Advice You - Finance

Bankruptcy is a legally declared inability of individuals or businesses to discharge their debts. A de

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

clared state of bankruptcy can be requested not only by creditors in an effort to get what they are ow

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

Examples of combination products may in

d but also by the insolvent individual or organization. If it is difficult to repay debts, declaring t

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

he bankruptcy may be the right solution to debt problems.

Out of six basic types of under the Bankrup

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

cy Code, Chapter 7 is a “liquidation” of nonexempt assets to pay debts. In a court-supervised procedur

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

Combination pro

e, a court appoints a trustee who liquidates the non-exempt assets of the debtor’s estate and makes di

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

tributions to creditors. The Bankruptcy Code allows the debtor to keep certain exempt property; but a

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

trustee will liquidate the debtor's remaining assets.

According to the amendments to the Bankruptcy C

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

de enacted in to the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005, if a debtor’s in

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

come is in excess of certain thresholds, the debtor may not be eligible for chapter 7 relief. Filing a

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

petition under chapter 7, automatically stays most collection actions against the debtor or the debtor

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

Following aspects would a

s property, but potential debtors should realize that the filing of a petition under chapter 7 might r

dd to the challenges in developing combination products:

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

esult in the loss of property.

After Chapter 7 bankruptcy, one will not longer owe money on credit ca

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

ds, unsecured loans, unpaid hospital, medical and utility bills and unpaid rent. But debts like state

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

and federal taxes (unless they are more than three years old), child support required by law; alimony,

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

government-backed student loans, debts due to fraud, fines, penalties and debts due to willful injury

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

Professional from academic institutions, pharmaceutical industries, health care indust

to another person or property are not eliminated by Chapter 7 bankruptcy.

Just a few months after the

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

petition is filed, in most chapter 7 cases, the individual debtor receives a discharge that releases d

.

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

ebtor from personal liability for certain dischargeable debts. Thus, chapter 7 Bankruptcy is designed

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

Companies that provide selfless information through particip

o give the debtor a new start and a chance to live with sound financial management. Finance:Bankruptc

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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