Product News and Recalls

GSK CEO addresses company’s fraud allegations

In an interview with reporters, GlaxoSmithKline chief executive officer Andrew Witty addressed the record $3 billion in penalties recently assessed against his company – including the question of whether jail time for company executives might be appropriate in such cases.

In a blog entry about the interview, the Philadelphia Inquirer’s David Sell mentions that Witty became CEO in May 2008, which is after the criminal conduct involved in the plea agreement. The GSK board of directors was aware of the investigation when they chose Witty to replace Jean-Pierre Garnier.

As part of the largest settlement ever leveled against a pharmaceutical company, GlaxoSmithKline recently agreed to pay $3 billion in fines for fraudulently promoting medications for unapproved uses.

The settlement doesn’t end the company’s legal troubles. Widespread lawsuits allege that GlaxoSmithKline and other manufacturers of antidepressants classified as selective serotonin reuptake inhibitors failed to adequately warn pregnant patients of studies linking the drugs to potentially dangerous heart and lung defects in newborns. SSRI antidepressants include Prozac and Zoloft.

GSK was charged with illegally marketing various medications for off-label uses, through tactics that included paying kickbacks to doctors and misrepresenting research data. Although prescribing a drug for a purpose different from the use specified in its U.S. Food and Drug Administration approval is legal, promoting drugs for off-label use is not.

The story quotes Witty as saying: “The question of how people get punished or how entities get punished is a big question. It goes far beyond the drug industry and is for others to think about. I can absolutely answer you that I don’t think it would have made any difference to the seriousness with which this organization has dealt with and reacted to the issues brought to our attention.”

Sell mentions that many industry critics have questioned whether even sanctions the magnitude of the recent settlement will dissuade companies from illegal actions, in light of the fact that GSK still made a profit off the drugs in question.

He quotes Dan Levinson, the Inspector General of U.S. Department of Health & Human Services, as saying: “We are concerned that these providers may consider engaging in fraud schemes, and paying civil penalties and criminal fines if caught, as a cost of doing business.”

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries from SSRIs.

See the report here:

http://www.philly.com/philly/blogs/phillypharma/163747956.html