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Since the court case was over turned against Arthur Anderson in the Enron scandal, the United States Government owes A

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

rthur Anderson sixteen billion dollars. This money should be taken out of the Justice Departments fund for pensions fo

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

Examples of combination products may in

all the government workers and paid to the damaged Arthur Anderson partners. The business community is waiting for a

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

response to see if the Justice Department and the United States government will walk the talk and pay for these damage

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

and do the right thing.

It is a complete travesty that the United States government refuses to own up to its abuses

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

Combination pro

which it knew or should have known was against the laws that they created thru their unending over regulation of the p

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

ivate sector. What we have here is a complete disregard for the free enterprise system and a selective prosecution app

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

roach riding on the political whim of the moment steered by mass media incited hysteria and poles. Those prosecutors a

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

d investigators who are utopia-ists are destroying any chance of getting there. We seem to have a complete disregard a

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

t the Justice Department for law and an utterly and complete level of incompetence with regulations and opinions of su

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

h regulations, which have absolutely no bearing on the reality of the law.

How can we trust an agency, which disrespe

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

Following aspects would a

ts the laws they create? How can the business community trust the government not to steal the hard earned brand name o

dd to the challenges in developing combination products:

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

f companies in a blink of an eye under the whims of speculative interpretations of law? Houston we have a problem alri

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

ht but it ain’t the business community, it is the over regulation and selective prosecution of government regulators w

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

ho lack the cranial capacity to serve the people.

When is the United States Government going to pay the former partne

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 of Arthur Anderson the sixteen billion dollars they owe? When can they expect that check? And when the United Stat

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

Professional from academic institutions, pharmaceutical industries, health care indust

es Government cuts the check; why should we the tax payer bear the burden? It needs to come out of the pensions of all

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

those in government forthwith. The government workers who lack integrity or respect for the law should pay the price,

.

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

just like those 28,000 partners at Arthur Anderson already paid for a crime that was never committed? Think about it,

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

Companies that provide selfless information through particip

he time for change is now; the train is leaving the station and we need to know whose side the government is really on

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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