ASA U-turn: Omega Pharma ruling reversed after UK medicines agency input
The ASA previously said Omega Pharma’s advert for its over-the-counter (OTC) botanical Urostemol Men was irresponsible and potentially harmful in that it could discourage men from seeking medical advice for more serious causes of overactive bladders like prostate cancer, diabetes or urinary tract infections.
The company sought an independent review of the May ruling, which revealed the ASA had omitted advice on the licensed Traditional Herbal Remedy (THR) from the UK regulator responsible for such products, the Medicines and Healthcare products Regulatory Agency (MHRA).
‘Human error’
“Whilst we aren’t bound by advice that it gives, we can, and do, seek the MHRA’s view on such matters. In this instance, however, due to human error the initial feedback that MHRA provided to us was not viewed as sufficiently significant to be seen by [ASA] Council,” ASA press officer Matt Wilson told us.
“When, following the ruling, it provided more substantive information our Council was better placed to consider the advertising claims that had prompted the complaints.”
The European Traditional Herbal Medicinal Products Directive (THMPD) – in place since May 2011 – requires each EU member state to set up a traditional herbal registration scheme for traditional herbal medicines suitable for use without medical supervision.
In the UK this is the Traditional Herbal Registration (THR), managed by the Medicines and Healthcare products Regulatory Agency (MHRA).
To apply for Traditional Herbal Registration (THR) a company must submit:
- A technical dossier covering the quality of herbal ingredients.
- A review of safety with an expert report including clinical and non-clinical safety areas carried out by either a registered doctor, pharmacist, a herbal practitioner who is a member of a professional body or a scientifically qualified individual like a toxicologist.
- A draft summary of product characteristics according to the European Commission’s guidelines.
- A mock-up label and patient information leaflet in line with best practice guidelines.
The ruling against Omega Pharma has been reissued with a significant U-turn on the previous accusations of irresponsible advertising.
“We understood from the MHRA that the product was considered suitable for general sale without the intervention of a healthcare professional and that it could be advertised as traditionally used for treatment of lower urinary tract symptoms (within the terms of the licensed condition) without a requirement to seek prior diagnosis from a healthcare professional,” the ASA wrote in the updated ruling published today.
“We understood that the product labelling and leaflet provided safeguards to promote safe use; in this case, warnings to seek advice from a healthcare professional should symptoms worsen after seven days of use or persist after four weeks of use or if ‘red flag’ symptoms that may suggest a more serious condition were present.”
Wilson said the ASA, widely attacked for interpreting the NHCR too rigidly, saw the independent review process as an "important part" of its governance.
"It provides advertisers and complainants (who were party to the original complaint/investigation) with an opportunity to challenge our decisions where there appears to be a flaw in our procedures. It is only right that, where our Council is presented with persuasive arguments and evidence, we are prepared to overturn our original ruling and put that on the public record."
Ireland-headquartered pharma firm Perrigo, which acquired Omega Pharma in 2015 for €3.8bn, told us it was pleased the ruling had been reversed given it “strives to provide clear and responsible messaging for every product in the portfolio”.
Million dollar claim
However, it added it was “disappointed” with the decision to stick by a separate objection to the company's claim the product was used buy 10 million people.
Urostemol, which contains extracts of pumpkin seed and saw palmetto fruit, was marketing between the years 1996 and 2014 under the name Granufink.
During this time the company says it sold over 21 million units.
As a result of this rebrand, Perrigo used factory production volumes and consumer data to extrapolate that over 13 million people in Germany have used this product over the last 50 years under its different brand names.
The ASA panned this calculation, however, and stuck by its original assertion that the figure was misleading.
A male medical taboo
Perrigo said it would revise existing communication to ensure all information was suitably clear and “take these learnings on board” in future marketing.
“We would like to reassure Perrigo customers that our intention is to never mislead in any of our brand communications. [Male bladder weakness] is an issue that is not really being widely discussed, and our ambition was to offer a sympathetic message to consumers.
"Our goal is always to inform and educate people on the variety of evidence based self-treatment options available, which can support people who suffer from an overactive bladder. We also strive to ensure that people are equipped with all the information they need to seek further medical advice where necessary."
