Answers - Legal

It is amazing sometimes the way that our Federal Regulators operate

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

, as they prevent some industries from consolidating and due to pol

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

Examples of combination products may in

itical pressures disallow others. Indeed the business office supply

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

business is completely competitive and the move by Staples to acqu

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

ire Office Depot should have been allowed because Staples early on

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

Combination pro

could not get the funding needed to expand as fast a Office Depot.

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

Staples runs a tight ship and needs more locations for economies of

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

scale and to compete with Office Max, Corporate Express and online

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

Office Supply companies.

The Federal Trade Commission rather than

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

understanding the dynamics of the industry and the reality of the

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

market place and its history has yet totally botched another deal,

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

Following aspects would a

which is needed to help the consumer and industry work towards serv

dd to the challenges in developing combination products:

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

icing the market place. Without the Office Depot Staples merger the

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

consumer will be harmed with less service in the Office Depot Stor

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

es as they cut thousands of jobs.

The Federal Government regulator

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

s in the opinion of many analysts reviewing this proposed merger is

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

Professional from academic institutions, pharmaceutical industries, health care indust

yet another example of poor management? And may I ask what a few 2

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

6 year old type reviewers and government regulators know about offi

.

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

ce supplies? Heck the government wastes more money on paper clips p

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

Companies that provide selfless information through particip

er year than the amount of this merger deal. Consider 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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