That U.S. Senate probe of GlaxoSmithKline and its diabetes drug Avandia may not yield any new regulatory action. But with more than 13,000 personal injury lawsuits outstanding, UBS analysts say, the company could be looking at a multibillion-dollar liability.
The safety of Avandia has been open to debate for almost three years now, and the Senate report didn't bring up anything entirely new about the drug's risks. The FDA already was planning to look at safety info on the diabetes med again, with a new advisory panel meeting on the schedule for this summer. The worries focus on a.) political pressure from the Congressional committee that sponsored the probe; and b.) those lawsuits.
"[O]ur concerns are solely on personal injury lawsuits," UBS analyst Gbola Amusa said. Experts polled by UBS put the potential liability at anywhere from $1 billion to $6 billion; the bank itself expects something less than $3.5 billion. "Bellwether trials start from 1 June and will help narrow our liability range," Amusa also notes.
- see the story in the Guardian