No New FDA Approvals Today!

FDA Website today (click for larger image)

FDA website today (click for larger image)

Obviously, with the Federal government in shut down mode, a situation precipitated by the House of Representatives’ demand to delay the implementation of the already-implemented Affordable Care Act (a.k.a. Obamacare), no new device approvals will be forthcoming today, or any other day, until the U.S. Government gets an infusion of start-up capital (puns intended).

Maybe a Kickstarter campaign would be in order here.

Another casualty of this impasse is the hope for repeal of the Medical Device Tax, a 2.3% tax on devices like artificial hips, stents, etc. that many Republicans, as well as liberal-left Democrats from device-company-centric states such as Minnesota and Massachusetts, have been lobbying for. But the attachment of a demand for repeal of this tax to the ultimatum of shutting the government down has, for the moment anyway, negated the support of the Democratic advocates for repeal, such as Amy Klobuchar, Al Franken, Elizabeth Warren et al (read Kevin Diaz’s article in the Minneapolis Star Tribune for more on this from a local perspective).

Meanwhile, several of the state Affordable Healthcare Act exchanges have also been sporadically shut down throughout the day, not for lack of funding. Quite the opposite: the traffic surge of people wanting to register and get an insurance plan has been so intense that many servers have been overwhelmed.

It’s a reverse Denial-of-Service attack. It’s a Request for Service attack.

 

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