Why are there differences in FDA and EU regulatory viewpoints?

Last week the FDA reviewed and rescinded support for Avastin for breast cancer. At the same time, the EU regulators expanded support by approving Avastin's use first line with the chemotherapy agent Xeloda. Interestingly, there are quite few US patients on this same combination who report success.

In June of this year, France and Germany rescinded support for Actos and the EU version of Actoplus Met based on the reports of increased risk for bladder cancer. The US regulators added a warning for increased risk for bladder cancer for those taking Actos, Actoplus Met and Duetact for more than 1 year. But the FDA has not moved to rescind support of Actos or its combos here in the US, yet. That might change now that the ADA reported in San Diego last week that Actos and Avandia both show an increased occurance of macular edema.

And the EU pulled Avandia while the FDA restricted its use but did not ban it.

J&J's blood thinner Xarelto just won FDA approval in a pretty long battle while the drug has been used in the EU since 2008.

There are plenty more differences in both biologics and devices. In our data, we see patients experiencing the same benefits and concerns regardless of geography. Patients stories paint a more global viewpoint than it seems the regulators do and are typically confused as to why a drug is banned on one continent but available in another.

I certainly want the FDA to take its time and use solid data when they approve or ban products but it seems that perhaps data, experiences, and criteria could be shared more across regulatory bodies. The manufacturers are global as are patient experiences.






So, why do these regulators differ.