I've attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It's true I'm no expert, but recent hearings for medical devices have gone in a direction that strikes me as odd. For instance, at the Jan. 11 meeting of the gastroenterology/urology devices committee, FDA's Herb Lerner, MD, addressed post-market study requirements for an application filed by Torax Medical of St. Paul, Minnesota. Among the items of discussion that day were quality-of-life scores for gastroesophageal reflux and measures of esophageal pH. Lerner said: “This is a very interesting...

The Obama administration has published its budget proposal for fiscal year 2013 and the proposal includes a drop in appropriated funds of $4 million for FDA's Center for Devices and Radiological Health. As expected, the budget also calls for cuts to Medicare that could have an effect on makers of imaging equipment and durable medical equipment as well, giving device makers an incentive to turn out in force on Capitol Hill to blunt the damage in any spending bills Congress might draft.

There are many definitions for the word “crazy,” and here's another. Crazy is when you want to get out of Medicare and save the government and the taxpayer money, but the government won't let you. Recent reports indicate that a group of five senior citizens, including former Texas Republican congressman Dick Armey, are okay with their Social Security benefits, but that the law is forcing them to enroll in Medicare Part A if they want to stay on Social Security. The case made it to the Court of Appeals for the District...