Main Subject - Finance

Many times the subject of bankruptcy seems baffling in its complexity. Actually the basic principals of bankruptcy are fairly

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

simple even though the federal statuses on bankruptcy are extensive. The reason that the statutes are so complex is because in

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

Examples of combination products may in

as effort at social engineering, the lawmakers want to cover every possible contingency. The very complexity of the Bankruptcy

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

Code gives the lawyers ample opportunity to try to obtain interpretation of the law which best serves their clients interest.

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

This results in extensive litigation and occasionally in interpretations of the Code which were not what legislature intended.

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

Combination pro

This on turn results in additional legislation, which results in additional litigation and on and on. Nevertheless, the underl

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

ying principals are not as complex as the Code makes them seem. Here we will discuss the personal nature of bankruptcy.

The 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

ncept of bankruptcy is an old one in the English common law. If a person could not pay his debts, his creditors hauled him int

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

court, took all of his assets, and used those assets to satisfy their debts. If the assets were insufficient to satisfy the d

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

ebts, the debtor was taken from the bankruptcy court to debtors' prison. Since this is a rather extreme remedy, Article 1 Sect

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

on 8 of the U.S. Constitution gives the Congress the right to establish "?.uniform Laws on the subject of Bankruptcies through

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

Following aspects would a

ut the United States."

As the popularity of debtors' prison declined, the concept of giving the debtor a fresh start became o

dd to the challenges in developing combination products:

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

ne of the primary purposes of the bankruptcy process. It is important to remember that a bankruptcy is a personal action which

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

at time of discharge gives the petitioner (formerly the debtor) a fresh start. The property owned by the petitioner does not g

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

t the fresh start, the individual does.

The fact that bankruptcy is a personal action may shed some light on the effect of a

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

homestead exemption in a bankruptcy proceeding. The bankruptcy code acknowledges the validity of homestead exemption. A homest

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

Professional from academic institutions, pharmaceutical industries, health care indust

ad exemption is a personal exemption which, in an effort to preserve a person's home, protects a certain amount of an individu

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

l's equity in the homestead property. State law determines the extent and effect of a homestead exemption. Thus, if state law

.

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

says that a person can declare a homestead up to $45,000 and if there is less than $45,000 equity in the property, that equity

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

Companies that provide selfless information through particip

in the property is protected by the homestead exemption. This principal operates without regard to the Federal Bankruptcy Code

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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