Personal Injury Law

Why the EU banned Avandia but the FDA Didn't

Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That's when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.
Those being: GlaxoSmithKline (GSK), the drug's manufacturer, can't promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can't prescribe Avandia to new patients without explaining in detail why it might be more likely to cause a heart attack than other options. The FDA basically mandated everything short of putting a skull and crossbones on the label. But here's the rub: The European Union's European Medicines Agency dispensed with the subtleties and outright banned Avandia from being sold. Why didn't the FDA?

For more go here.  http://money.cnn.com/2010/09/24/news/companies/FDA_Avandia_GSK_ban.fortune/index.htm?section=money_latest&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+rss%252Fmoney_latest+%2528Latest+News%2529

Full post as published by A Georgia Lawyer on September 28, 2010 (boomark / email).