Advice You - Finance

In the US, a party can file for either Chapter 7 or Chapter 13 bankruptcy. In Chapter 7 or ‘st

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

raight’ bankruptcy, the applicant surrenders all non-exempt property and assets to an appointe

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

Examples of combination products may in

bankruptcy official. These are converted into cash and the proceeds are disbursed to the appl

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

icant’s creditors.

This process of liquidation then results in the applicant being freed of a

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

l financial obligations within a short period usually not exceeding four months. Obviously, th

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

Combination pro

is provision has seen a lot of abuse in the past. The new laws now state that an individual ca

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

not re-apply for Chapter 7 bankruptcy unless he/she has been given discharge from a previous f

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

iling for it for at least eight years.

In applying for Chapter 13 bankruptcy, the applicant i

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

dicates that he/she intends to repay his/her debts over a period of time. This period may vary

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

from three to five years. Chapter 13 bankruptcy is the preferred kind for applicants who cann

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

t prove complete and irreversible financial insolvency, meaning that they have a source of inc

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

Following aspects would a

ome that allows them to eventually settle their debts.

Chapter 13 bankruptcy also protects no

dd to the challenges in developing combination products:

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

-exempt property from liquidation and allows the applicant to retain ownership of it. The new

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

bankruptcy law amendments, effective from October 17, are oriented towards encouraging the max

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

mum possible repayment of debts and make it mandatory for certain applicants to file for Chapt

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

er 13 bankruptcy.

Chapter 11 or corporate bankruptcy is typically applicable to business enti

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

Professional from academic institutions, pharmaceutical industries, health care indust

ies that wish to restructure and reorganize. Chapter 12 or family farming bankruptcy was a var

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

iation formulated in 1986 is applicable to people or qualify as ‘family farmers’. Functionally

.

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

it is similar to Chapter 13 bankruptcy, except that its offers a higher debt ceiling than Cha

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

Companies that provide selfless information through particip

pter 13 does for wage earners to people or families who depend on farming for their livelihood

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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