Glaxo To Pay Feds $400 Million Over Off-Label Marketing Of Wellbutrin SR, Possibly Paxil And 7 Other Drugs

The Wall Street Journal's Health Blog is reporting that GlaxoSmithKline has set aside $400 million in its fourth quarter of 2008 to answer a federal inquiry into off-label marketing of nine unnamed drugs. The inquiry was led by the US Attorney's Office in Colorado. In a statement the company said:

"GlaxoSmithKline plc (GSK) today announced that it will record a legal charge in the fourth quarter of 2008 of $400 million (£278 million) relating to an ongoing investigation initiated by the US Attorney’s Office in Colorado into the Group’s US marketing and promotional practices for several products for the period 1997 to 2004."

Technically, the company is merely setting aside the monies to reflect the current status of the inquiry, but companies like GSK don't set aside monies they don't reasonably expect to pay out or their shareholders would be very testy.

It's not clear what the nine drugs are, but the Journal provided a smart clue. From Note 44 of Glaxo's most recent annual report (page 156 of the 2007 annual report. Thanks to the WSJ Health blog for the link, but don't press it unless you want to wait a long time for all of the pages to load):

"In February 2004, the Group received a subpoena from the US Attorney’s office in Colorado regarding the Group’s sales and promotional practices relating to nine of its largest selling products, for the period from January 1997 to the present. In particular, the government has inquired about alleged promotion of these drugs for off-label uses as well as Group sponsored continuing medical education programmes, other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment. Although the original subpoena was issued from the US Attorney’s office in Colorado, the scope of the inquiry is nationwide. The government is also inquiring about the Group’s response to an October 2002 letter from the FDA’s Division of Drug Marketing, Advertising and Communication requesting information on the Group’s alleged promotion of Wellbutrin SR for off-label use. The Group is co-operating with the investigation and providing the requested information."

Obviously, there is some connection between the $400 million charge and Wellbutrin SR, but I've got only a slim idea of what the other eight products might be. You could of course reasonably suspect that Paxil will be one of them, given that the company was aggressively marketing the still-on-patent drug in the late-1990s.