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Main Subject - Negotiation Tactic -- Take It Or Leave It
How many times have we heard this commonly used negotiation tactic? T
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
he “take it or leave it” tactic is basically an ultimatum designed to
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
prevent further negotiations from taking place. It is almost always a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
bluff and a challenge to the other side to see who has the stronger n
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
erves. The problem with this tactic is that it causes too much resist
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ance and conflict to facilitate an agreement. This tactic is aggressi
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
ve and demanding, two things that don’t sit well with your counterpart
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
. What you are basically saying with this tactic is, “Its going to be
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
my way, or no way.” Now the other side is going to have to reassert
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
their own dominance over the situation by choosing to “leave it” rathe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r than to “take it” to save face and show you who really is in charge.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
Where is the negotiation now?
How To Counter This Tactic
There are
How To Counter This Tactic
There are
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
three main ways you can counter the “take it or leave it” tactic. Th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e first way is by simply ignoring it. Let it fall on deaf ears and ju
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
st continue negotiating like you never heard it. This lets you test t
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
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
he seriousness of their threat. The second way is by asking them, “Wh
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
at do you think might happen if we don’t reach an agreement.” This wi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ll get the other side to realize the consequences of not reaching a ne
.
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
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
gotiated settlement. The third way is by probing more into their inte
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
rests and needs on the issue rather than focusing in on their demands.
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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