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When an individual or a business faces difficult financial times, it often becomes necessary to consider filing for bankruptcy protection. In order to assist in selecting the best bankruptcy option for a client, the ef

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

fective advocate must be aware of and understand the advantages or disadvantages in choosing one bankruptcy selection over another. Generally speaking, bankruptcy allows people who are unable to pay all bills due to get

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

Examples of combination products may in

a fresh start by jumping through various procedural obstacles. There are four kinds of bankruptcy protection provided for by statute:

Chapter 7: known as "straight" bankruptcy or “liquidation.” Chapter

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

7 requires that a debtor give up property which exceeds certain limits so that the property can be sold to pay creditors.

Chapter 11: known as a “reorganization.” Chapter 11 is used by businesses and some

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

individual debtors whose debts are very large.

Chapter 12: is reserved for family farmers.

Chapter 13: known as a "wage earners plan.” Chapter 13 requires a debtor to file a plan to pay debts (o

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

Combination pro

parts of debts) from current income. Most individuals who can afford to make some payments to creditors will elect Chapter 13 bankruptcy protection. When filing for Chapter 13 bankruptcy, the individual fil

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

es an interest free debt repayment plan, generally over a 3-5 year period, which consolidates (and often reduces) the debt, and must be approved by a federal bankruptcy court. While in a Chapter 13 debt repayment plan,

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

creditors are barred from collecting, and they are required by the presiding Court order to adhere to the terms of the plan. To qualify for Chapter 13 though, the individual must be working or have a consistent source

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

of income that will allow them monthly living expenses in addition to the required debt payments.

The repayment plan is the centerpiece of Chapter 13 bankruptcy, and is essentially an agreement between an individual a

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

d their creditors. The creditors usually agree to forgive a portion of the debts owed them in exchange for a commitment to repay the reduced debts over time. Most plans require monthly payments to the bankruptcy truste

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

e, which is a federal official appointed by the court to oversee the case. The trustee then makes distributions to the creditors. While making payments under a repayment plan, the creditors listed in that individual’s p

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

Following aspects would a

lan cannot take any collection actions against them, and they are required by law to abide by the terms of the repayment plan.

An online creditor’s ability to collect money after the initiation of a Chapter 13 filing b

dd to the challenges in developing combination products:

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

the debtor, like other creditors, will largely depend on the nature of the debt. Due to the speed and anonymity of electronic commerce, most online creditors will be unsecured. In order to participate in the bankruptc

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

y process to ensure some level debt recovery, any unsecured creditors must file their claims with the court within 90 days after the first date set for the meeting of creditors. With general creditors this does not pre

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

ent an issue, but because of jurisdictional barriers created by electronic commerce, this requirement is often not met.

An online creditor must exercise an extra level of due diligence when attempting to collect on pas

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

t due accounts. While Chapter 13 requires that a debtor list all debts and creditors at the beginning of the process, it is possible for a creditor to not be notified due to distance or other jurisdictional issues. Fa

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

Professional from academic institutions, pharmaceutical industries, health care indust

lure to take notice of a claim may preclude the creditor from collecting any of the money due.

Chapter 13 is often a viable alternative to Chapter 7 bankruptcy for those people who can maintain a certain level of incom

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

e. Whether attempting to collect on a Chapter 13 bankruptcy filing, or contemplating seeking the protection offered by filing, only an experienced bankruptcy lawyer can accurately guide you through the difficult proces

.

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

. A qualified bankruptcy attorney is both the creditor’s and the individual’s most useful tool in being able to navigate the bankruptcy process. As electronic commerce continues to expand, Chapter 13 online creditors

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

Companies that provide selfless information through particip

will only increase in proportion. Due to the unique obstacles and challenges presented by the online creditor collection process, an experienced attorney may be the only way to ensure Chapter 13 protection or collection

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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