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I’m a bit amazed at this development but can certainly understand what is causing

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

this problem. The United States Mint recently acknowledged it is costing more 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

an one cent to produce a penny coin. Apparently the rising cost of metal has put

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

the penny in jeopardy.

According to Jeff Gore, founder of Citizens for Retiring

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

he Penny, it is currently costing 1.2 cents to put the penny into play. The grou

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

Combination pro

considers this ridiculous. I must admit, I too, see the hilarity in this situat

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

ion.

The Gallup poll shows that two-thirds of Americans want to keep the penny c

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

in. Of course they have not considered the rising cost to produce coins. Histor

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

cally coins have cost less to produce than the value paid by the banks who receiv

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

them. This made the process a money- maker for the government.

Since 1989 ther

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

have been efforts to cease penny production. A bill was introduced in Congress

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

Following aspects would a

to round off purchases to the nearest nickel. In 2002, the Gallup poll found tha

dd to the challenges in developing combination products:

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

fifty-eight percent of Americas save the pennies rather than spending them. Two

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

percent of the people polled stated they threw the pennies away.

Edmond Knowles

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

f Alabama saved his pennies for forty years. He actually collected 1.3 million o

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

them. This weights 4.5 tons. He had a very hard time getting rid of them. His

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

Professional from academic institutions, pharmaceutical industries, health care indust

banks said no to this. He requested Coinstar, a coin-counting company, take

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

he pennies. They sent an armored truck to his home and removed the pennies. Of

.

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

ourse, they enjoyed the publicity. Edmond received $13,084.59 for 4.5 tons of p

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

Companies that provide selfless information through particip

nnies!

Personally I enjoyed this story. It certainly fits my theme – Who Knew??

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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