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The new bankruptcy law, officially known as The Bankruptcy Abuse Prevention and Consumer P

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

rotection Act of 2005, is aimed at making it more difficult for debtors to file for bankru

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

Examples of combination products may in

tcy under chapter 7.

Prior to the new law, which took effect on October 17, 2005, potenti

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

al filers could walk away from their debts after giving up most of their assets – which in

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

most cases were not substantial. The new bankruptcy law makes it tougher to walk away deb

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

Combination pro

t free.

One of the most important provisions of the law, requires debtors to pass the “me

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

ns test”. In summary, the test determines whether a bankruptcy filer has enough disposabl

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

e income to repay their debts. A person’s whose income exceeds that of their state of res

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

dence’s median income will probably not qualify, to file under chapter 7 but rather under

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

chapter 13. Chapter 13 sets up a repayment schedule for debtors to repay their debts - th

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

s debts are not forgiven but rather the filer has more time to pay them back.

Another sub

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

Following aspects would a

tantial change is that consumer credit counseling education is mandatory prior to filing f

dd to the challenges in developing combination products:

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

or bankruptcy. The counseling education must be acquired through a

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

http://www.poorcreditgenie.com/govtcounseling.html">government approved non-profit credit

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

counseling agency.

Lastly, shopping for a bankruptcy attorney may be more difficult.

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

he new law holds a filer’s bankruptcy attorney responsible for ensuring that the filing is

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

Professional from academic institutions, pharmaceutical industries, health care indust

legitimate. In fact, the attorney has to sign the petition and verify that it is “well g

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

ounded in fact”.

Also a bankruptcy attorney may not advise a filer on any matters that le

.

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

ads to the accrual of additional debts prior to filing for bankruptcy. It’s a catch-22 si

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

Companies that provide selfless information through particip

ce the act of filing for bankruptcy itself, will naturally lead a filer to incur more debt

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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