GSK, Astellas and Novartis warned over drug promotions

If the report that the special relationship ended between the US and UK wasn't enough, the US Food and Drug administration (FDA) has sent disapproving letters to the European pharma giants GlaxoSmithKline (GSK), Astellas and Novartis over the apparent violation of certain rules.

The specifics of the letters from the FDA boil down to GSK placing an advertisement in a journal that fails to reveal any of the risks associated with its new leukaemia drug Arzerra (ofatumumab), essentially implying that the drug is safer than has been demonstrated by substantial evidence or substantial clinical experience.

FDA sends damning letter to GSK

Furthermore, the FDA’s letter to GSK notes that while information in the product labelling states that the "effectiveness of Arzerra is based on the demonstration of durable objective responses. No data demonstrates an improvement in disease related symptoms or increased survival with Arzerra", according to PharmaTimes. The main gripe for the FDA was that the ad completely omitted important information and so suggests that the drug is more effective than the evidence shows.

The FDA also cited GSK's incompetence during the pre-approval review period, claiming the UK pharma giant didn't submit the ad for regulatory consideration. The FDA regulations stipulate that copies of all promotional materials intended for publication are submitted within 120 days of marketing approval. Arzerra was approved on October 26, 2009, while the ad in question was published in the Journal of Clinical Oncology on December 1.

In another complaint about false efficiency, the FDA sent a letter to Astallas Pharma and partner GSK, citing a web-page promoting the bladder control drug Vesicare (solifenacin succinate) was "false or misleading because it presents unsubstantiated superiority claims and overstates [its] efficacy."

The FDA suggested that the web-page misguidedly suggests that Vecicare is superior to Pfizer's overactive bladder treatment Detrol, even though the trials to support Astallas Pharma's claims are largely untrue.

Rather tellingly, in response to the letters, GSK has removed the misleading information from the Vesicare website, and said it will not use the Arzerra ad again, company spokeswoman Mary Anne Rhyne said, according to Reuters.

Novartis not immune to critism

Novartis, the Swiss pharmaceutical giant has also been warned over an email it sent to consumers that, according to the FDA, is "false or misleading" because it minimises risks associated with the use of Voltaren Gel, whilst overstating its drug efficacy.

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