No doubt some are tired of hearing me go on about the FDA budget, but industry thinks the agency is under-funded, too. Most who are part of this discussion believe FDA would be more functional with appropriate appropriations, but they ignore the dynamic necessary to fully fund FDA. Hence, the dysfunction persists. To wit: Dealing with FDA’s public affairs staff is typically not a bad experience unless they have to consult with others at the agency on fairly detailed matters. For instance, I’d written last year about a Federal Register notice addressing pre-emption of state law with regard to the...

In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current state of affairs. In fact, it appears that this once proud and successful domestic industry is on life support. Perhaps the most credible criticism came from Tom Fogarty, a legendary entrepreneur in the medical device field. In a story written by Senior Staff Writer Amanda Pedersen, Fogarty asserted that “it’s reached a point in the field of medicine that we in the U.S. are no longer...

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...

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...

Hopefully not lost in all the comings and goings of more than 8,500 people at the J.P. Morgan Healthcare Conference in San Francisco last week were some important take-home messages about the future of med-tech, a future that promises many challenges for the industry, but also many rewards for those willing to follow promising trends. 1. Healthcare Information Technology is going to be big this year and probably into the foreseeable future. This is the final year in which hospitals and physicians can demonstrate meaningful use and get maximum healthcare dollars under the stimulus, so there should probably be some clarification...

As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the industries it regulates. Opinions about FDA ranged from awful to terrible, and doctors and industry fared no better. It seems a lot of people think user fees conscript FDA, and some see the agency, industry and physicians as some sort of malevolent troika that would have made the Kremlin of Leonid Brezhnev proud. Maybe I'm too close to it...

Forgive me for ripping off Dickens, but a good headline is priceless. This posting, however, is about two tales of an agency (located near Washington) with which we are all familiar. For the first tale, FDA recently re-classified diagnostics for the Yersinia genus of bacteria (Bubonic plague, just in case you were wondering) as covered in the Nov. 18 edition of Medical Device Daily, and FDA stated in the Nov. 17 edition of the Federal Register that an advisory committee had recommended such a change back in 2002. This is not the only example of a request for a device...

Long-time observers of FDA's regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed the other way. The only question is how far. It's not tough to find parties that have a hand in this. Congress finds it difficult to keep a steady hand because there are two parties with their different worldviews. Ditto those in the executive branch. Perhaps there is an inevitability to the back-and-forth at FDA's Center for Devices and...

I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib....

By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group Cook Medical's Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies. I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had...