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This article has been written to provide some understanding to why we behave as we often do in organisations wit

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

hout understanding why we do things. How often have you had a response from someone when asked about something t

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

Examples of combination products may in

hey do – That is just the way we do things around here, or, that is as always as it has been and you can not cha

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

nge it.

As I understand it, the behavioural experiment performed went as this.

"Start with a cage containing f

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

ve apes. In the cage, hang a banana on a string and put stairs under it. Before long an ape will go up the stair

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

Combination pro

s and start to climb towards the banana. As soon as the ape touches the banana, spray all apes with cold water.

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

After a while, another ape makes an attempt with the same result - all the apes are sprayed with cold water. The

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

turn off the cold water.

"Now if another ape tries to climb the stairs for the banana the other apes will try

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

to prevent it even though no water sprays them.

Now remove one of the five apes from the cage and replace with

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

a new one. The new ape sees the banana and tries to climb the stairs. To his horror, all of the apes attack him.

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

After another attempt he is again attacked. He knows now that if he attempts to climb the stairs he will be assa

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

Following aspects would a

ulted.

"Next, remove another of the original five apes and replace with a new one. The newcomer goes to the sta

dd to the challenges in developing combination products:

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

irs and is attacked. The previous newcomer takes part in the punishment with enthusiasm. Again, replace a third

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

of the original five apes with a new one. The new one makes it to the stairs and is attacked as well. Two of the

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

four apes that beat him up have no idea why they were not permitted to climb the stairs, or why they are partici

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

pating in the beating of the newest ape. After replacing the fourth and fifth of the original apes there are no

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

Professional from academic institutions, pharmaceutical industries, health care indust

longer any apes that have been sprayed with cold water. Nevertheless, no ape ever again approaches the banana. W

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

y not ??

"Because that's the way it's always been around here."

That is how policy begins! This may be a somew

.

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

hat cynical viewpoint and I agree that not all policies are created with such a history. I do however suggest th

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

Companies that provide selfless information through particip

at many organisations have banana policies and procedures in place to this day or at least have such a viewpoint

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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