GlaxoSmithKline, Astellas and Novartis have been sent warning letters by the US Food and Drug Administration over violating rules that govern the promotion of medicines across the Atlantic.

The world’s second largest drugmaker stands accused of placing an advertisement in a journal that fails to reveal any of the risks associated with its new leukaemia drug Arzerra (ofatumumab), and therefore indicates that the drug is safer than has been demonstrated by substantial evidence or substantial clinical experience.

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 demonstrate an improvement in disease related symptoms or increased survival with Arzerra”, the ad completely omits this important limitation, and so suggests that the drug is more effective than the evidence shows.

In addition, the regulator also slapped GSK on the wrist for failing to submit the ad for regulatory consideration during the drug’s preapproval review period. For biologics such as Arzerra, FDA regulations require that copies of all promotional materials intended for publication within 120 days of marketing approval are also submitted for review. 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 letter, sent to Astallas Pharma and partner GSK, the regulator said a webpage promoting the bladder control drug Vesicare (solifenacin succinate) is “false or misleading because it presents unsubstantiated superiority claims and overstates [its] efficacy”.

For instance, the webpage misleadingly suggests that Vesicare is superior to Pfizer's overactive bladder treatment Detrol (tolterodine), even though the necessary trials to support such a claim - as well as those relating to efficacy, such as that that a greater percentage of patients treated with Vesicare had no incontinence episodes or were drier at 12 weeks than those given a placebo - have not been carried out.

Thus, the webpage misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations, the regulator warned.

In response to the letters, GSK has reportedly 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 email 'misleading'
Swiss pharmaceutical giant Novartis has also been warned over an email it sent to consumers that, according to the agency, is “false or misleading” because it minimises risks associated with the use of Voltaren Gel, overstates its efficacy of broadens its indication.

The FDA notes that the email “prominently presents efficacy claims in large bolded font size and in colourful text and graphics surrounded by a significant amount of white space,” while, in contrast, “the risk information is relegated to the bottom of the email and is presented below the indication for use in extremely small black font, and in single-spaced paragraph format that makes the information very difficult to read”.

Furthermore, while efficacy claims for Voltaren Gel are presented in language that is easily understandable to consumers, risk data is comprised of complex medical terminology that is “not likely to be comprehended by the same audience”, the regulator said, and concluded that, the way the email is presented overall “undermines the communication of important risk information, minimising the risks associated with Voltaren Gel, and misleadingly suggesting that Voltaren Gel is safer than has been demonstrated”.

Novartis said it is reviewing the FDA’s letter and plans to with the regulator to address its concerns, according to media reports.