Donald Berwick's tenure at the Center for Medicare & Medicaid Services was brief, but should come as no shock to anyone who knows how the former physician came to the job. What's stunning is how many believe the Obama administration and House and Senate Democrats bear no responsibility for the brevity of his stint at CMS. Let's take things in chronological order. First, President Obama and Democrats in Congress drafted what is probably the largest piece of legislation ever to pass without any input from the legislative minority. They then rammed the vote through Congress with only feeble support...

GAITHERSBURG, Maryland Protocol violations are not unheard of in pivotal device trials, but the trial for the CardioMEMS (Atlanta) Champion heart monitoring system was badly violated by FDA's reckoning thanks to communication from the sponsor to study sites. However, the FDA circulatory systems advisory committee voted that the risk-benefit dynamic was not supported for the diagnostic as much because of concerns that real-world use of the device would not match the way the Champion diagnostic was utilized in the pivotal trial, rendering a 6-4 vote that the risk-benefit profile did not measure up.