Government-run health care: A glimpse of the future

Posted by Marc Hodak on March 26, 2010 under Government service | 3 Comments to Read

Boston Scientific, maker of those ultra-cool, implantable defibrillators, made some minor changes to the way they manufactured them.  There was nothing wrong with the devices under the old manufacturing method–they just felt that they could do better.  Unfortunately, the company ran afoul of the bewilderingly complex FDA documentation rules that require any manufacturing changes to be reported to them.  As a result, Boston Scientific has been forced to recall a bunch of perfectly good, life-saving devices, and submit their manufacturing changes for FDA review before being allowed to resume manufacturing.  FDA review times run from 8 to 30 days.

Boston-Scientific tried to calm their medical customers (and investors) by hinting that the urgency of this matter should warrant a shorter review period.  During this period, doctors are doing without the device (“Hang in there Charlie!  We’ll get that thing implanted in the next few weeks.”), and Boston-Scientific is losing $5 million a day.  If ever we needed those high-priced government services, this would be it, right?

FDA officials said in an interview that they have given Boston Scientific’s applications a preliminary look and the submissions appear to be in order.  But the officials said the agency hasn’t begun an in-depth review of the material and the company will have to wait its turn.

Boston Scientific’s filings are “in the queue, and we’re going to take it when it comes up,” said Gladys Rodriguez, an enforcement director at the FDA’s Center for Devices and Radiological Health who is involved in the review.  “At this point, we’re not expediting.”  The FDA has 30 days to do a review, Ms. Rodriguez said.

Translation from bureaucrat lingo: “We can’t be bothered.”  I mean, c’mon, it’s not like its their lives or money on the line.