Useful Advices - Business

Have you ever been at work and noticed something highly unethical happen. Did it bother you to the point you almost quit? Well did you know that 38% of all Americans have had the

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

same experience? A recent survey seems to indicate that we have an ethics problem in the United States and it is not just in Government or with cheating spouses. It is also preval

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

Examples of combination products may in

nt in the Work Place as well. But if you do quit your job, well who is going to pay the bills?

It is amazing how easy in life it is to become 'ethically unemployable', but integr

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

ity is something that is becoming more and more scarce in our world. But you know what can you expect from a bunch of humans. The interesting thing about ethics is that it is so p

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

rception based. The person at your work who caused this ethical event that you are now thinking about since I brought it up? I bet they had some justification didn’t they?

So hol

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

Combination pro

that thought for a moment and consider the issues of the "Ends and Means" debate. They say sometimes; “The Ends do not justify the means.” Indeed this is true, sometimes, but a p

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

ragmatist might say that sometimes the Ends are so great that the means are justified to win, complete the task or perhaps in a company make the deal? But still you shrug, why? We

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

l, because you are an ethical person and we are deeply troubled discussing this aren’t we? But we also realize that there are rare circumstances when as much as we do not wish to

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

dmit it, well the ends might possibly, justify the means

For instance, inadvertently hurting a few to help the whole. Now that stands against everything we stand for in the US, h

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

owever realize that it is unfortunately bathed in truth that sometimes you have too. I am sure you can consider examples of this and we are dealing with these issues now in some r

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

cent political events, which have been brought to light aren’t we? Or rather aren’t we always?

Now then is the “Ends do not justify the means” debate is an ethically troubling is

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

Following aspects would a

ue indeed. But what if we turn it around; what about the "Means do not justify the ends?" For instance what if you do the right thing, because it is the right thing to do, rather

dd to the challenges in developing combination products:

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

than focus on the ends (winning) and then your poor decisions fails to secure the necessary objectives and the whole of all involved are severely hurt because you did everything "

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

olitically correct" for instance but in doing so you built a really bad Dam? And the dam broke and everyone died. But you can save face because you did what was ethical in the pro

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

ess to build the dam without offending anything or anyone else?

So, often the ethical debate misses that flip side of the argument. The true answer in many cases is to do nothing

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

. Yet in doing nothing there is no progress, no progress means nothing gets done and stagnation occurs which is a travesty also. So, then in ethical debate this is to be considere

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

Professional from academic institutions, pharmaceutical industries, health care indust

, as well, we must consider the opposite in the “Ends do not justify the means.” A pragmatists can do this, politicians have to, otherwise they cannot survive? Is this best for t

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

e whole? Sometimes, because you have forward progression, other times it is not good for the whole, but serves the few. Yet sometimes what is good for the few is good for the many

.

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

(Ayn Rand type theory) so that also must be considered. So ethics is tough, but suffice it to say the best way to look at things is to encircle them from all perspectives and the

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

Companies that provide selfless information through particip

you get a better picture. Ask yourself is it fair for all concerned; yes or no? If not find a third way and think hard on better and more ethical decisions; Think on this in 2006

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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