specialize in consumer healthcare, so our hopes and fears reflect those of the sector in general. One of the seismic changes over recent years has been the increasing online commoditization of prescription-only medicines (POMs). Like many others, we are concerned about the public health implications of the “ePommerce” market. The market is driven by advertising of POMs to consumers, and there have been concerns surrounding the lack of online prescriber oversight. There are also significant negative impacts of ePommerce for companies who market OTC brands, given that in many categories consumers now have a direct choice between buying a medicine over the counter, or obtaining a POM online with similar ease. This blurring of the lines between OTC and POM medicines also risks undermining enthusiasm for POM-P switches.
What is your company doing to deal with these challenges?
Our first interest is to serve the needs of our clients, including those who offer online services which include POMs. We recognize that some companies may simply not be aware that POMs may not be advertised to consumers, while others may struggle to stay within the guidance. So we’re here to support and advise online pharmacies and telehealth providers to ensure their services support self-care appropriately and compliantly.
Bio
AdverCheck Ltd was launched in 2022 by Lucy Rochford and James Walmsley to provide specialist outsourced copy review and related services to the consumer healthcare sector.
Rochford and Walmsley are seasoned professionals with complementary expertise covering the advertising codes, the advertising regulatory framework, data interpretation, claims building and POM-P switch.
Rochford is a former Head of Copy Clearance at UK consumer healthcare industry association, PAGB, with a detailed knowledge of the UK advertising codes and the regulatory environment.
Walmsley is a pharmaceutical physician with 20 years industry experience in medical affairs and advertising review within the consumer healthcare sector. After working at Boots, Walmsley served as UK medical director for both Pfizer Consumer Healthcare and Johnson & Johnson, leading the team responsible for advertising review.
