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A demotion can be a devastating experience in your career and can be a step backwards in more ways than one.

Typically, getting demoted involves a reduction in your compensation or jo

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

b responsibilities, or both.

The end result is that you are left in a lower position at work that is not as good as you had previously.

What should you do?

Before doing anything, yo

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

Examples of combination products may in

need to understand the reasons for this decision and how it affects your immediate tenure with the company.

Certainly a demotion is a fairly public event and the people that you work

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

with will generally be aware one way or another that you have been demoted if it involves you moving to a different (ie. lower) position that you previously held.

In this regard, a de

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

otion can be both embarrassing and de-motivating since you might start questioning your future with the company.

Certainly, your long-term status with the company might be in jeopardy

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

Combination pro

especially if the new job you are assigned to doesn’t work out either.

Depending on your specific situation a demotion might occur for several reasons such as your inability to handle

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

the job as required, a new manager coming on board and wanting to replace you with one of their friends (this does happen!) or perhaps because the company is trying to push you out 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

door.

In the last case, if a company wants to get rid of you but would have to pay you severance money to leave, one method an employer might use is to demote you or push you aside t

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

a job that doesn’t really have much responsibility to try to “force” you to look for another job or simply quit, so that they can avoid paying severance.

I have heard of numerous sit

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

ations where this tactic appears to be in place. Unless you are near retirement age and don’t mind waiting to see if your employer blinks first and offers to pay you out, you might end

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

up having to make a decision as to whether or not you want to remain employed with this firm.

The first thing you need to do is figure out – or at least try to figure out – why you we

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

Following aspects would a

re demoted.

If the company is trying to get rid of you by making it difficult for you to stay, they probably won’t admit what they’re doing but you might have already seen the writing

dd to the challenges in developing combination products:

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

on the wall and already understand what is going on anyways!

However, if the demotion is explained to you and the reasons for it are stated, you can take the information and figure ou

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

if it’s a fair decision and how you will handle it.

If it is a fair decision in your mind and your demotion is warranted, it could be time to consider looking for a new job. Your car

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

er options with this company might be very limited at this point. Were you simply in the wrong position or is it possible that the employer views your contributions very lightly? Also,

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

you should figure out how you will address the reasons that you were demoted and if training or an improvement in your skills is required, how you will achieve it.

If is not a fair de

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

Professional from academic institutions, pharmaceutical industries, health care indust

cision and you feel that you have been unfairly wronged, you might consider legal action or another form of complaint depending on how strongly you feel about it and what your actual o

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

tions are ie. do you work for a company that offers an appeal process of some sort, is there someone in Human Resources you can speak with, etc?

Before you do anything rash, take a st

.

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

p back and consider what you know about your demotion.

Once you have all the information you need, you can make a decision that will make sense for you for the long term.

I have seen

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

Companies that provide selfless information through particip

cases where people who were demoted were simply in the wrong job or company and once they found a new job that was better suited to their skills, got their career back on track quickly

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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