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FDA Really "Buries Lead" on Glaxo Drug Promotion Warning

Tuesday, 27 Nov 2007 | 10:01 AM ET

Late yesterday, a bullet crossed the Dow Jones newswire saying, "FDA Warns GlaxoSmithKline on Breast-Cancer Drug Promotion." Almost immediately, my producer and I got a call from the CNBC staffer who was manning what we call our "Alerts Desk" asking us if we'd seen the news and if we could provide any context. We started digging, checking out the Glaxo and FDA web sites and placing calls to our GSK and FDA contacts.

In the meantime, I persisted in looking for the so-called "Warning Letter" on the FDA's web site. I tried clicking on "Warning Letters." Nope, not there. Tried going into the "FDA Newsroom" and then clicking on "Warning Letters." Nope, not there either. I kept clicking on this and that, "Recalls/Product Safety," "Warning Letters and Response," "Warning Letters," "Press," etc. Nothing. It took me a good 15 minutes or so to counterintuitively find the news.

First I had to click on "FDA Newsroom", then "What's New by Topic," then at the very bottom of that list I found the link to "Warning Letter: Tykerb" and finally had to click on "TYKERB (lapatinib) Tablets" to find the buried treasure. I'll save you the trouble with this link to the rather strongly-worded communication to GSK CEO JP Garnier.

The FDA takes Glaxo to task over the letters it sent or handed out to healthcare professionals during the launch of its pill for breast cancer, Tykerb (pronounced tie-curb). The agency says the letters were "misleading in that they omit and minimize the most serious and important risk information…and selectively present efficacy information…thereby overstating the efficacy…." The FDA goes on to say, "We are particularly concerned that these materials…suggest to healthcare professionals that Tykerb is safer and more effective than has been demonstrated." The letter finishes by telling Glaxo to not only rectify the problem, but to tell the FDA how it will do better in the future or else.

All of this takes place against the backdrop of Glaxo still trying to navigate its way around the Avandia safety controversy where allegations have been made that GSK tried to hush a whistleblower. A spokesperson sent us this brief statement in response to the warning letter via email, "GSK takes seriously the concerns outlined in the FDA letter and we will work with the agency to address its concerns. Providing healthcare professionals with complete and accurate information on the safety and efficacy of all products, including Tykerb, is a top priority."

In the not-too-distant past I recall being asked to fill out a survey for reporters about the user-friendliness of the FDA web site. I think I submitted it. Regardless, this is a perfect example of the improvements that still need to be made to the cluttered site (just take a look at the homepage www.fda.gov), especially in the current environment where the agency is presumably trying to show the public it is "on duty" as a watchdog.

Questions? Comments? Pharma@cnbc.com

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