Healthy Skepticism Library item: 17648

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Those FDA Warning Letters To Glaxo & Novartis
Pharmalot 2010 Apr 19
http://www.pharmalot.com/2010/04/those-fda-warning-letters-to-glaxo-novartis/

Full text:

For those tracking the missives sent by the agency to drugmakers, here is a quick round-up of letters that were posted late last week on the FDA web site. Interestingly, two of the violations involve a web page and an email. GlaxoSmithKline was tagged for placing an ad in the Dec. 1, 2009, issue of the Journal of Clinical Oncology that was cited for being false and misleading for omitting safety and effectiveness info about Arzerra (here’s the letter and here’s the ad).
In another letter, sent to Astallas Pharma and Glaxo, which have a partnership to promote the Vesicare bladder control drug, the FDA charged that a web site promotion is “false or misleading because it presents unsubstantiated superiority claims and overstates efficacy” (here’s the letter and the web page).
And Novartis was warned over an email sent to consumers that the FDA says minimized risks associated with the Voltaren Gel, overstates efficacy and broadened the indication. 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.” But the risk info 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” (the letter and the email).