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On April 20, 2005, President Bush signed into law the Bankruptcy Abuse and Consumer Protection Act, a piece of sweeping legislation that brou

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

ght about the most sweeping changes in personal bankruptcy law in the

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

Examples of combination products may in

last quarter century. This bill, which takes effect in October 2005, passed with the overwhelming support of both parties of congress, claim

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

s, through its very name, to offer “consumer protection.” Does it? How are consumers “protected” by this bill?

The purpose of the new legi

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

lation, is to eliminate “bankruptcy of convenience”. Sponsors of the bill allege that most consumer bankruptcy cases involve irresponsible s

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

Combination pro

penders who have shopped or gambled their money away and now do not wish to pay their creditors. They rightly point out that bankruptcy cost

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

the credit card companies billions of dollars each year and that those costs are passed on to consumers in the form of higher interest rates

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

. By making it harder for those with problem debt to file for bankruptcy, legislators say that more people will pay their bills, the credit

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

ard companies will save billions of dollars, and the resulting savings will be passed on to consumers in the form of lower interest rates.

T

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

he bill is lengthy, but key points are as follows:

Those considering bankruptcy will have to pass a “means test.” If their income is ab

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

ve a certain threshold, they will not be able to file under Chapter 7 of the Federal bankruptcy code, which wipes out debt and gives the debt

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

Following aspects would a

r a fresh start. Instead, they will have to file under Chapter 13, which establishes a five year repayment plan.

There are no prov

dd to the challenges in developing combination products:

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

isions in the law for debt problems caused by job loss, illness or other traumatic events, despite studies that show that these are the cause

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

of most bankruptcy cases.

Attorneys will now be responsible for the accuracy of paperwork filed by their clients. This will probab

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

ly result in fewer bankruptcy attorneys, with those that continue to practice raising their fees substantially in order to offset their addit

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

onal liability.

In short, most consumers are no longer protected from job loss or illness by being able to file under Chapter 7 and the

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

Professional from academic institutions, pharmaceutical industries, health care indust

y will have less help from competent attorneys due to the new liability provision of the bill. There is little to “protect” consumers in the

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

Bankruptcy Abuse and Consumer Protection Act. The sole benefit for consumers resulting from this bill will be lower interest rates and fees

.

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

from the credit card companies, who will save billions of dollars as a result of this legislation. Of course, should the credit card compani

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

Companies that provide selfless information through particip

s choose to keep the savings, rather than pass them on to their customers, then consumers will be left with no benefit or “protection” at all

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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