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There is a big debate out there as whether the States Attorneys Generals actually h

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

elp consumers and investors from fraud. If a company makes an error in a disclosure

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

Examples of combination products may in

document, form or filing, is it automatically fraud? Or simply a mistake in a sea

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

of over regulation and impossible stipulations that we know are stifling free-enter

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

rise.

When an Attorney General files a lawsuit on a company and that company is ma

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

Combination pro

de to pay, then those extortion fines are in fact passed on to future consumers and

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

therefore who did it really help? We know it helps Attorney Generals with politica

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

aspirations pad their resumes to run for higher office, yet who does this really s

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

erve?

Some say if the Attorneys General does not serve the taxpayer then that; "At

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

torney general is not going to make an effort to check to see if there is a problem

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

eliminate the position." And others say;

Well, the Attorneys General is busy with

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

Following aspects would a

other things I suppose and remember it is a VERY political position too. Well they

dd to the challenges in developing combination products:

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

are Lawyers and Lawyers are paid to lie, that is their job! That is why so many ru

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

n for political office. But alas are they are too busy commandeering the plastic sh

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

vels and telling the teacher they need next years budget for more plastic shovels a

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

nd Sand Castle plastic molds.

One has to ask these questions and wonder with all t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hese issues, surely we can do a better job in our government to protect the consume

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

and not harass the business community. Otherwise we really do not need these folks

.

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

in our government, as they serve no interests but their own. Consider all this in

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

Companies that provide selfless information through particip

2006 and the flip side, what would happen if they were eliminated and did not exist

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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