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The new balance of power in Washington, DC, has sent pundits scrambling to predict how the Republican Party and the Democratic Party will interact. Conservative pundits tout theories

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

that the Democrats will be forced to the political center, if not slightly to the political right by a conservative President Bush. Simultaneously, liberal pundits are celebrating 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 projected migration of a hawkish Executive Branch from the radical right to the conservative left. All this while our elected officials go to great pains to promise they will work

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

in the 'spirit of bipartisanism' and that there will not be 'gridlock' in Washington, DC.

In the disaster field office, we learned long ago that it is not business or even political

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

theory that insures the rapid inefficient movement of information and eliminates political or bureaucratic gridlock. The process that works best for eliminating gridlock and territor

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

Combination pro

ialism comes to us from a Harvard in the early 1980’s.

Gergen and Marcus described a concept in economics known as 'silozation'. In this groundbreaking theory the authors posit that

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

traditional business models allow for the progression of information from the base of the 'silo' up to the highest levels of management at the top of the silo or the dissemination 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

information from the top of the silo downward, but prevent communication between organizations (silos) through the wall at any middle level of management.

Gergen and Marcus state th

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

at silozation prevents the development of relationships between various professional organizations or even divisions within a single corporation. It also results in 'choke points' in

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

communications because information between organizations must be funneled through the top to the bottom of the silo before it could be disseminated to the other members of each organ

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

zation. Gergen and Marcus recommended that in business and economics the silos be cut down or totally removed. By doing this, organizations can communicate risk, benefit and opportu

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

Following aspects would a

nity, relying on their unique capability to insure customer loyalty and market success.

Commander Peter Marghella, USN (Ret.) has introduced this theory to the disaster field office.

dd to the challenges in developing combination products:

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

Commander Marghella correctly identified that individual professions within disaster medicine and individual organizations within emergency management maintained thick walled silos

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

that prevented cooperation and efficient in austere environments. The recommendations to remove the silos were impossible and cut through them where they could not be completely remo

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

ved has improved the efficiency in responding to disasters large and small.

Washington, DC and our nations elected officials need to remove their silos.

The artificial divisions cre

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

ated by classifying candidates as Republican or Democrat, conservative or liberal helps poorly educated voters select from often near identical choices. However, once elected, candid

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

Professional from academic institutions, pharmaceutical industries, health care indust

ates represent all of us and they must work with every other elected official in government, even if they do not agree with them. It is only by removing the silos that pen them in th

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

at our elected officials can do the work through which we, their constituents, have charged them.

Government is not a college football game and Washington, DC is not a bowl stadium.

.

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

Republicans and Democrats cannot and should not don partisan uniforms, strap on helmets and prepare to do battle. As the people who place them in office, we cannot sit on the home o

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

Companies that provide selfless information through particip

r visitor's side of the stadium, paint ourselves in our favorite team's colors and scream for the blood of our opponents. If we do, in the end, the blood on our hands will be our own

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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