Main Subject - Business

How would you describe the state of ethics in business today? Wonderful? Rock solid? No, I think most people are disgusted with it. They are sick of dishonesty and unethical dealings.

Of course the ethi

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

cal problems we're seeing aren't limited to just the business world. The public was horrified by the recently revealed abuses that occurred in the Catholic Church and how the incidents were covered up. M

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

Examples of combination products may in

ny were surprised by reports that Pulitzer prize-winning history professor Stephen Ambrose had plagiarized passages from historian Thomas Childers for his book The Wild Blue.

The Ethical Dilemma

Our di

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

sgust is now turning to discussion. People want to know: Why is ethics in such a terrible state? Although there are many possible responses to that question, it has been suggested that when people make u

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

ethical choices, they do so for one of three reasons:

1. We do what's most convenient.

An ethical dilemma can be defined as an undesirable or unpleasant choice relating to a moral principle or practice

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

Combination pro

.

2. We do what we must to win.

Many people believe that embracing ethics would limit their options, their opportunities, their very ability to succeed in business.

3. We rationalize our choices with

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

elativism.

Many people choose to deal with such no-win situations by deciding what's right in the moment, according to their circumstances. This is an idea that gained legitimacy in the early 1960's fol

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

lowing the publishing of a book called Situation Ethics, by Dr. Jospeh Flectcher.

The result is ethical chaos. Everyone has his own standards, which change from situation to situation. And that stance i

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

encouraged. A course entitled "The Ethics of Corporate Management," offered at the University of Michigan, says in its description, "This course is not concerned with the personal moral issues of honest

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 and truthfulness. It assumed that the students at this university have already formed their own standards on these issues."

So whatever anyone wants to use as the standard is okay. Making matters wors

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

is people's natural inclination to be easy on themselves, judging themselves according to their good intentions - while holding others to a higher standard and judging them by their worst actions. Where

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

Following aspects would a

once our decisions were based on ethics, now ethics are based on our decisions.

It's good to know that there is a desire for change regarding ethics in our culture. The bad news is that most people don

dd to the challenges in developing combination products:

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

t know how to make that transition.

Some Current MarketPlace Solutions

If you look at what's happening in the marketplace, you'll see that even though we desire honesty and plain dealing, we're still n

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

ot winning the battle of ethics. Take a look at how people in our culture are currently trying to address the problem. They ...

1. Outsource Ethics Instruction 2. Perform an Ethical Flea Dip (Think of

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

ashing a dog!) 3. Rely on the Law.

One of problems is that ethics is never a business issue or a social issue or a political issue. It is always a personal issue. People say they want integrity. But at

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

the same time, ironically, studies indicate that the majority of people don't always act with the kind of integrity they request from others.

The same person who cheats on his taxes or steals office su

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

Professional from academic institutions, pharmaceutical industries, health care indust

plies wants honesty and integrity from the corporation whose stock he buys, the politicians he votes for, and the client he deals with in his own business.

Companies that are dedicated to doing the righ

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

t thing, have a written commitment to social responsibility, and act on it consistently are more profitable than those who don't.

Let's go back to basics. How do you know what's right? How do you naviga

.

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 even the most difficult of pressure-filled situations? Where can you find a standard that will work in every situation - a guide that will help you to sleep well at night, prosper in business, improve

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

Companies that provide selfless information through particip

your marriage, and have confidence that you're doing all you can every time? My next article I believe will be the best answer to those questions.

Kevin McNabb Chairman www.global-online-networking.co

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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