Play nice. That would be my advice for both the European Commission's health and consumers department and FDA. And it hasn't typically been a problem. But EC officials were miffed after CDRH director Jeffrey Shuren made some opaque remarks about the safety of medical devices in the United States vs. the European Union. Devices reach the market faster in Europe, but Shuren has repeatedly said or implied that safety problems are harder to detect in such a system. During a conference call last month, Shuren went a little further and said that the EU system used the public as guinea pigs. Zing!

These comments eventually reached our neighbors across the Atlantic, and Paola Testori Coggi, head of the European Commission's health and consumers department, was understandably taken aback.

"I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way," Coggi wrote in a February 18 letter to FDA commissioner Margaret Hamburg.

But my favorite part of the letter is here: Coggi says that if FDA has evidence of unsafe devices on sale in Europe, "I would appreciate if you could share this information with European regulators." Zing back! Okay, maybe that was a serious comment (not convinced, are you?). 

An FDA spokeswoman tried to clear the air by saying U.S. and European regulators "continue to have a very collaborative relationship" that has "benefited both of us quite well for many years." How many more years will that last with comments like Shuren's? —Lawrence Lloyd