Advice Pool - Finance

Congress recently passed sweeping legislation that will significantly reform American bankruptcy law. Designed to eliminate

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

the “convenience bankruptcy” of compulsive gamblers and the financially irresponsible, this legislation will make it more d

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

Examples of combination products may in

fficult for those seeking bankruptcy protection from the courts to have their debts relieved.

Under current law, people who

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

have debts that they cannot repay may file under Chapter 7 of the Federal bankruptcy code, which allows nearly all debts to

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

be wiped away. The new legislation, which takes effect in October, 2005, will require most people filing for bankruptcy to

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

Combination pro

file under Chapter 13 instead. Chapter 13 requires that a repayment plan be established, usually over a period of five year

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

. Chapter 7 filings will still be an option, but the new legislation includes a “means test” that examines the filer’s inco

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

me to determine whether Chapter 7 or Chapter 13 is appropriate.

With the new law set to take effect, the number of people i

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

quiring about Chapter 7 bankruptcy filing has increased dramatically. Attorneys who specialize in bankruptcy law have repor

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

ted that their phones are ringing constantly, as people who are in financial trouble are wondering if they should file for b

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

nkruptcy immediately. While this is good for business, many attorneys are a bit concerned about the sudden rush to file fo

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

Following aspects would a

bankruptcy.

While filing for bankruptcy may be the only option for some people, it is not something to undertake in haste.

dd to the challenges in developing combination products:

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

Bankruptcy stays on your credit report for a minimum of ten years, and can your ability to obtain auto loans, mortgages or

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

even jobs in the future, even if you have established financial stability. Bankruptcy should not be entered into lightly,

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

and should be considered only as a last resort. Many creditors will work with those who owe them money, and it may be possi

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

le to establish a repayment plan without filing for bankruptcy.

If you feel that your financial situation is serious enough

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

Professional from academic institutions, pharmaceutical industries, health care indust

that bankruptcy is a possible option for you, you may wish to speak to a credit counselor or bankruptcy attorney now. Ther

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

are still five months remaining before the new legislation takes effect; this should provide most people with ample time to

.

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

examine their options carefully. What you should not do is rush into filing a bankruptcy petition that may turn out not to

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

Companies that provide selfless information through particip

be necessary. A rush to beat a five-month deadline may haunt you for ten years or more, and that is the last thing you want

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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Are you like many of the countless millions of consumers that are swamped with a large amount of consumer debt with no relief in site? Does your financial situation paint a picture of more bills then you can actually afford to pay?

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Advice Pool - Bankruptcy Interest Increases as Deadline Approaches

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