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The Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 made it mandatory for all debtors to receive cr

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

edit counseling before they will be allowed to file bankruptcy. This credit counseling was made mandatory

; 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 ensure that all debtors understood their options before going bankrupt.

While it can be argued that credit counseling is a good

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

thing, there are also three dangerous credit counseling traps to be aware of if you are considering filing bankruptcy.

First, and m

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

ost importantly, your pre-bankruptcy credit counseling session must be completed within the 180 days prior to your bankruptcy filing

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

Combination pro

If you go to bankruptcy court to file bankruptcy, and you have not completed your credit counseling, you will not be permitted to

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

go bankrupt. Your bankruptcy petition will be dismissed.

Having your case dismissed means that you will not get relief from your 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

reditors. Obviously the purpose of going bankrupt is to prevent your creditors from taking any further legal or collection action a

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

ainst you, so having your case dismissed, simply because you did not attend a one hour counseling session, is a very serious trap.

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

Second, your credit counseling session must be completed by an approved credit counselor. Credit counseling services are approved b

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

the Department of Justice's U.S. Trustee Program, except in Alabama and North Carolina where court officials (known as Bankruptcy A

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

Following aspects would a

dministrators) approve pre-bankruptcy credit counseling services.

Before you agree to credit counseling, check the Department of Ju

dd to the challenges in developing combination products:

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

stice's web site to make sure that your counselor is on the approved list. There is little point in completing the counseling if th

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

credit counselor is not an approved credit counselor.

The third and final trap is that you must have proof of completion of your c

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

redit counseling for the court. Within 24 hours of the completion of your credit counseling you will receive a certificate of compl

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

tion. Only credit counseling organizations that have been approved by the U.S. Trustee Program may issue these certificates. As a

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

Professional from academic institutions, pharmaceutical industries, health care indust

fraud prevention measure, these certificates are sequentially numbered, and produced through a central automated processing system.

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

If you don't have the certificate of completion when you appear at your bankruptcy hearing, your case will be dismissed.

The bankr

.

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

ptcy process was already complicated, and the credit counseling requirement adds another level of complexity, so either do your own

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

Companies that provide selfless information through particip

research, or hire a competent bankruptcy attorney to represent you, so that you don't fall into one of these credit counseling traps

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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