Main Subject - Finance

For most people of course, bankruptcy is very much a last resort, to be considered only after all other debt consolidation and

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

debt reduction options have failed. Even so, the new bankruptcy laws passed in 2005 mean that filing for bankruptcy is now muc

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

Examples of combination products may in

h more complicated, and for many people much more expensive that it had been before the new laws went into effect.

Just what h

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

as changed?

Perhaps the biggest change that was instituted in the world of bankruptcy laws is the introduction of a two part m

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

eans test. The results of this means test are used to determine which of the two forms of bankruptcy the individual must use.

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

Combination pro

The first part of the means test uses a formula to find out if the individual can afford to pay at least 25% of the non-priori

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

tized unsecured debt that is owed. This non-prioritized unsecured debt includes debt such as credit cards. The formula takes

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

into account and exempts necessities like food and rent, but it can be fairly restrictive.

The other part of the new means tes

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

t is to compare the income of the bankruptcy filer to the median income for his or her state. Those who are found able to pay

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

back at least 25% of the unsecured debt they owe, and whose income exceeds the state median, will be required to file for bankr

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

uptcy under the more restrictive Chapter 13 law, and they will be ineligible for the more generous rules of a Chapter 7 filing.

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

Following aspects would a

What’s the difference?

There are considerable differences between the two forms of bankruptcy filing, and the difference can

dd to the challenges in developing combination products:

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

add up to thousands of dollars. With a Chapter 7 bankruptcy filing, the debtor has all of his or her assets, except for those

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

which are exempted by the state, liquidated, and the proceeds are used to pay off the creditors. If the amount of debt exceed

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

s the proceeds of the assets, the remaining debts are cancelled, leaving the creditors holding the bag.

With a Chapter 13 bank

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

ruptcy filing, on the other hand, the debtor is required to complete a court mandated payment plan, lasting up to five years.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Any debts that have not been repaid by the end of that predetermined period are cancelled.

As you can see, the Chapter 13 bank

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

ruptcy filing is quite a bit more restrictive, and it typically means that a greater percentage of the total debt must be repai

.

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

d. It is important for any debtor considering a bankruptcy filing to look at his or her own situation, and apply the means tes

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

Companies that provide selfless information through particip

t to determine which filing status he or she is likely to fall into. Being an informed consumer has never been more important.

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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