Advice You - Business

Every month I receive messages from students and readers that begin, ‘I got such terrible service

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

from…’ and often close, ‘…and I’ll never go back there again!’

I find these stories upsetting,

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

Examples of combination products may in

ccasionally entertaining, but rarely are they motivating or instructive.

Here’s why:

Anyone wit

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

enough intelligence and emotion to muster a written complaint also has the ability to offer a co

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

structive solution. If you can see what’s wrong with a situation, you must have some idea about w

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

Combination pro

hat would set it right.

Noticing problems is half the puzzle; getting things improved is the mor

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

important part.

If you are upset with a vendor, colleague or business partner, you must have so

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 expectations unmet, some needs ignored or some preferences overlooked.

Your view of the situat

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

on is unique and your perspective may be very useful to the other party. Clearly stated, your req

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

uests and recommendations could make a difference.

Unless you enjoy complaining for its own sake

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

follow these five simple steps to help everyone improve.

How to complain for action

1. State y

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

Following aspects would a

ur original understanding, including the promise you heard and the standards you expected.

2. Id

dd to the challenges in developing combination products:

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

ntify the flaw, gap or oversight you experienced.

3. Explain the consequences you have suffered:

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

costs, anxiety, adverse impact.

4. Request specific remedial action and/or compensation.

5. Ma

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

e a suggestion for improvement. Help the other party do a better job the next time.

Key Learning

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

Point
--------------------------------------------------------------------------------

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

Professional from academic institutions, pharmaceutical industries, health care indust

You have the right to complain when things do not work out as you expected. But complaining is on

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

ly half the job. You also have a responsibility to contribute.

Action Steps
--------------

.

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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The next time something go

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

Companies that provide selfless information through particip

s wrong and you want to `give someone a piece of your mind', make sure that piece is constructive

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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