Tuesday, April 17, 2007

Governmental Efficiency

Amazing that the FDA will soon charge medical device companies 65% more for their device reviews, yet promise only a 9% reduction in their device review time:
(Wall Street Journal) The agency said Monday it will ask the industry for a 31% increase in fees in 2008 compared to fiscal 2007, with an additional 8.5% raise in each of the four subsequent years. Fees are charged for a variety of things including a fee for companies that file for premarket approval applications for medical devices.


In exchange for the additional fees that would be charged to companies, the agency has slightly accelerated its timetables for completing application reviews. For example, the agency has set a goal of reviewing 90% of applications for new medical devices within 295 days rather then a current goal of 320 days.
But AvaMed, a conglomerate "trade group" (a.k.a., lobby) of Big Business interests is behind the move, it seems.

I wonder why? Is it really on the basis of improving safety for the patients they serve?

Or might this be an alternate means to cooerce the judges while providing funds to other elected officials?
“We look forward to working with policy makers to move this important agreement through the Congress,” said (Stephen J.) Ubl.
Once enacted, it'll be hard for Congress to ask device companies to lower prices, won't it?


Mr. Stephen J. Ubl is president and CEO of AvaMed.

Reference: The FDA Announcement

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