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DECISION BY AUTHORITY RULE: Many groups start out with—or quickly set up a power structure that makes it clea

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

r that the chairman (or someone else in authority) will make the ultimate decision. The group can generate ideas

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

Examples of combination products may in

and hold free discussion, but at any time the chairman can say that, having heard the discussion, he or she has

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

decided upon a given plan. Whether or not this method is effective depends a great deal upon whether the chairma

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

n is a sufficiently good listener to have culled the right information on which to make the decision. Furthermor

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

Combination pro

, if the group must also implement the decision, then the authority-rule method produces a bare minimum of invol

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

vement by the group (basically, they will do it because they have to, not necessarily because they want to). Hen

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

e it undermines the potential quality of the implementation of the decision.

DECISION BY MINORITY RULE: One of

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

the most often heard complaints of group members is that they feel “railroaded” into some decision. Usually, th

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 feeling results from one, two or three people employing tactics that produce action—and therefore must be cons

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

idered decisions—but which are taken without the consent of the majority. A common form of minority rule is for

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

Following aspects would a

two or more members to come to a quick and powerful agreement on a course of action, then challenge the group wi

dd to the challenges in developing combination products:

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

h a quick “Does anyone object?", and, if no one raises their voice in two seconds, to proceed with “Let’s go ahe

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

ad, then.” Again the trap is the assumption that silence means consent.

DECISION BY MAJORITY RULE (VOTING AND/O

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

POLLING): More familiar decision-making procedures are often taken for granted as applying to any group situati

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

on because they reflect our political system. One simple version is to poll everyone’s opinion following some pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

iod of discussion. If the majority of participants feels the same way, it is often assumed that that is the deci

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

sion. The other method is the more formal one of stating a clear alternative and asking for votes in favor of it

.

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

votes against it, and abstentions. On the surface this method seems completely sound, but surprisingly often it

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

Companies that provide selfless information through particip

turns out that decisions made by this method are not well implemented, even by the group that made the decision

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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