Friday, May 16, 2008

Irressistable to post: Hollywood Meets Riegel, Drugmakers and FDA: uninformed and uncompensated lab rats

[Click on Post Title for Link to External Article]

I don't care what you think of me, I don't know who Dennis Quaid is. But, I like his Hollywood style. Though brazen and "filmy", I completely agree. There is a problem with pre-emption. The FDA becomes judge and jury. In any democratic legal system that is a debacle.

We all know the effects of that. One has to only look at how the USPTO "regulates" or until recently tried to "regulate" itself and all of its customers, leaving a very bad taste in the mouths of several lifescience companies.

However, some of them are now trying to hide behind an anologous federal agency pre-emption situation.

Why wouldn't pre-emption benefit all of the industry? Very simple. Let's say your competitor is really selling a terrible product. And, unlike the present times when the FDA is displaying unparalleled levels of leadership, if said leadership were to degrade in quality at a future point in time!, neither you nor said company's unhappy customers have a reprieve.

All that needs to happen is, the FDA can take a look at boiling hearts and squeaking hips and say, "Bah, that was expected. It was not the manufacturer's fault. That is our decision. Of course, the investigation is closed and we won't tell you what happened". While this disastrous drooping of levels in the FDA is next to impossible, this is not just an unhappy customer's headache.

On the other end of the stick, is a problem where this happy state of squeaky hips, burned catheters and other quirks pile up for a while and then an appalled Congress picks up from there and over-regulates the industry. Getting a 510 (k) approval is tough enough, who wants new headaches?

Doubt it will happen? Tell that to the folks trying to end Sarbanes-Oxley.

From these two perspectives it becomes very important that Riegel should not have gone down the way it did. And it did. So now we are in trouble!

It is binding on any society that expects quality in service to create and maintain a system of checks and balances. Otherwise trust, efficiency, creativity and all other elegances will disappear into nothingness...

In face of this, it is important that Congress listen AND understand AND exercise an appropriate system of checks and balances.

Lets see if we succeed or wait till other Hollywood, YouTube, FaceBook and "Can you act stupider and sillier than a 2nd grade child" stars also show up screaming at Capitol Hill....

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