Main Subject - Business

We have all heard horrendous stories of how over regulation crushes small busi

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

ness people who compete with the big dogs in various markets. It seems as if t

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

Examples of combination products may in

he government regulators are merely there to crush the little guy sometimes so

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

that the big boys with lobbyist budgets can get the government to intervene v

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

a some Congressmen, Councilman, Senator, Corrupt Judge or County Supervisor.

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

Combination pro

Well here is a story that is truly outrageous indeed; a total abuse of the sys

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

tem, but the Sierra Club. You see, I met someone recently who owned a mine in

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

ust North of Albuquerque in the hills about Santa Fe, New Mexico. Get this, he

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

had a ten-mile road and the Sierra Club was made because he owned a mine.

He

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

never mined anything just loved the landscape and was able to use his retirem

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

nt money and got the property for a song. He was planning on building his drea

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

Following aspects would a

m home there in fact. So the Sierra Club filed a lawsuit stating that the rule

dd to the challenges in developing combination products:

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

s and regulations said that he had to water the dirt road. He lived outside of

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

Midland, TX a state away, but told me of this story in Starbucks Coffee shop

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

n Santa Fe.

Turns out the cost to water the road once a day for a year was as

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

tronomical due to water shortages in New Mexico, costs and remoteness for the

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

Professional from academic institutions, pharmaceutical industries, health care indust

water truck, 5 loads to water the road. So he paved it, but the Sierra Club pr

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

ssed the lawsuit so now he waters a paved road in the middle of the biggest dr

.

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

ought in the history of New Mexico? Now that helps the environment? Dah? True

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

Companies that provide selfless information through particip

Story, one of thousands and so I hope this article will propel thought in 2007

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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