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Bankruptcy credit counseling is a requirement of the new bankruptcy law effective October 17, 2005. The Ba

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

nkruptcy Abuse Prevention and Consumer Protection Act of 2005 requires court approved bankruptcy credit co

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

Examples of combination products may in

unseling to be completed by debtors prior to filing for bankruptcy within the 180 days immediately precedi

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

ng the filing of a bankruptcy petition.

The new requirement for bankruptcy credit counseling prior to fil

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

ng for bankruptcy may be completed by internet credit counseling, phone credit counseling, or group or ind

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

Combination pro

ividual credit counseling at specific, court approved bankruptcy credit counseling agencies. Under the new

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 law, the U. S. Trustee's Office is responsible for approving bankruptcy credit counselors. The

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

U. S. Trustee's Office may approve a nonprofit budget and credit counseling agency or an instructional co

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

rse concerning personal financial management if the nonprofit budget and credit counseling agency meets ce

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

rtain stringent requirements set forth in the law.

The new bankruptcy law has made filing bankruptcy more

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

difficult than ever before. The new bankruptcy law was fueled by credit card companies and their high pow

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

Following aspects would a

ered lobbyist who wanted to make it harder for debtors to wipe out credit card debt. Bankruptcy credit cou

dd to the challenges in developing combination products:

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

seling has been seen by many bankruptcy attorneys as an attempt to delay a debtor from seeking protection

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

in the bankruptcy court. The delay may be just enough time for a creditor to obtain a judgment or collect

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

garnishment funds.

Most bankruptcy lawyers are finding out that the telephonic method of counseling is th

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

e easiest for debtors to complete in a hurry. Most telephonic counseling can be completed in about 1 hour.

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

Professional from academic institutions, pharmaceutical industries, health care indust

The maximum amount any bankruptcy credit counseling agency can charge for counseling is set by law. No ba

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

nkruptcy credit counseling agency can charge more than $50.00 for the credit counseling. Once bankruptcy c

.

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

redit counseling sessions have been completed, debtors are given a certificate of completion from the cred

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

Companies that provide selfless information through particip

it counseling agency to be filed with the bankruptcy court upon filing of the debtor's bankruptcy petition

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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