Taxes are everywhere, but device makers are still exercised over the 2.3% excise tax on their offerings. Corporate tax reform, too, looms as a policy issue in our nation's capitol, but what are the odds Congress will pass and the President will sign legislation dealing with either of them? A quick read of the tea leaves, as it were, suggests the odds are not very good. Klobuchar; corporate tax reform on the rocks Sen. Amy Klobuchar, no novice where the device tax is concerned, appeared at last week's...

If someone is blowing smoke up your butt today, it probably means they are feeding your ego with insincere compliments. But a few hundred years ago people literally blew smoke up other peoples’ keisters for a variety of medicinal purposes. This was the enlightening takeaway from a recent visit with my GI surgeon, Julius Bonello of Peoria, Illinois. Bonello wrote an article published in the December/January issue of History Magazine detailing the medical history of tobacco and an apparatus used to literally blow...

Device makers are by now quite aware that FDA-inspected firms have 15 working days to respond to an inspectional form 483, but is this always consistently applied? It would appear not. Whether that difference makes a difference in the issuance of warning letters is tough to know, but one might think there are reasons for misgivings. An example of when FDA is lenient (and I assure the reader this is not the only such case) is the Dec. 9, 2014, warning letter to...

The Las Vegas casinos were teeming with activity last week, but the true bets from orthopedic surgeons who descended upon the city during the American Academy of Orthopedic Surgeons (AAOS) weren’t originating from the tables in their hotel lobbies. Smart money was being placed on what would happen regarding the Sustainable Growth Rate (SGR). Ultimately the House would overwhelmingly pass the bill. But the Senate went into recess before making a final vote. For the uninitiated, in 1997, Congress adopted the SGR formula as part of the Balanced Budget Act. The idea was to control federal health care spending....

The Las Vegas casinos were teeming with activity last week, but the true bets from orthopedic surgeons who descended upon sin city during the American Academy of Orthopedic Surgeons (AAOS) weren’t originating from the tables in their hotel lobbies. True bets were being placed on what would happen regarding the Sustainable Growth Rate (SGR). Ultimately the House would overwhelmingly pass the bill. But the Senate went into recess before making a final vote. For the uninitiated, in 1997, Congress adopted the SGR formula as part of the Balanced Budget Act. The idea was to control federal health care spending. The...

From time to time, it's nice to rediscover I'm not the only cynic in the room. So I was obviously relieved to see a couple of criticisms of the latest orthodoxy about the future practice of medicine. The question is: Is the Precision Medicine Initiative the real deal or just another government gamble on the ponies? Goldilocks syndrome Rita Rubin writes in the March 17 issue of the Journal of the American Medical Association that the hyperbole surrounding the President's Precision Medicine Initiative (or PMI) has raised a...

As those in attendance at ACC 2015 know, Jeff Popma of Beth Israel Deaconess asked publicly whether the 30-day data for Sapien 3 should suffice for approval of the device, but the story grew more interesting today (March 16). I was at a session at ACC dealing with translation of research into clinical practice, and Bram Zuckerman, director of the cardiovascular devices division at FDA’s Office of Device Evaluation, was on the dais. He talked a little about how FDA approaches evidence and so on, and really had little to say that he hasn’t said many times before. Someone in...

Earlier this month, I had the distinct pleasure of having a sit-down interview with Kenneth Mandato, the lead researcher for the migraine study and an interventional radiologist at Albany medical center, during the Society of Interventional Radiologists Annual meeting held here in Atlanta. During the interview we discussed the prevalence of migraines and a rather old (but underutilized) technique to treat these conditions. Mandato and a team of researchers from Albany Medical Center and the State University New York Empire State College (Saratoga Springs, New York), used a technique called image-guided intranasal sphenopalatine ganglion (SPG) blocks to give patients...

You don’t see it very much these days – bipartisanship. Yes, federal legislators on both sides of the political spectrum actually agree on something. This time they concur that the medical device tax, one of several funding mechanisms for the Affordable Care Act (ACA), has got to go. They argue that the tax stifles innovation and employment in the medical device industry. Medical device companies will more likely pay this tax by withholding some investments in research and development and their workforce, rather than passing the...

There are facts and there’s the stuff that surfaces when facts are in short supply, but as Groucho Marx might have said, facts goes out your front door and rumors come innuendo. Following are three developments that have emerged over the past two months, but just what do we really know about all these goings-on? Who’s next at FDA? It was hard to be in the life science business and not hear about FDA commissioner Margaret Hamburg’s plan to leave the agency by the end of this month, and the news sparked a...