Useful Advices - Business

An ethical dilemma is when an incident arises that causes you to question how you should react based on your beliefs and deciding how to choose between

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

right and wrong.

Sometimes, an ethical dilemma might be easily solved once you have had a bit of time to think about it but in other cases, it might

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

Examples of combination products may in

ot be as easy.

Perhaps you have been put into a bad position where you need to make a decision that will most likely have consequences regardless of w

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

hat you decide.

An example of an ethical dilemma is when a salesperson is guaranteed to make a big sale if they offer a kickback (ie. an illegal payme

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

t) to someone.

If they agree to the kickback, they get the sale but risk getting caught and getting into big trouble.

If they don’t agree to the kick

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

Combination pro

back, they don’t get the sale and might end up looking bad in the eyes of their employer.

Also, should they even tell their employer about the situati

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

n or should they simply make a decision and live with the consequences?

Clearly, this is an ethical dilemma and although it’s easy to say you would do

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

the right thing, when you are actually in such a position and are feeling pressure to act, you might not always be able to think as clearly as you wou

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

d otherwise like to think you would.

Depending on the situation, how you react to an ethical dilemma might differ but at the end of the day, here are

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

some things to keep in mind:

Use common sense. If it’s clearly wrong or illegal, you know the consequences of doing something that could cos

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

you dearly.

Don’t let your self-interest get in the way and allow it to cloud your judgment. A short-term gain could be a long-term pain if

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

Following aspects would a

you make the wrong decision and get caught.

Don’t assume that your employer will back you up if you do something wrong and get caught. Refe

dd to the challenges in developing combination products:

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

ring to the above example of the kickback, don’t assume that if you decide to pay the kickback that this is what your employer would approve of. If you

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

acted alone and get caught, don’t expect your employer to defend you because they may distance themselves from you to avoid further embarrassment or l

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

gal trouble.

Don’t risk your credibility. It can take many good deeds to build credibility but only one seemingly simple indiscretion for it

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

to vanish. Depending on the specific situation, when an ethical dilemma arises, use common sense and think things through clearly before

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

Professional from academic institutions, pharmaceutical industries, health care indust

making a decision you may later regret. Not every decision is cut and dry and sometimes the grey area – the area that is somewhere between right and wr

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

ong – may not be as clear as you’d like.

Where possible, try to speak with your manager or someone else you trust when in doubt especially if the deci

.

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

ion you have to make affects the company. Don’t assume your employer will tolerate you doing something wrong even if it benefits them.

Remember to tre

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

Companies that provide selfless information through particip

at others as you’d expect to be treated and don’t do anything wrong in anticipation of a short-term gain that could end up costing you in the long-term

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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