Why Businessfolk Hate Bureaucrats
By Vladimir Posted in Policy — Comments (8) / Email this page » / Leave a comment »
Businesspeople hate bureaucrats. Bureaucrats seem to be on an unlimited and unflinching mission to constrain commerce. In his unceasing effort to extend the grasp of regulation, the bureaucrat is rarely constrained by common sense.
An example:
My 18 year old daughter has mild asthma. She uses an aerosol inhaler from time to time which makes her breathing easier.
A few days ago we received the following letter from Gateway Pharmaceuticals [emphasis added]:
The Food and Drug Administration has proposed to make Maxair Autohaler(pirbuterol acetate inhalation aerosol) unavailable after December 31, 2009 as part of an environmental initiative. ... Creating a new formulation ...will take several years beyond the government's arbitrary deadline of December 31, 2009.
This is not a health issue to my family. My daughter can use a competitive, ozone-friendly product if need be. But that's not the point.
Here you have a private enterprise, legally pursuing a presumably profitable line of business that provides some benefit to its customers.
The Maxair Autohaler has a capacity of 14 grams (0.5 fluid ounces). It delivers 0.2 milligrams of medicine per use. It uses a chloro-fluorocarbon (CFC), supposedly damaging to the ozone layer, as a propellant.
First of all, I thought the ozone-hole calamity that threatened to end life as we know it was solved.
Second, since when does the FDA regulate environmental emissions? Note that they do not allege any negative health consequences of inhaling this stuff. They approved the formulation long ago.
Third, aren't the volumes of CFC gases released (in the hundredths of a gram per use), um, inconsequential, to put it mildly?
Fourth, the FDA arbitrarily set a deadline which left the manufacturer no chance to develop and market a replacement, thanks to the FDA's glacial review process.
Welcome to the Alice-in-Wonderland world of the Federal bureaucracy.
[edited in the interest of gender neutrality! - V.]
Maxair Autohaler differs from all other rescue inhalers in two key ways:
1. It is the only breath-actuated rescue inhaler device. It delivers a soft puff of medicine when you inhale, eliminating the need to coordinate activating the inhaler while breathing in the medicine.
2. Maxair Autohaler is also the only rescue inhaler that contains pirbuterol - a different medicine than many other inhalers that contain albuterol.
No one medicine is right for everyone, and Maxair Autohaler may be an important option for patients who have tried to use albuterol inhalers and had negative reactions.
Many people have found that only Maxair Autohaler treats their asthma because of one or both of these key features. If Maxair Autohaler is removed from the market, many patients will be forced to move to another product with a different medicine, a different delivery device, and a different formulation.
It's such a fine line between stupid and clever. - David St. Hubbins
but I guess psuedo non-science comes before human health issues.
Hillary Care will consist of five different colors of asprin - at $5 per pill. I can hardly wait..
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"Enlightened statesmen will not always be at the helm." -- James Madison
I wish you'd edit out your digressions about CFCs and upper atmospheric Ozone. The Ozone-destroying chain reaction that CFCs cause in the Ozone layer is known, and not pseudoscience of any kind.
And while we did enact a global treaty to ban the use of CFCs, the damage done to the Ozone layer will take time to naturally reverse, as solar radition gradually turns more normal molecular Oxygen into Ozone.
Now it's reasonable to argue that the amounts released by these inhalers are small enough that we can bend more, but you undermine your argument by overreaching.
Tell all the people suffering from the much higher rate of life-threatening skin cancers in Australia that the hole is a so-called calamity.
The fact that the tiny amount of CFC in an inhaler results in the banning of the medicine/delivery system. Focus on industrial and commercial CFC applications. I'm seeing how many cases I can procure before the ban takes effect. My son's doctor is helping us (She also thinks this is an absurd ruling).
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"Enlightened statesmen will not always be at the helm." -- James Madison
The ozone hole is not the issue. I think you're reading something into my diary that I did not say.
I know that I have read reports in the press over the last couple of years that suggest that the problem with the hole in the ozone is "solved" - I am neither an atmospheric scientist or an Australian epidemiologist, but it would appear that the concentration of the ozone-damaging chemicals in the upper atmosphere is declining. At any rate, global warming is getting all the attention nowadays.
As for "rant", my use of the word "supposedly" constitutes a "rant"?
I will stipulate that the hole in the ozone remains a problem. My point remains: attacking the problem 0.5 fl oz at a time is purely symbolic and merely a flexing of bureaucratic muscle, from an organization that shouldn't even be in that business to begin with.
It's such a fine line between stupid and clever. - David St. Hubbins
You will be pining for the good ol' days when the FDA told you what you couldn't have, rather than what you must.
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Gone 2500 years, still not PC.