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Millions dead from the initial impact, millions more will die in the months and years to come. This is the scene from ground zero of a nuclear attack. Our future can hold this and much more. What once seemed like something imperceivable has inevitably beco

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

me a very plausible scenario. Something, as simple as a private jet chartered from Canada into Montana (which goes unchecked) can transport a nuclear device into this country. Let’s take an even less sophisticated method of smuggling it in: someone driving

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

Examples of combination products may in

a car across the US/Mexico border plows through the checkpoints and steps on the gas, all the way to San Diego, barely a half hour away he drives into downtown and detonates the bomb. He might even do this as he is being chased. California is well known for

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

its car chases, so the police might even back off. These are some of the biggest threats we face in our country, and undoubtedly, there are many more.

There is one simple step we can take if not to stop but to at least minimize the threats to our American

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

way of life. By putting troops on the border we will effectively plug the porous borders we have to our north and south. Having personal experience in the military, I could tell you first hand that our primary task was to protect the perimeter from enemy pe

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

Combination pro

etration. Take this concept and apply it towards our borders, and it should provide the same level of security as it does in our military bases around the world.

The protection of our borders not only guards our citizenry, but also hinders illegal immigrat

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

ion and drug smuggling into this country. When you consider that we currently have anywhere from 8 to 13 million illegal aliens in this country draining billions of dollars from taxpayers by way of jobs, health care, and many other social services, that hav

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

and will continue to take its toll on local economies. A recent study conducted by the Center for Immigration Studies (CIS) says that illegal immigrants enter this country at a rate of 1,918 per day. Of these, consider that if only a tenth of these people

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

are criminals, then that is reason enough to put troops on our borders.

Securing our borders with troops, though, a simple solution to a complicated problem can however raise some concern in the minds of many people. Many, especially on the left are fearfu

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

that we will become a police state. One or two instances of excessive force are used as examples to convey their message, such as, when a Marine training along side the border patrol shot dead an illegal alien attempting to cross the border. Another argume

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

t made against this is that we will offend and possibly isolate our neighbors. Others maintain that we have to be sensitive to the needs of illegal immigrants, even the former Director of Homeland Security, Tom Ridge is quoted as saying that “we have cultur

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

Following aspects would a

al and historical” reasons for not putting troops on our borders.

Many times we need a significant life event to change our train of thought or consider other options on different issues. Placing troops on our borders is something the American people overw

dd to the challenges in developing combination products:

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

elmingly support as indicated by a recent poll: The poll of 1,015 likely voters by Zogby Int’l found that 68 percent of respondents believe the government should deploy troops on the borders to curb illegal immigration. Fifty-eight percent agreed that the U

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

.S. should admit fewer immigrants each year. The problem with this is not support for it, but rather another sticky political correctness ordeal.

Furthermore, on the legal side of things, there really isn’t much on the books stopping us from putting troops

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

on the border. The 1878 Posse Comitatus Act, which restricts the federal role of troops reads like this: “Whoever, except in cases and under circumstances expressly authorized by the Constitution or Act of Congress, willfully uses any part of the Army or th

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

Air Force as a posse comitatus or otherwise to execute the laws shall be fined under this title or imprisoned not more than two years, or both.” This law is basically principle oriented and not very legally binding because it has been weakened by amendment

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

Professional from academic institutions, pharmaceutical industries, health care indust

s authorizing limited use of troops on our borders.

Placing troops on our borders will not only serve to protect us but also to send a clear message to foreign nationals and enemies that we our willing to protect ourselves from them. This is an issue that

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

as only recently gotten more attention due to the September 11th attacks, but that many have had on their minds for a long time. Action is needed now on this issue, next time might just be too late. September 11th made us realize just how vulnerable we are.

.

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

Just as we are righteously pursuing terrorist around the globe, we ought not forget the first line of defense starts at home.

Works Cited

Kenne, Lara. “Tancredo, Congressional Immigration Reform Caucus Call on

President to Place Troops on U.S. Border”

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

Companies that provide selfless information through particip

8 June 2002. House.gov.

“Pandering to Mexico, Ridge won’t militarize border.” 1 March 2002. Newsmax.com

Wires.

“US borders still open nuclear smuggling.” 31 October 2002. Newsmax.com Wires.

“Using troops as cops.” 11 November 2002. Free-market.net

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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