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On October 17, 2005 the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 (BAPCPA

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

) went into affect. This law was the most sweeping change ever to bankruptcy in the United Sta

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

Examples of combination products may in

es. The interesting thing about the name of the act is that it was grossly misnamed in that it

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

does little to prevent abuse, and does even less to protect consumers. See Attorney Brett Weis

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

' article "How Will the New Bankruptcy Law Affect Me?" for a more complete list of changes to b

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

Combination pro

nkruptcy.

Despite that the law did change, do not believe the debt collectors who may tell you

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

that bankruptcy is no longer available to you. The fact is that if you are struggling to pay y

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

ur debts, you will qualify to file some form of bankruptcy.

The basic concept in bankruptcy is

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

that the system is based on equity. That is to say that rulings in a bankruptcy court are supp

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

sed to be based on what's fair. Therefore, if you truly cannot pay your debts, it would not be

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

fair to force you to do so. BAPCPA may disqualify few people who may have qualified for a Chap

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

Following aspects would a

ter 7 bankruptcy before the law changed, but Chapter 13 bankruptcy is still available to almost

dd to the challenges in developing combination products:

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

every individual as long as the debts do not exceed certain limits -- $336,900 of unsecured deb

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

and $1,010,650 of secured debt. (For a list of commonly used bankruptcy terms see my

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

http://www.bankruptcyvictoriatexas.com/bankruptcyglossary.html" target="_blank"> glossary)

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

Under most circumstances, completing a Chapter 13 bankruptcy will eliminate most of a person'

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

Professional from academic institutions, pharmaceutical industries, health care indust

unsecured debt interest free, and in many cases, completing a Chapter 13 bankruptcy will enti

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

ely eliminate all of a person's unsecured debt without payment of any kind toward those debts.

.

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

If you think that you may need to file a bankruptcy, make an appointment with an attorney near

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

Companies that provide selfless information through particip

you who actively practices bankruptcy in order to get advice that is specific to your situation

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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