The FDA medical device review mechanism has come under fire from many quarters for some time now, but one of the criticisms of the 510(k) and PMA programs is that the reviews are funded by user fees, a claim that can be made of pharmaceuticals, biotech and now even FDA’s overview of food production. Opponents can complain all they want about user fees, but what can they do about them? As has been widely reported, the Obama administration has proposed that FDA’s total budget for FY 2013 would rise by double-digit percentages, but 98% of that increase comes from...

By JIM STOMMEN Medical Device Daily Contributing Writer The recent decision by the Obama administration to propose big-time funding cuts for medical prevention and wellness programs is, like many of the decisions that come out of Washington, puzzling to say the least. Done as part of the extension of the payroll tax cut, the prevention/wellness cuts supposedly are the political quid pro quo for the lawmakers agreeing to maintain Medicare payments to physicians at existing levels for the remainder of this year — the so-called “Doc fix.” With a snip-snip here and a snip-snip there, seemingly worthwhile wellness efforts such...

The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...

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...

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...

It’s doubtful that Britney Spears’ 12-year-old hit single, Oops! . . . I did it again, entered into Roche’s mind when the firm disclosed a hostile takeover bid to acquire Illumina late last month for $44.50 a share in cash, or about $5.7 billion. Okay,  maybe doubtful isn’t the right word. Maybe I should say that there was no chance in the world that Roche even considered this song when describing its takeover bid. But to those who have followed Roche closely throughout the past few years, the song seems to fit Roche’s attempts to acquire the DNA sequencing company...

Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to examine the FDA whistleblower issue as a benchmark for drawn-out drama. As has been reported in Medical Device Daily, former FDA employees, including Robert C. Smith, MD, and Julian Nicholas, MD, were among the authors of letters to Congress and the Obama administration over alleged suppression of dissent over medical device approvals. Those letters came out in 2008 and...

The controversy over breast implants made with industrial-grade silicon has fanned out across the globe but it doesn't always seem as though the reaction and the facts jibe. There is a push in some nations to get women to have the implants made by Poly Implant Prothèse (PIP; La Seyne-sur-Mer, France), removed regardless of whether that woman has had a problem with her implants, but one question persists: Is the reaction proportional to the available data? The Jan. 12 news from Australia's Therapeutic Goods Administration is that...