Posted 12 February 2016
By Zachary Brennan
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday said it has reprimanded the dermatology company Galderma after receiving an anonymous complaint about promotional material for a prescription drug shared on the social networking site LinkedIn.
MHRA said it upheld the complaint as the UK, unlike the US, does not allow prescription-only medicines to be promoted to the public though it does allow advertisements for over-the-counter medicines, according to guidance.
Switzerland-based Galderma assured MHRA that the material was a single employee’s error of judgement outside of the company’s knowledge or authority. The company provided details of remedial action to ensure all of its staff are aware of company policy on the use of social media.
MHRA on Friday also announced that 10 UK clinics advertising botulinum toxin products amended their advertising to ensure prescription drugs are not advertised to the public. Earlier last month, the regulator also upheld a complaint about a letter from Fontus Health to Cambridgeshire and Peterborough Clinical Commissioning Groups about Zaluron XL (quetiapine), saying that the material was promotional as it contained product claims and was aimed at persons qualified to prescribe or supply medicines and should therefore have included statutory information.
But the regulator denied a separate complaint in which Rosemont Pharmaceuticals said a leaflet for omeprazole suspensions issued by RENA Specials Limited in March 2015 promoted unlicensed medicines and referenced a tariff which was out of date. MHRA said the material did not constitute an advertisement under the Human Medicines Regulations 2012 as it was only shared with some specialty manufacturers for business development purposes and the tariff was correct at the time of issue.
Last February, MHRA released a report on advertising complaints, noting that there were 193 complaints about online advertisements in 2014, down from 237 in 2013.
Regulators and the Web
Regulators seem to be looking more consistently at social media to find pharmaceutical marketing practices that do not meet their standards. The US Food and Drug Administration previously issued a warning letter for comments made on Facebook, Twitter and Pinterest. FDA has been embroiled in a debate with industry and the courts over what should be considered free speech and what should be considered off-label marketing, with at least one expert thinking the issue could head to the US Supreme Court.
MHRA also collaborated with the European Monitoring Centre for Drugs and Drug Addiction in a new report on the Internet and drugs (illicit and prescription). The report notes that the legal position surrounding the online supply of medicines varies across the EU, with some countries, such as the UK and Germany, allowing all classes of medicines (prescription and OTC medicines) to be sold online, while others allow only OTC medicines, and some, such as Italy, prohibit the supply of all medicines online.
As far as advertising online in the EU, the report notes that it “is not permitted anywhere” and any Web advertising of prescription medicines is in breach of legislative requirements and action can be taken to remove the website.
MHRA Blue Guide: Advertising and promoting medicines
Advertising complaint form