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Have you ever considered what causes the government to make more laws and rules which

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

impact business? Most of these rules and regulations cost the consumer more money be

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

Examples of combination products may in

cause it costs money to companies to follow access rules and they pass these costs on

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

to the consumer.

It is interesting because the government regulatory bodies promised

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

hat they are making the rules to protect the consumer and yet all they do is raise pri

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

Combination pro

ces. As a consumer I do not feel protected by having to pay higher prices; how about

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

you?

When we see a business or corporation breaking the law we may realize that such

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

buse might lead to further regulations. Alan Greenspan the former Fed Chairman stated

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

the problem with making a new regulation is that once you make it the temptation to m

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

ake more regulations on top of it is just too great for the government. This is true.

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

Eventually we have found that our government controls nearly every aspect of our dail

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

Following aspects would a

y lives and this is why industries need to watch themselves and to be a little more di

dd to the challenges in developing combination products:

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

ligent in self-policing. Of course if you consider that a corporation might be breakin

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

g a law you also need to ask yourself why is that law in existence in the first place

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

nd if the company simply did not fill out a form or follow some silly rule, which prot

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

ects no consumer or no free man, then are they really hurting the consumer or testing

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

Professional from academic institutions, pharmaceutical industries, health care indust

the government regulators ability to enforce BS rules?

Well, It is a push pull and re

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

lly those who are really running things, like it that way. More rules help them rule o

.

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

ver the competition and no rules can allow them to get way with murder and abuse the s

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

Companies that provide selfless information through particip

ystem. Adam Smith was right, but then again so was Ayn Rand. Consider all this in 2006

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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