Main Subject - Business

Ethics in business has become big news over the past several years. We read ab

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

out the escapades of the executives at Enron, WorldCom and other major companie

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

Examples of combination products may in

s and shake our heads in astonishment thinking, "How could that happen."We marv

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

l at the unethical behavior of these leaders while at the same time never consi

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

dering our own behavior.

The truth is that business leaders, regardless of the

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

Combination pro

size of the company, are faced with ethical pressures everyday. The scale or i

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

mpact of the ethical decision may not measure up to the likes of an Enron, but

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

nevertheless, they do exist. How a business leader handles minor ethical issue

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

is a precursor to how larger decision will be made as the business grows.

Man

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

y of the ethical issues we may face are not clearly black or white. In fact, t

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

o people faced with the same issue could quite possible make contrary decisions

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

Following aspects would a

, while believing they each have made the best ethical decision. Why? Because

dd to the challenges in developing combination products:

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

ethical decisions are based upon one's moral character. When it comes to mora

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

behavior, we each march to the sound of different drummers and as such will ma

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

ke different decisions on similar issues.

As a business owner you must set the

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

bar on ethical behavior. Make integrity a core value, be honest with your cust

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

Professional from academic institutions, pharmaceutical industries, health care indust

omers and employees, always follow the rules, never compromise your principles,

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

and remember that the right thing is not always the opposite of the wrong thin

.

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

. Do these things and your customers will respect you and your employees will

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

Companies that provide selfless information through particip

remain loyal, essential ingredients to a successful business.

To Your Success

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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