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UK's MHRA reveals advertising lapses

Regulatory agency upholds complaints about iMed Systems, Genus and Lloyds

MHRAThe UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has published the results of its latest investigations into the advertising of medicines, upholding complaints made about iMed Systems, Genus and Lloyds.

iMed Systems promotes allergy treatment
The first complaint upheld by the UK regulator covers a complaint made by Meda Pharmaceuticals and ALK Abello about iMed's promotion of its injectable pen for allergies Emerade at a British Society for Allergy & Clinical Immunology meeting. 

The complainants alleged that materials displayed made several misleading claims, relating to compliance with guidelines, shelf-life, ease of use and the design of the product, storage instructions and checks before use, and incorrect instructions on a patient trainer device.

MHRA upheld the complaint, finding that the claims relating to guideline compliance were misleading and the instructions on the trainer device were not consistent with the product SPC.  

iMed Systems Limited agreed to withdraw all UK promotional materials for the product and to amend claims in future material for better clarity. The pens have been embargoed until a variation to the SPC is completed.  

Lloyds Pharmacy promotes Viagra to public
The MHRA also upheld a complaint made by a member of the public who claimed that Lloyds Pharmacy had allegedly promoted Pfizer's Viagra (sildenafil), a prescription-only drug for erectile dysfunction, to the public. 

Lloyds said that an email had been unintentionally sent to customers who had previously ordered various medicines indicated for erectile dysfunction.  Future announcements of this type will go only to those who have previously received the medicine named, Lloyds agreed.

Genus Pharmaceuticals missing mandatory text in advertisement
In a review of advertisements from healthcare companies in healthcare professional journals, the MHRA determined that an advert from Genus Pharmaceuticals did not include a message linking the use to find more information about the product on a relevant website.

As such, Genus has agreed for all future advertisements in journals to include the statutory wording set out in regulation 295 of the Human Medicines Regulations 2012.

This is: 'Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: [URL of website].' 

Buscopan complaint not upheld
One complaint not upheld by the MHRA was one made against Boehringer Ingelheim failing to mention in a TV advertisement that its drug Buscopan IBS Relief should be used only after a GP diagnosis of IBS

The MHRA refuted this, however, noting that the statement “For medically confirmed IBS” was displayed during the advertisement, appearing on screen long enough to be readable by the viewer.

17th September 2013

From: Marketing, Regulatory

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