Advice Pool - Reference and Education

It was not my fault.... or so they would have you think. I'm talking about people who have a real problem with accepting any responsibility for their own role in their own personal situations or actions.

How many times have you been

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

in a situation where you knew you were absolutely in the right? And despite even having solid proof to support your position, the emotional blamer refused to accept any responsibility for their role?

I feel as if it stems from childhood and these p

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

Examples of combination products may in

eople have been conditioned since that time to belive this behavior is acceptable. They think it's acceptable because it's partly all they know and it also has to do with the fact that they are in a comfort zone and no one has stepped up to challenge

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

them out of it.

By challenge them out of it, I mean just that. These people need someone to challenge them to get out of their comfort zone and to explore the true reality of responsible adult behavior.

This sounds easy enough but of course the nu

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

mber one obstacle you will encounter with emotional blamers is denial. When a person has any type of emotional issue, it always comes from an association of pain or trauma. The emotion is their escape. It's how they deal with it. For many, it's all t

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

Combination pro

hey know. And these people think their behavior is normal.

A child picks the behavior up from a parent. It's called modeling. They see mom and dad do it... so it must be acceptable and all right for them to do it as well.

An emotional blamer is alw

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

ays going to find some reason to push the blame on to the next guy and to come up with a reason or multiple reasons if they need to justify themselves.

But perhaps the saddest part of the emotional blamer behavior is that some actually know deep dow

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

n they are dead wrong. And yet they remain an emotional blamer anyway.

It's like they weigh the two behaviors in their mind and pick the least painful one and stick with it. Which in this case is actually the most painful to them in the long run.

A

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

n emotional blamer will encounter a life full of disappointments and continual frustrations. They will have a limited number of friends with one exception.

People who engage in this type of dysfunctional behavior always tend to seek out and befriend

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

others who are just like them to act as their support mechanism or enablers.

This of course is the worst thing that could happen since the emotional blamer does not have anyone in their life to challenge them out of the behavior and to grow as a pe

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

rson.

I liken this to a person who keeps walking sideways across the road going from side to side instead of walking forward and actually making progress on their journey.

For the emotional blamer, they do not want to go forward. They fear the unkn

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

Following aspects would a

own and are more comfortable with people and surroundings they already know.

The question becomes how do emotional blamers ever get ahead in life and go on to become great creators of success? Sadly the answer is pretty obvious isn't it? They don't.

dd to the challenges in developing combination products:

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

They would rather remain in their comfort zone and in the world they created, even if it is not a world that includes rational behavior.

The next time you encounter an emotional blamer, ask them to allow you the benefit of asking them two simple qu

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

estions...

What Role Do You Have In The Problem?

Can You Define The Responsibility You Personally Have?

Emotional blamers will always quickly attempt to do one of two things. They will either dismiss your question

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

s as stupid questions because they know deep down to answer them truthfully would mean they must admit they do have responsibility. Or they will actually try to wear you down with lengthy explanations and logic that will only ever make sense to them.

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

Remember, the emotional blamer does not want to freely admit they are wrong or they bear any fault or responsibility for anything. Even if they know deep down they do. They associate a lot of pain and fear with doing it. However there is one thing

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

Professional from academic institutions, pharmaceutical industries, health care indust

you can try.

Most of the time emotional blamers have their guard way up. Their protective shields are always in place and trying to get through and get those shields to drop even just a little bit, can only be accomplished in one way. You have to tu

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

rn the tables on the emotional blamer and present your position such a way as to enable them to have an escape. You need to make them feel as if it is ok. They need to know their pride will still be intact afterwards and you will not laugh at them, o

.

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

r say anything to cause them emotional pain or discomfort.

Emotional blamers do not want anyone to make them feel as if they are not as intelligent. They see any blame or attempt to place blame or responsibility on their shoulders as you calling the

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

Companies that provide selfless information through particip

m dumb.

So always remember to watch how you present yourself and what you say to someone you suspect as being an emotional blamer. With a little practice you might even be able to help some folks out by challenging them out of this dead end behavior

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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