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MHRA cuts fudged ads

Misleading promotional material withdrawn after MHRA intervenes

Two pharma companies have withdrawn marketing material following a clampdown by the Medicines and Healthcare products Regulatory Agency (MHRA) on drug advertising that may mislead health professionals.

In one case, the MHRA upheld a complaint, raised by Vitaline Pharmaceuticals in November 2005, against Syner-Med (Pharmaceutical Products) Ltd regarding two promotional brochures for anaemia treatment Venofer (intravenous iron sucrose).

The marketing material was deemed to be misleading, ìin that it failed to make clearî the potential of the product to cause allergic or other serious adverse reactions. ìThe brochure also failed to include important messages about the safe administration of the product,î the MHRA said in a statement.

Reacting to the events, Syner-Med withdrew the offending material and agreed to issue a corrective statement. ìSyner-Med (Pharmaceutical Products) Ltd would like to express regret. The company takes concerns regarding public health matters very seriously and duly apologises for the shortcomings of this communication.î

The MHRA told Pharmaceutical Marketing that the source of marketing-related complaints is ìusuallyî healthcare professionals; it is less usual for companies to issue complaints about other companies' marketing information.

In a second case, revelations arising from the MHRA's routine checking procedures resulted in it taking action against Belgium-based bio-pharma firm UCB Pharma, which resulted in the withdrawal of an ad and promotional material for Kentera (oxybutynin), its skin patch to control the symptoms of urge incontinence.

The agency notified via its website that the company's advert ìsuggested that the side effect of dry mouth was less prominent than in other comparable productsî, and intervened on the discovery that UCB's Summary of Product Characteristics did not support this claim.

The MHRA is especially keen to be seen tackling misleading promotion, alongside the ABPI's refreshed 'no-nonsense' stance.

ìThe MHRA will not tolerate medicines advertising that creates unrealistic expectations in prescribers and patients, or is misleading,î said senior policy manager, Jeremy Mean.

30th September 2008

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