Apr 13, 2014

FDA Dysfunction

Marginal Revolution has a post on the FDA and sunscreen:
Excellent piece in the Washington Post on the FDA and sunscreen: 
…American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade.  That’s because applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers.
…The agency has not expanded its list of approved sunscreen ingredients since 1999. Eight ingredient applications are pending, some dating to 2003. Many of the ingredients are designed to provide broader protection from certain types of UV rays and were approved years ago in Europe, Asia, South America and elsewhere.
If you want to understand how dysfunctional regulation has become ponder this sentence:
“This is a very intractable problem. I think, if possible, we are more frustrated than the manufacturers and you all are about this situation,”
Who said it? Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research! Or how about this:
Eleven months ago, in a hearing on Capitol Hill, FDA Commissioner Margaret A. Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.”
If this is high priority what happens to all the “low priority” drugs and medical devices?
The comments bring up the fact that the EU and how it is generally five years ahead of the FDA in approvals for some devices.  Transcatheter Aortic-Valve Implantation (TAVI) is a good example, where the EU has second and third generations of devices from a wide range of companies available.  The US has two first generation devices approved.  This is a good situation for the original approval to be sure, as they profit from their willingness to spend enough to perform a large clinical trial and get US approval.    However, I'm not so sure it is so good for the US consumer, even if the improvements of some of these products may be minimal or equivalent to the first device approved, it at least introduces competition and lowers the price. OTOH you could argue that it may not be so good for the EU consumer as they may have some ineffective devices on the market that people are buying.  Both systems require companies to demonstrate safety, I am assuming they both do so effectively.

11 comments:

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