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In Australia, Matt and two friends went to a fast-food drive-through for lunch.

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

They wanted three separate orders as there were three in the car and no one had

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

Examples of combination products may in

xact change.

The order-taker replied, ‘I’m sorry sir, but we are only allowed t

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

process two drive-through orders at a time.’

‘But there’s no-one behind us,’ t

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

ey replied.

The order taker repeated, ‘I’m sorry sir, but we are only allowed t

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

Combination pro

process two drive-through orders at a time.’

The driver asked, ‘You mean I can

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

place two orders now, drive through and pick them up, then drive through again

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

o get my last order?’

‘That’s right,’ the order-taker said. ‘If you want more t

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

an two orders please come inside or drive through again.’

So Matt and his frien

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

s drove around the building to place their third order. In the time it took them

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

to drive around the building, not one other car appeared. It was a pretty small

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

Following aspects would a

building.

Matt spoke to the manager on duty who repeated the same comments: ‘Ou

dd to the challenges in developing combination products:

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

owner wants a maximum of two orders per car so we don’t slow down other custome

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

s.’ A noble decision, perhaps, but with one big flaw: there were no other custom

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

rs waiting.

Key Learning Point
------------------------------------

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

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Policies implemented for

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

Professional from academic institutions, pharmaceutical industries, health care indust

the good of the customers must be good for the customers, too.

Action Ste

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

s
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.

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

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Check your current policies in all areas of customer contact

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

Companies that provide selfless information through particip

nd concern. Look for lunacy, lost logic and loopholes. Make the changes required

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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