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"After an Ohio State University convocation, the chairman ran out for an aspirin and the audience fell down laughing.

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

The Story: A distinguished old judge was invited to speak, the decision was made without realizing that the judge was somewhat e

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

Examples of combination products may in

centric and growing senile, He plodded to the lecture and started reading his typescript in a high, cracked voice.

When he got 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.

the bottom of Page One, he turned the page and continued reading. It soon became apparent that the judge was again reading Page

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

ne. And if that was not enough for the startled audience, the third page was Page One.

Everyone now realized that the materials

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

Combination pro

n the judge's hands were in triplicates. In all, seventeen pages were read three times over by the absent-minded old gentleman be

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

ore he got off the platform."
-- Paul Lee Tan

How embarrassing. How uncomfortable the audience must have felt.

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

ow they kept from laughing I'll never know. How could they sit through the entire lecture without doing something about the situa

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

ion?

How often do we find ourselves in the same situation? We know that someone needs help, but we feel helpless and hesitant. O

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

we know that something is wrong, dreadfully wrong, and yet we keep quiet . . . waiting for the ordeal to be over.

We see the sa

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

e thing in business. It's like the old children's story of The Emperor's New Clothes. Everyone knows there is a problem but they'

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

Following aspects would a

re afraid to speak. Someone knows that a new procedure has never worked for them, but they hold back. Fearing that they will be m

dd to the challenges in developing combination products:

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

de the fool, they do nothing. But in today's business world we can't do that. Doing nothing could be ruinous.

We can't afford pe

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

ple who are afraid to speak up. We can't afford to have ideas not shared. If we don't bring up problems that we see, we can't wai

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

for the runaway train in the market to destroy our company and our jobs. If one person with key information remains silent we ar

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

doomed.

Communication is the key to survival and change. And the key to that communication is trust. We need to know that our i

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

Professional from academic institutions, pharmaceutical industries, health care indust

eas will be listened to and be taken seriously. And we need to know that our comments, when given in good faith, will be free fro

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

retribution and rancor.

The emperor might not like being told he has no clothes, but it's certainly better to know that before

.

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

trolling among the masses.

The judge at Ohio State might have been embarrassed about reading his papers in triplicate, but if so

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

Companies that provide selfless information through particip

eone had stopped him and helped him reshuffle his papers, the people who gathered to hear his wisdom might have learned something

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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