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It is certainly no wonder that there is sharp division and controversy in this Country on the subject of immigration. After all, the American attitude on the subject is conducive to mixed emotions which, in this writer’s opinion, rise to the level of schizophrenia. This

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

phenomenon is hardly new, although a superficial survey of current punditry would have us believe that this whole subject has risen to public consciousness only in the past few months.

In the middle of the 19th Century, a huge wave of Irish immigration, fleeing the potato

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

Examples of combination products may in

famine, arrived at our shores. Americans of Anglo-Saxon origins were very resentful, and frightened about the prospect of lost jobs. Sound familiar? Those of Anglo-Saxon origin had, of course, themselves been immigrants not so very long before. The Irish immigrants, qu

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

ckly found a niche for themselves, and acquired political clout. So when Eastern European Jews, Italians and Slavs arrived in the late 19th and Early 20th Centuries, the Irish were in a position to resent those new arrivals, and did so quite vociferously.

“Give us your 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

red, your poor…?” Nice words, to be sure, but rarely meant by the entrenched American populace.

Then, as now, it was the immigration of people seeking opportunity which, in large measure, gave our country the energy and vibrancy which built it into a mammoth industrial a

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

Combination pro

nd economic machine. Now, we are hotly debating the issue of immigration once again, with both sides of the question asserting valid points in support of their respective positions. I would argue that, at the end of the day, a compromise somewhat in the nature of that pr

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

posed by the President is inevitable, but hardly sufficient to address the real and much more fundamental problem that we face. It is, rather, roughly analogous to “shifting the deck chairs on the Titanic."

It is certainly true, as argued by the “seal the borders” consti

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

uency, that, while we want to encourage immigration, it should be legal immigration. People have been following the rules, and waiting their turn, pursuing the right to enter into and work in this Country and to become citizens, according to the laws enacted for that purp

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

se. Why, the argument goes, should people who snuck over the border and who have not been paying taxes, and have been receiving public benefits, schooling, etc., be permitted to “jump the line.”? A very valid point, to be sure. This Country has a strong interest in enfo

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

rcement of its laws and, equally importantly, an interest in being seen to enforce its laws.

It is also true, however, that as a result of the confluence of intermittent enforcement of immigration policy coupled with labor policy, our American Economy is now based on a sy

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

tem which not only tolerates, but requires illegal immigrants. We have a minimum wage system, a labor union structure and laws which, while certainly desirable in many respects to American Labor, has made us, in large measure, unable to compete in a global economy. Hence

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

Following aspects would a

the ever-increasing export of jobs overseas. This is why, when one calls Microsoft Tech Support, he or she is connected to someone in India. The cost of employment in the U.S. mandates, in practice, though technically contrary to law, that a cheap labor pool be availabl

dd to the challenges in developing combination products:

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

for low-end, unskilled work. Although it is often said that illegal immigrants are doing jobs that Americans won’t do, I do not really thing that that is necessarily true; rather, the cost of having American citizens do those jobs would drive up prices in certain areas,

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

such as manufactured goods and agricultural products, to a level which Americans would find intolerable.

Thus, even if it were practical to deport 11 million illegal immigrants, I believe that such a move would seriously threaten the viability of the real economy (i.e., t

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

e one we don’t admit to) of the United States. The proposed alternative is to find a way to bring these immigrants into the mainstream, and to give them, ultimately, the opportunity to become legal, taxpaying citizens. The flaw in this, of course, is obvious. Once these

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

illegal immigrants become legal, they will, among other things, have to be paid the minimum wage, and the entire benefit that we surreptitiously and hypocritically derive from our underground, illegal workforce will be lost to us.

Ultimately, therefore, the problem is not

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

Professional from academic institutions, pharmaceutical industries, health care indust

immigration. It is, regrettably, a much larger and more difficult one. How do we compete? We cannot produce goods as cheaply as India or China. We cannot impose punishing trade tariffs, because that just invites reciprocation, and black marketeering. America, I believ

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

e, is in serious danger of losing its preeminent position on the world’s economic stage. As it stands today, our only remaining and potent weapon is our seemingly insatiable consumer market. We need our economic gurus to figure out ways to leverage that into rewarding ou

.

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

friends and penalizing those who would bury us as an international economic power. There is no time to lose. And while sealing borders on the one hand, or creating the illusion of a country dedicated, on a renewed basis, to opportunity for the dispossessed may make us f

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

Companies that provide selfless information through particip

el good for awhile, neither of these paths will solve the real problem. We are victims of our own success and prosperity, and the rest of the world wants what we have. If we don’t protect it, it will surely be taken from us, and soon.

Warren R. Graham
Copyright 200

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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