Main Subject - Business

Breaking news may feature the Enron debacle, WorldCom activities, or accounting problems but we live our everyday business life making ethical choices that affect our employment and businesses. Consider the ethical choices

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

made in these situations:

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

Examples of combination products may in

r for his own personal benefit.

-An independent consultant who was hired to sell a particular firm’s services and products used that firm’s database of customers and prospects to sell his own speaking services.

-

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

n employee took a new job with a prospect’s firm and continued on working both jobs until the first employer found out and fired her.

-A business person volunteered to perform specific services for a nonprofit organiz

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

tion and failed to perform those services, did not make other arrangements to perform the services, or even acknowledge that the commitment had been made.

-An employee used hours of regular, paid, in-office time to re

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

Combination pro

earch how to start her own new business.

While these are not on the newsworthy scale of an Enron, they are on a scale that affected each business involved, some even resulting in disastrous outcomes.

We all try to l

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

earn from our own mistakes and from those of others as well. We now employ lawyers to write, review and potentially defend every business agreement. We are ready to go to court if need be. The distressing fact is all of th

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

t preparation and cost still will not stop someone from behaving unethically. And unethical behavior may indeed still be legal behavior.

What is so difficult about applying the concept of right and wrong to everyday busin

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

ss decisions? I would venture a guess that, sociopathic behavior aside, the vast majority of business people know when they are about to do something that is ethically questionable. Most will have a debate in their own min

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

s about should I or shouldn’t I. What is your instant response when you get change for a $20 when you know you gave the clerk a $10? The answer to that internal debate is what determines our ethical behavior.

While we can

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

point fingers at corporations, lawmakers and politicians, we have a personal responsibility to contribute to the ethical fabric in our everyday life. So how can we support each other is those debates? What can we do to hel

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

Following aspects would a

p each other arrive at an ethical decision and behave in an ethical manner?

I challenge every ethical business person to step up and make your voice heard when you witness unethical behavior. You not only have the right,

dd to the challenges in developing combination products:

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

ou have the responsibility to do so.

I challenge every business organization, every chamber of commerce, every professional association, every Rotary, Lions and other Club, to participate in a meaningful way in actively r

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

building business ethics. Not just in your mission statement, but in your day-to-day member services and even through your own leadership.

There are many ways to start right now to begin rebuilding a strong culture of bus

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

ness ethics. Use your ubiquitous brown bag lunch sessions to address the everyday dilemmas of business ethics. Select a speaker for your next luncheon who can address the process of making ethical decisions. Have round tab

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

e discussions about solving ethical problems. Schedule an ethics workshop at your next leadership retreat.

And on a personal level, participate in those meetings, sessions and roundtables. You can also mentor other busine

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

Professional from academic institutions, pharmaceutical industries, health care indust

ss owners, business people, employees and students in the practical applications of day-to-day business ethics. We need you to let your colleagues know that you find it unacceptable to behave in an unethical manner. Make i

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

plain and simple. Be clear with your peers that they can expect you to be ethical in your actions and that you welcome communication if they ever think you are behaving otherwise.

Let’s apply the 80-20 rule. If 80% of bu

.

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

iness people are operating in an outwardly supportive, ethical environment, don’t you think it will affect the 20% who are going through that internal ethical debate? We can affect this ethical morass we find ourselves in.

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

Companies that provide selfless information through particip

Let’s stop blaming the rest of the world, take a look in the mirror and make some changes.

* From the 1976 film “Network” written by Paddy Chayefsky. The line was delivered by Peter Finch who played anchorman Howard Beale

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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Have you ever considered why lawyers have the biggest advertisements in the Yellow Pages? Well perhaps you should think on which advertisements do the best in the Yellow Pages and why. If you are an established business you do not need to advertise in the Yellow Pages because you have plenty of referrals from satisfied customers.

With the growing number of free job sites on the Internet, plenty of opportunities appear to be available to the qualified candidate. Essential to clinching that dream job is the way an applicant’s resume is put together. Using free resume-building websites and examining free online job descriptions will help hone resume-writing skills.

Your organization is in a dire emergency. What do you do? The big guy just tapped you to turn it around. Read on and you'll know the first thing to do to make a powerful impact right now!

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