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The new bankruptcy law is in effect, and the climate has drastically changed for people who are considering bankruptcy. In this article we will touch on some of the details of th

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

e new law, and explain exactly how these new changes will affect you.

First, let's touch on the new counseling requirements. According to the new law, you must complete credit c

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

Examples of combination products may in

ounseling with an agency approved by the United States Trustee's office before you can file for bankruptcy under either Chapter 13 or Chapter 7. Because this counseling is to deci

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

e whether you need to file for bankruptcy, or if an informal payment plan would be a better alternative for your situation. The counseling is mandatory for everyone, even for peop

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

le who know for certain that a repayment plan is not what they want.

However, you are required only to join in the counseling; you do not have to go with any repayment plans the

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

Combination pro

agency recommends.

But if you are given a plan, you will have to present the plan to the court with a certificate showing that you attended the counseling before you can file for

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

bankruptcy. Once your bankruptcy case is over, you will have to attend another counseling session focused on learning personal financial management skills to complete your bankrup

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

tcy and erase your debts.

Another major change that comes with the new law effects many people who want to file chapter 7 bankruptcy. Under the old law, most people filing could

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

choose between Chapter 7 and Chapter 13,and most people chose Chapter 7. Because of the new law, many filers with higher incomes will be prohibited from using Chapter 7.

The fi

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

st step in determining whether or not you can file for Chapter 7 is to compare your current monthly income to the median income for a family of your size in the state you live in.

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

In the context of the new law, your current monthly income is not your income at the time you file, but your average income over the last six months before you file.

Once you ha

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

Following aspects would a

ve determined your income, measure it against the median income in your state. If your income is equal to or less than the median, you can file for Chapter 7. If it is more than t

dd to the challenges in developing combination products:

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

e median, you must pass a requirement of the new law called the means test. The means test requires you to determine your amount of "disposable income" by subtracting different va

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

riables from your current monthly income.

If your current monthly income after subtracting these amounts is under $100, you pass the means test, and will be able to file for Ch

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

apter 7. If you income is more than $166.66, you will be prohibited from using Chapter 7. Those in the middle of these incomes will be able to file for chapter 7, but will be requ

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

red to still pay a percentage of their debt.

Yet another important change caused by the new law is that lawyers may be harder to find, and possibly more expensive. The new law ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

s added many complex requirements to the process of filing for bankruptcy that will make it more time consuming for lawyers to represent their clients in bankruptcy cases. The end

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

result being that attorney fees for representation will increase. Also, the amount of time that lawyers must put into the new regulations has increased and it is likely that it m

.

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

y be harder to find a lawyer that solely specialized in bankruptcy in the future. Many experts are predicting that the stress of these new requirements may drive some bankruptcy l

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

Companies that provide selfless information through particip

awyers out of the field completely.

Now that you know many of the changes the new bankruptcy laws hold for your situation, be aware and file with care.

Copyright 2006 Liz Robert

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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