I remember reruns of a cartoon about a character named Tooter Turtle, who was always appealing to Mr. Wizard to send him back in time for some form of jollies or other, and when the whole thing went south, Tooter would yell out, “help Mr. Wizarrrrrd!”
At which point, Mr. Wizard would cluck about the futility of it all in his central European accent and bring Tooter back with the incantation, "drizzle, drazzle, druzzle, drome; time for zis one to come home."
I never had any idea what that drizzle-drazzle stuff was all about, but it worked for Mr. Wizard. Maybe it was because he had that charming, casually elitist Habsburg dynasty thing going on (The peasants are revolting but you're not so bad when you make an effort, dahhhhling). Who was I to argue?
By the way, please don't write me nasty letters about the Wayback machine being an invention by Mr. Peabody, paleo-techno-geek and friend to Rocky and Bullwinkle. I'm taking liberties here. I'll be more circumspect when they start flying me around in corporate jets.Without too much more ado, here is a glimpse into the med-tech past, courtesy of Medical Device Daily.
Inhalable insulin: Oh to believe again
Today I'm going back only as far as five years because at the rate of technological and policy developments in the world of medical devices, five years is way back, indeed.On this date, July 11, in 2006, Medical Device Daily ran a story on an agreement between Novo Nordisk (Bagsvaerd, Denmark) and Aradigm (Hayward, California) in which the latter sold patent rights to its technology related to glucose control. At that point in time, Nordisk was working on its inhalable insulin technology and agreed to pay Aradigm $27.5 million for the patented technology.
If you're thinking Aradigm got the better of the deal, you're probably right. Nordisk got into a patent fight with Pfizer (New York), maker of Exubera, in August that year and both firms' products were off the market in two years. There's a saying we have in the trade press about things like that, and it goes pretty much like this: Ouch.
Override this!: Bush threatens to veto MIPPAOn this date in 2008, Medical Device Daily reported that President George W. Bush had threatened to veto H.R. 6331, the Medicare Improvements for Patients and Providers Act of 2008, which among other things papered over a cut of more than 10% to Medicare Part B doc fees and tacked on a raise of about 1%.
According to govtrackus.com, the President did indeed slap a veto on the bill, which the the House and the Senate overrode the very same day, July 15. The House came up with 383 aye votes to only 41 nays while the Senate came up with 76 votes in the affirmative versus 24 votes to the contrary.
How can it be that the sustainable growth rate overhang has nearly tripled in just three years? Is this some kind of magical healthcare multiplier? FYI: The bill also put an end to competitive bidding for clinical lab services that bill to Medicare.
Perhaps the most remarkable thing about MIPPA is that it gave us something that rhymes with HIPAA, otherwise known as the Health Insurance Portability and Accountability Act of 1996. When I heard about MIPPA, I think I said something like, “HIPAA and MIPPA were on the wall. HIPAA fell off. Who was left?”
Attorney forecasts pushback from Capitol HillAnd from July 12, 2010, which is really, really close to this date last year (July 11, 2010 was a Sunday and we don't publish on Sundays), Medical Device Daily reported that Jeffery Gibbs of the law firm of Hyman Phelps & McNamara (Washington) talked about the tighter scrutiny of devices by FDA. Gibbs apparently asserted that the changes underway at FDA are more sweeping than the changes imposed by David Kessler, MD, who led the agency during a near total shutdown of the 510(k) pipeline in the 1990s.
Gibbs also said during a conference call that some firms in the U.S. “will not submit 510(k)s, they’ll scale back on plans and they’ll focus on operations overseas now,” which he said was “leaving a bad taste in some people’s mouths on [Capitol] Hill.” Gibbs said, “whether this will translate into concrete action from legislators is unknown.”Consider it known. The latest member of Congress to sit FDA down for a chat is Sen. John Kerry, but also on that list is Sen. Al Franken (D-Minnesota), he of Saturday Night Live fame and not exactly the kind of guy you'd characterize as a hack for industry, at least not when he was elected in 2008. Of course, he is from Minnesota, isn't he?
All the same, if you're working at FDA and Al Franken tells you you've gone overboard, you're either living in Bizarro World – a possibility I can't rule out when I'm watching “World's Dumbest” on the television – or you've just flat-out gone too far.What do I think industry is saying about all this congressional fuss and bother? Probably what Anthony Michael Hall said in the movie “Sixteen Candles” when the object of his lust had agreed to terms. “This … is getting good.”