Actual - Finance

Debt is one of those things that you never see coming. It is so innocent. So quite. Yet it

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

is deadly. It is addicting. It will control you before you even know what is going on.

It

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

Examples of combination products may in

sounds a little overdramatic. But it isn't. Debt is one of those things that flips on you.

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

You have it in control one day, the next, it has you. Many of us realize that it is getting

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

out of control, but we don't do anything about it. We ignore the warning signs. We continu

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

Combination pro

to contribute to its hold on us.

Credit cards are just the beginning. Before you know it,

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

you can justify anything. And it will eat your finances, your peace and even your relation

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

ships.

First, you must recognize that you are addicted. This is hard for many. We hate to

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

admit that we have messed up. I've been there. Hindsight is 20/20. But once you have beaten

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

it, you are wiser. You see things more clearly. You understand what you did to get there.

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

nd you see it in those around you.

Ask yourself:

Have you been requesting credit increase

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

Following aspects would a

s lately? Are you maxed out on your cards?

Do you have trouble paying your monthly bills d

dd to the challenges in developing combination products:

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

ue to lack of funds?

Are you using your credit to pay for groceries and other living expen

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

ses?

Do your credit card payments exceed 20% of your monthly income?

If you are answering

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

yes, then you are becoming a debt addict. If you whip out that card without even thinking,

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

just to be shocked when the bill comes, you are an addict.

What can you do? Start changing

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

Professional from academic institutions, pharmaceutical industries, health care indust

right this minute. Fix the problems right away. Take steps to identify why you overspend a

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

nd how you can stop. Cut those cards up and form a plan to get out of debt. Create a budget

.

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

and stick with it. Learn to live without the stress that comes along with debt. Sleep agai

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

Companies that provide selfless information through particip

n without worrying about how you will pay the bills. Free yourself from your debt addiction

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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