On Scott Brown's unfactual rant...

It is like a scene from a bad cowboy movie. Or, a Chuck Norris episode, with GMC trucks and everything. Scott Brown was probably "coached" by his friends at some of the Biotech companies which have impressed on how they have to "train" FDA officials who are regulating them.

Equipped with this, he went and stood in front of a whole bunch of his Biotech friends in some dog and pony show in Massachusetts in his probably inimitable style, that gives no credence to facts or reality.

Here is a dose of what he is purported to have set. "Whether it’s the FDA, EPA or the “ABCDEFG, you name it — there’s so much overregulation right now,” he said. “When you go overseas, the processes are down, they’re set.”".

Too bad, entry into the U.S. Senate is not even under-regulated you say?

Well, according to Scott Brown's constituents, you have to drive certain vehicles, and take money from donors and recite what they ask you to say. See, the process are down, they're set!

Fighting with facts!

You may not like how the FDA regulates things. And if you choose to do so, you can fight in a way that doesn't make you look like a special-plastic smelling aficionado! Just don't do what Scotty here has done - ranting so poorly that one of the FDA spokespeople who he might deem "lacking in mental capability" was able to come out and say that Scott Brown is mostly, if not completely wrong - without having to try hard! As to mental capabilities, what do they say about it taking one to knowing...

Given that more devices and drugs have been approved over the past decade than ever before, and given that the US is still one of the safest bets as far as medical standards go, Scott Brown's statements make him look very eligible to hire himself out to children's parties for some quality entertainment, which some cynical people might deem all politicians to be eligible for...

Cacophony

Armed with the unfortunate ability that renders any ill-minded person to register "non-profits" in the US, a couple of them have engaged in all kinds of cacophony about "over regulation", "loss of competitiveness" and other terms that they can express without developing even a superfluous understanding for.

While the people of a state should observe and regulate their regulatory agencies, it has to be done without rants and forged reports. Bring up the facts, and urge patient-oriented action, not profit or donor oriented action.

Consulting "Experts" - the wrong way

On the other hand, Senator Franken got too excited and has asked the FDA to consult "experts" in the device industry before making changes to device approval processes. Er., should the cop stop you on the freeway and consult you on whether you were speeding or how much the ticket should cost you?

The right way

Health advocacy agencies that don't take money from biotech and device firms; consumer non-profits and other members of the public who have an understanding that goes beyond the sound-bites handed to US senators should be the ones most actively engaged in discussing any industry's state of regulations.

Senators, biotech companies and others have a right to fight regulations too, if they plan to do it with facts, sanity and coherence. That day, pigs plan to fly...

References:

1. http://www.bostonherald.com/business/technology/general/view/2011_0622fda_fends_off_browns_attacks/srvc=home&position=also

2. http://www.fiercebiotech.com/story/sen-brown-accuses-arbitrary-fda-crushing-biotechs/2011-06-22?utm_medium=nl&utm_source=internal

3. http://www.medcitynews.com/2011/06/sen-franken-to-shuren-get-industry-input-before-changing-510k-system/

Commonsense and/or a fear of dead patients prevails in China..

[Click on Post Title for Link to External Article]

I don't know what ticked off the Chinese initially - that they required a "near 100% inspection of ALL imported medical devices". Maybe it was the fact that they were packing toys with lead...yes it did happen, but enough with it already....

Maybe it was global ex gratias such as Lou Dobbs who have the genius of converting minor issues into apparent major disasters.

Maybe it was the fact that the US and folks around the world in general over-reacted to production quality of Chinese goods.

Well whatever it is, both parties are guilty. If production coming out of China was truly off quality, it was not just the factories that needed to share the blame - atleast not always. Many US and other international organizations have subsidiaries in China. Wouldn't it be a shared responsibility then, to reassure everyone of product quality?

Would it hurt Walmart and other toy stores if they checked products for lead or other mishaps before loading them on stores? Apparently, it would! They are unwilling to play their part - then their yellow smiley cannot keep smiling as the prices would go up. So they blame it on China...and a guy hangs himself...truly nasty!

And, recently China seized toys and products coming into their country from elsewhere that had product defects....it only proves one thing. Many of these companies and countries share a common attitude when dealing with China, "Do as I say and not as I do...."

Would it really work?

No!

Why?

Simple: China is an emerging superpower. Keep ticking them off and lose any percentage of 1.3 billion (and counting) customers. Same would go for China.

The equations and dynamics are changing. The difference between the "old" world and the "new" world is shrinking..helped by a dollar that is on a downward sliding scale. Even when the dollar picks up, if it does, as predicted in 2009, the world would have changed by then....

Companies and countries should realize this, and learn to present a picture of equanimity and commonsense when criticizing...and of course make sure they don't have glass doors before they throw stones at anyone else! So can someone shut up Lou Dobbs already?

But China, how naughty of you?! Did you really think you could do a 100% incoming inspection....And Thank God for the patients who really need those medical devices!


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