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The United States and other first world nations have been asked to forgive debts of foreign third world nations. We have obliged in doing so. This is a tremendous gift to the world, yet there are a

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

few problems with this. Number one; that money, we as a nation are paying interest on the debt. It adds to our national debt. Another issue is that when you give away money you make others weak; “

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

Examples of combination products may in

ive a man a fish” theory. Often when we give other nations monies we do so for a specific ear marked use.

Often what we find is that the nation’s leadership lacks the integrity to use all the moni

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

s for the appropriate endeavor. In Nigeria the leadership absconded with money, which was ear marked for the impoverished and for medical needs. Yet the leadership bought a band new Gulfstream Jet

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

ircraft. Of about 45 million given in this one instance, 30 million was spent on hangar upgrades, pilot’s salaries, security and the aircraft itself. Only 15 million is “Said” to have gone for its

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

Combination pro

ntended purpose. This minor example is irrelevant in the over all scheme of things, as this goes on worldwide.

As we end up forgiving the debts of nations in the third world, we must realize that

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

here are significant issues. We keep pointing to the poor and impoverished and how it is not fair. Indeed, everyone agrees that is a travesty, as water supplies, raw sewage, diseases, power, commun

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

cation and education all need funds to get going and a nation in debt behind the eight ball can never get out of dodge. Similarly those who work at low wages in the United States often find the cos

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

s of living in excess of the salary they take in causing issues with insurance, driver’s licenses, apartment rental, health care, proper food nutrients and then credit card debt and poor credit rat

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

ngs. This makes it impossible for them to get out of debt. So the issue is fundamental and indeed quite simple to understand.

It is hard for some to wish to forgive the debts of such nations, beca

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

se the money was not well spent or stolen. It seems if we are to forgive such large debts to foreign nations we need to rethink our future strategy at the World Bank. Here is a thought. If a countr

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

Following aspects would a

y “wants” funding then we ought to see what it is for. Then hire US or First World Nation Contractors to build whatever it is they need in those third world countries ‘wanting’ money. I propose tha

dd to the challenges in developing combination products:

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

we have first world nations under contract and fair transparency of accounting go in and build those things, which are necessary for level playing fields and civilization. The Flows of civilizatio

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

are in fact necessary to allow for the forward progression of a culture or human based society. When I say “flows of civilization” I refer to those things that first world nations have secured tha

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

have allowed them to remain solid foundations and civilizations; The flow of water, energy, transportation, communication, distribution, education, common currency, common language, trade, etc. ar

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

keys to any ongoing civilization. If you invest in those things you will find a greater chance for success on collecting on the loans and even if you have to forgive some in the future, you will s

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill have made out ahead of the game for the people living in such regions.

I propose that sewer treatment plants, water filtration, wells and desalination plants be first on the list and build stu

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

dy enough that even direct hit from a 500 Lb. Bomb will not hurt them. Many third world nations are still at war, but the infrastructure must remain in tact. If you do not have clean water everythi

.

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

g else is for not because people will be dying and the child mortality rate will remain 5:1. It is possible to do this and needs to be done this way. Also those companies under contract to build hi

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

Companies that provide selfless information through particip

hways, communication systems, schools, agricultural infrastructures and water facilities should be required to hire local labor and train them too, whenever feasible. Think on these thoughts please

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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