Main Subject - Business

We hear a lot about business ethics issues in the United States and yet our businessmen and women are some of the most ethical business pract

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

itioners anywhere in the world. The transparency, integrity and accountability in American business is not found anywhere else in the world.

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

Examples of combination products may in

With all the disclosure, over regulation, lawsuits and government forms it would be difficult to call any American businessperson unethical.

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

Yet, we find that the mass media hysteria, incited by folks who do not understand commerce has cheated the positive American opinion about b

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

siness ethics.

The truth of the matter is that ethics in business, the military, sports, government or even the nonprofit sector in the Unit

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

Combination pro

d States is a reflection of the overall ethics of the average human in our civilization. For someone to say that people are less ethical in

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

business than let's say it law-enforcement; this would be a failure to adequately observe the reality of the situation.

Many people believe

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

hat our court systems and lawyers are of the highest ethical standards, but it simply is not so. Even the fine folks in government who are r

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

gulating the business community have to draw from this same population base. This is why the ethics in Government are no better than those i

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

business; perhaps Government ethics are worse because there is less oversight. Is this good or bad? It is neither, it just is.

For us to

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

iscuss business ethics properly we must be honest with ourselves, we cannot simply label all business people as crooks, shysters or con men.

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

Following aspects would a

Unfortunately it seems that many people in our society are pointing fingers at the business community, when in actuality they should be look

dd to the challenges in developing combination products:

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

ng in their mirrors. In this book we will discuss and contemplate the reality of human psychology and ethics and look into the abuses of powe

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

in government, government regulators and how over regulation to prevent criminality in business is a self-fulfilling prophecy and how we are

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

making criminals out of hard-working men and women and our brightest entrepreneurs.

As a businessperson and a Franchisor, I have been critic

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

l of over regulation at every level; Associations, City, County, State, Federal and International and more often than not government agencies

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

Professional from academic institutions, pharmaceutical industries, health care indust

, Trade Organizations and Associations are used by companies to attack their competitors. In fact, that in itself is unethical and once again

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

proves that you cannot regulate morality and if you allow those who will point fingers to assist in the abusing of power you will undermine t

.

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

e inherent integrity of free-markets between buyers and sellers. I hope you will enjoy this discussion and the thoughts on business ethics a

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

Companies that provide selfless information through particip

d I thank you for reading this article, as it is one of my first on this subject. Perhaps this topic is of interest to propel thought in 2007

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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