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In response to Douglas Bower’s article; Logic Class 101 Applied to the Minuteman Project and on going topic of the BS at our borders, I wish to comment. First I agree with the Professor regarding the rhetoric and questionable comments from the Minute Men,

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

I agree with the problematic liability, I agree with our own national debate that few in our population see the issues on both sides. We have Bill O’Rielly and other commentators on one side and we have those who wish to make a better life supplying the la

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

bor we need on the other side. We have 5.2% unemployment and that number is so low we need labor to run our civilization pre-robotic era in our present period. Now then in his article:

http://ezinearticles.com/?id=48462

I submit points of debate and cont

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ntion. And other perhaps not even my own, but other sides to the issue. . .

Let's say we have open season on illegal border crossers. And a few people are shot and killed for trespassing and entering the country illegally. Then in fact fewer would want t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

o risk being shot and then would come in the correct way as per law. Additionally if illegal border crossers come over thru the hot 108-degree desert and end up dying at a rate of approx. 200-300 per year, then they would stop, having not wanted to be shot

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

and killed. Thus if your shot only a few the rest would stop. If they stopped less people would die. Correct. Also those entering the country on 1-3 day shopping passes could do so thru checkpoints like everyone else. Also realize that those with work pas

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

es can stay and work as they normally would.

I also see rhetoric on he side of government. The call the illegal aliens, illegal, yet refuse to enforce law. Then if they were not going to enforce it, make it legal and then no one would trespass to come ove

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

r here since they are allowed to drive across in buses? Additionally what about the drug trade and the armed military assistance in Mexico, corruption and former intelligence personal from Mexico assisting the drug smugglers? These are issues and reasons f

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

or border security are they not? Is the professor pro-illegal drug? If so is the professor, pro-crime? Is the professor pro-health care too? After all kids doing drugs ruin their bodies and have heart problems etc. by age 35, who is paying for that? We nee

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

to stop the drugs, enforce our laws or change them; we need to protect the American people and that is the most important and first job of our government. If our government fails to do so and citizens; "Citizens Border Patrol Militia" has a Constitutional

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

right to do so. If the government fails to protect the people, it foremost responsibility, then we has a problem with living a lie. If we cannot trust the government to enforce its laws or defend our safety are we not any better than the Romans causing th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

eir own collapse.

Phony Baloney aside Mr. Professor, I must ask you, what is the solution then. We have drugs coming over our borders, we have insurgents too, we have those with diseases which we have eradicated, we those who are criminals, MS-13 gangs. T

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

is cannot go on like this. Additionally there are of course the workers who are trying to make a better life and America does stand for helping such folks, we have not forgotten most all of us have come from somewhere else. But we came legally and we must

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

honor their hard work too and not throw our country over to an anything goes society. So then solution please? 50% of our population is very supportive of the Minutemen type groups. The other half finds them problematic. After all they are vigilantes in a

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

way as the president states.

MS-13 said that they in fact had declared war on the Minute Men? An organized gang known for killing folks and distributing drugs with an estimated 4000 plus members? Gee professor, whose team are you on? I agree that the blee

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ing heart liberals running this school see it differently and he brain washed masses attending college do leave with such a slant, but surely we should be protecting our borders? What is government for? If the government fails to protect us either way, we

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

take up arms now or we take up arms later? Huge military, budget, etc. and borders are leaking drugs and gangs, and maybe a few video taped staged masked pre-tenda insurgents too? Either way we need a better system, which promotes freedom, neighborly condu

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ct, trade and our human right to travel. So then how about a better check system and a little help from our Mexican partners. They are not taking us seriously. It is dangerous to pretend there is no problem here, we do have a problem and indeed we need act

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

on, whether it is a volunteer effort or if the government takes action and keeps its promise to protect us makes no difference. The problem is real and we need solutions. I applaud the minutemen's spirit to do something, but fear it maybe not quite the rig

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ht method and further fear what ever they do, do, well, it is being drowned in political correctness of the media and further fear that the government is not really wanting to protect us at all on our own borders. What about the Jordan Commission Professor

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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