FDA Fines Glaxo
On July 2, 2012 the news reports started coming out about the FDA fining GlaxoSmithKline (GSK, or Glaxo) $3 billion for incorrectly promoting Paxil and Wellbutrin (2 of 10 drugs total), and for failing to report all the safety data required by the FDA on Avandia (such as potential heart problems caused by it). The fines cover criminal fines as well as civil settlements with federal and state governments.
This was for occurrences between 1998 and 2003 for Paxil and Wellbutrin, and 2001 and 2007 for the diabetes drug Avandia.
Paxil was promoted as a medication that could be used in patients younger than 18 (despite the increased risk for suicide), and physicians were taken on “seminars” to Hawaii, Puerto Rico etc. in order to learn more about its use (i.e. taken on vacation junkets, with very little purpose for ‘learning’.)
Although drug companies must label medications approved by the FDA only for those purposes it was investigated for use of, physicians do not have to stick with this and can use it for ‘off-label’ purposes. Many of which they appear to learn of through pharmaceutical sales staff who have financial incentive to meet quotas for sales.
As part of the agreement, the reimbursement for sales staff has been changed, and Glaxo will be monitored for practices for 5 years.
Resources: The Telegraph
