Advice You - Finance

Most people file under chapter 7 bankruptcy law because of the three main reasons:

1. It is much faster then the other chapters. With a lit

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

tle effort on your side, you can have the entire process over in next four to six months.

2. It is also simpler to file. No frequent visits

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

Examples of combination products may in

to court are required.

3. There are no after payments. Once your bankruptcy is discharged that is it, you are debt free. (Under the 2005 c

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

apter 7 bankruptcy law not all debts can be discharged anymore so consult with your attorney before filling).

On the other hand, chapter 7

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

bankruptcy law has a catch, the court will decide whether you are allowed to file for it or not. One of the main reasons why you can be deni

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

Combination pro

d to file for chapter 7 is your income. If it happens to be sufficient to payoff some of your debts (after your allowed living expenses have

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

been counted in) then you might be forced to file under chapter 13 bankruptcy law.

How to check if you can apply for filing under chapter

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

bankruptcy law?

First thing you need to do is to calculate your average earnings in the last 6 months and compare it with average income f

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

or the state you live in. You will be allowed to file under chapter 7 bankruptcy law if your income happens to be lover or the same as the m

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

dian income of the state you live in.

In case that your average income is higher than that, and you still want to apply for chapter 7 bankr

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

uptcy law you will have to go through one more test called the Means Test.

So what is a means test?

It is a test based on the results calc

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

Following aspects would a

ulated for your allowed living expenses.

How to calculate my living expenses and what can I include in it?

It is actually quite easy to ca

dd to the challenges in developing combination products:

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

culate it. Take all your income from one average month and deduct the following allowed expenses:

1) Utility bills, transport (gas), food,

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

clothing. (Make sure to use IRS amounts for these or the court will not take it in to account).

2) Your secured monthly payments like child

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

support, car loan, mortgage and tax.

After you finish with the calculation and your average disposable income per month is lover then $100,

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

you have passed the means test and you stand a fair chance of being approved to file for bankruptcy under chapter 7 bankruptcy law.

If on

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

Professional from academic institutions, pharmaceutical industries, health care indust

he other hand your disposable income happens to be more than that (figure most often mentioned is $166, but it can vary), you will most like

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

ly have to file under chapter 13 of the bankruptcy law. That is unless you can provide evidence that there are some special considerations t

.

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

be taken in your account.

For any figures between $100 and $166, it is best to consult with your attorney. To improve your chance for fili

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

Companies that provide selfless information through particip

ng under chapter 7 bankruptcy law make sure to find an attorney that specialize in bankruptcy and credit repair and has the solid reputation

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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