Advice Pool - Finance

The recently passed Bankruptcy Abuse prevention and Consumer Protection Act will make it harder for people with problem debt

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

to have their debt eliminated through filing for bankruptcy. This new legislation will make it harder to have debts wiped

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

Examples of combination products may in

out by the courts, and will require more debtors to pay back some or all of their debts. Considered by many to be a gift fr

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

om Congress to the major credit card companies, this new law has many people rightly concerned about how to best deal with t

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

heir debt problems. An additional concern that few have considered is that it not only will be more difficult to file for b

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

Combination pro

ankruptcy, it may also be difficult to find legal assistance once the new law takes effect in October, 2005.

Under current

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

law, filing for Chapter 7 bankruptcy for consumer debt is a fairly routine procedure. A Chapter 7 filing allows most debts

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 be eliminated once the debtor demonstrates that they cannot pay their bills. While it is and should be considered a last

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

resort for those in debt, a Chapter 7 filing allows those who emerge from bankruptcy to have a “fresh start.” Legal costs

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

vary for assisting with a Chapter 7 filing, but they typically involve only a few hours of billing time on the part of an at

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

torney. Under the new legislation most filers will be forced to file for bankruptcy under the more complicated Chapter 13.

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

Following aspects would a

A Chapter 13 filing, which requires the structuring of a repayment plan, is somewhat more complicated and generally costs tw

dd to the challenges in developing combination products:

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

o to three times as much in legal fees. Adding to the complication is the fact that the new legislation will hold the atto

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

rneys for those filing for bankruptcy liable for paperwork issues, leaving the attorneys vulnerable to lawsuits from both ba

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

nkruptcy trustees and the customers on whose behalf they file.

What this means to the consumer is that good legal help will

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

be expensive and hard to find once the new bankruptcy law takes effect. Attorneys who specialize in bankruptcy cases will u

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

Professional from academic institutions, pharmaceutical industries, health care indust

ndoubtedly raise their rates significantly in order to offset their greater risk. Attorneys who seldom work on bankruptcy c

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

ases may simply stop handling them, thinking that the additional risk of a lawsuit isn’t worth their trouble. Anyone who is

.

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

currently experiencing debt problems, which might require the help of a bankruptcy attorney, should probably meet with one

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

Companies that provide selfless information through particip

now. It is better to find one now, even if you don’t need one, than to need one later and realize that you cannot find one.

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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