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Many Industry analysts who study the on-going push-pull between Multi-National Conglomerates and th

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

eir Labor Unions understand the history behind organized labor. Many believe that in the 1930’s tha

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

Examples of combination products may in

t labor unions were needed and until up into the 1970’s most everything was unionized especially 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.

the East Coast.

In looking at the unions in the 1980s and 1990s we see how Unions hampered compani

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

es and thus made them un-competitive. This caused companies to reduce in size, which meant they nee

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

Combination pro

ed fewer workers, the exact opposite of what the Unions had wished for.

One intellectual recently

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

stated on this issue; “I still believe something has to be done about the unions, if you could trus

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

corporate America to do the right thing by their employees I'd say unions be damned. But who woul

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

d monitor corporate America?”

This is an interesting comment in that Corporate America is so utter

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

y over regulated and must defend itself from a barrage of attacks from things like Sarbaines Oxley

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

and the political exploits of folks like Elliot Spitzer. So many still blame Corporate America and

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

Following aspects would a

side with the Unions. Others believe the Unions have served their useful life in Free-Enterprise.

dd to the challenges in developing combination products:

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

ndeed, it does not matter who started it, there is a divide there. And labor currently has some lev

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

erage with unemployment so low, but they exercise their leverage in vindictive and underhanded ways

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

and use government to attack businesses. No one wins. It is like cutting off the hand that feeds yo

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

u to the benefit of those who off shore jobs or foreign competition.

We need to get Corporate Amer

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

Professional from academic institutions, pharmaceutical industries, health care indust

ca and Union Labor on the same page without attacking if our modern companies are to compete. Corru

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

ption is unfortunate on either side. Executive Management or Labor Unions, the bigger issue is the

.

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

thics in the US. And when we attack each other the team scores less home runs and the fans get rath

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

Companies that provide selfless information through particip

er disenchanted. It is time to bury the hatchet and resolve to work together. 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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