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Many people who are overwhelmed with debt problems consider filing for bankruptcy. However, going bankrupt has a num

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

ber of serious disadvantages and should be avoided if at all possible.

In this article we will discuss why bankrupt

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

Examples of combination products may in

cy should be avoided and possible alternatives to filing for bankruptcy.

Getting into debt is easy, especially with

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

so many lenders offering you money via loans and credit cards. It is all to easy to run up huge bills when you are

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

charged high rates of interest on your un-paid debt. Before you know it creditors are pounding on your door and you

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

Combination pro

are too scared to open your mail. That’s when you think that bankruptcy might be the answer.

Contrary to popular mi

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

sconception however, going bankrupt does not mean that you do not have to pay your debts. It simply allows the court

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

to intervene and create a schedule for re-payment. Furthermore it opens you up to all sorts of penalties and disadv

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

antages.

For example, if you are declared bankrupt you may lose your home and you will be unable to obtain credit o

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

ver ?500. In addition to this, your bank accounts will be closed and you will have to hand over your credit cards to

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

the courts. If you have a business, your company will be closed down and your employees will be dismissed. Plus, in

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

Following aspects would a

the future you will not be allowed to be involved in forming, managing or promoting a company without the court’s p

dd to the challenges in developing combination products:

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

ermission.

There is also a huge social stigma associated with bankruptcy. This is because bankruptcies are announce

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

d in the local papers. So you will not be able to hide the fact that you have gone bankrupt.

So can you avoid bankr

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

uptcy? In 1986, the UK government introduced an alternative to bankruptcy called an IVA.

IVAs are formal and privat

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 agreements between a debtor and his creditors. In this agreement the debtor proposes to pay back an affordable amo

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

Professional from academic institutions, pharmaceutical industries, health care indust

unt of his debt each month.

In return the creditors write off a certain amount of the debt altogether and freeze in

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

terest on the debt. It is not unusual for as much as 85% of a debt to be written off and repayment amounts can be as

.

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

low as ?200 a month. After five years, if the terms of the IVA have been adhered to then the debtor is declared deb

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

Companies that provide selfless information through particip

t free.

An IVA is a good alternative to bankruptcy because there are no stigmas or disadvantages associated with it

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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