Washington is such a fun town, replete as it is with smoke and mirrors. It appears that despite my earlier protests about the mixed-up priorities where NIH spending are concerned, our elected officials are aware of the coming deluge of costs associated with Alzheimer's disease, but the latest legislation to address this disease, the National Alzheimer's Project Act (which goes by the cheery acronym of NAPA for you fans of wine and/or auto parts stores) seems to do little other than coordinate federal and state resources. According to a fact sheet posted at the website for the Alzheimer's Association (AA;...
I’ve never given much thought as to how long I would live. When my time is up – it’s up. I would have assumed, however, that given the advances made in healthcare over the last several decades, that my generation will live longer than the ones before it. More than an assumption, actually, it’s common knowledge and easily confirmed by Centers for Disease Control and Prevention data. So I was very surprised to see a headline pop up in my inbox today telling me that life is getting shorter for women in hundreds of U.S. counties. Sure enough, a new...
Those with a keen eye trained on the patent reform bill now under consideration in the House of Representatives might universally hold a dim view of fee diversion even if they see first-to-file and the prior user defense through profoundly different lenses. The problem is that the manager's mark for H.R. 1249 as of June 20 includes language that will put the fees paid by patent, trademark and copyright applicants right back into the hands of appropriators, who will have a tough time avoiding the urge to raid the cookie jar in a fiscal environment in which cookies are increasingly...
The U.S. House of Representatives is expecting a vote this week on its patent reform bill, but unlike passage of the Senate bill, the House bill has to deal with a potentially crippling conflict. This conflict was set up by the provision dealing with fees collected by the Patent and Trademark Office, which is on a collision course with the budget-cutting mood in the House. Another difference between the two bills is the inclusion of the prior user defense in the House bill, but I'm going to propose that the real question here is not whether the House and Senate...
My little West Central Illinois town got hit with a thunderstorm a couple nights ago. Even though my 3-year-old son handles storms exceptionally well for his age, I decided around 2 a.m. I needed to peek in his room to make sure he was okay. To my surprise, I found him lying in bed awake. I asked if the storm was keeping him awake. “No. I’m sick,” he said. Sure enough, a quick touch of his forehead and cheeks told me he had a fever – and probably a rather high one at that. But to determine how bad it...
FDA's Center for Devices and Radiological Health published the results of its analysis of decisions on 510(k) applications between 2006 and 2010 (see the pdf of the report here), including some data from as far back as 2001, and several features jump out to the casual observer. The problem for CDRH managers is that the report suggest a number of stories – several of which the agency fails to tell – that will do nothing to dial down industry's pushback against FDA's more aggressive enforcement/compliance regime. The report is also certain to do nothing to drain the increased pressure on...
Last week, the Advanced Medical Technology Association (AdvaMed; Washington) put on its Superman cape and unveiled a set of policy recommendations that it hopes will preserve America's position as a leader in medical technology innovation. Dubbed the Competitiveness Agenda (which can be seen in more detail by clicking here), AdvaMed is issuing out a call to arms to the government to not overlook the med-tech industry. Here's the problem that the med-tech industry is facing. Imagine for one moment that you're on the brink of not being able to pay your mortgage. Slowly and steadily you're getting behind on the bills...
ReGen Biologics (Hackensack, New Jersey) has filed suit against FDA over the agency's rescission of the firm's Menaflex application, a slugfest that is certain to draw intense interest everywhere, from Capitol Hill to the boondocks of the medical device industry. This might be a lawsuit that wends its way quietly into history, but it could also rupture whatever cohesiveness there might be at the agency's Center for Devices and Radiological Health. At the very least, it will serve as a huge distraction for CDRH officials and impose yet more drag on operations...
Much to my annoyance, I’ve often been mistaken for being younger than my actual age. At 24 I could not buy a lottery ticket without being carded (even though 18 is the legal age for that in my state). A few years ago a 14-year-old neighbor girl spotted me in the front yard and asked what school I attended because she thought we were the same age. And just a few months ago my son and I both received a kids’ menu at Perkins when the hostess mistook me for 12 or under. And for as long as I can...
About three months into my wife's pregnancy with my daughter, something strange happened at the doctor's office. Not to my wife or the baby per se, but rather to the way her doctors kept records. Everything went electronic. No more notes with handwriting that even the clinician that jotted down said notes couldn’t understand. Instead scribblings that looked like hieroglyphics were crisp and clean to the eye. I was impressed. Here I was seeing the implementation of the very same thing I had been writing about these past few years. I said at the time that, truly doctors offices are...
RSS