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The Bankruptcy Abuse and Consumer Protection Act was passed in early 2005 with the overwhelming support of the President, both houses of Congress

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

and the major credit card companies. The law, which created sweeping changes in American bankruptcy law, was passed in order to reduce the poss

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

Examples of combination products may in

bility that consumers with heavy debts might avoid choose to avoid paying them by seeking debt relief through the courts. The Act has many provi

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

sions, but the one that may hurt consumers the most was the one provision that was intended to help – the requirement that debtors undergo mandat

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

ry credit counseling before filing for bankruptcy.

On the surface, the requirement seems to be laudable. Few people ever receive any sort of fo

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

Combination pro

mal money management training, so a bit of counseling, even as bankruptcy approaches, might help debtors avoid further financial trouble in the f

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

uture. The law was passed with the intention that, once educated, consumers would stay out of bankruptcy court in the years to come.

It hasn't

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

orked out that way, and the bankruptcy law is largely to blame. The law did not set a fee for this required credit counseling, but a fee of $50

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

as suggested and consumers who cannot afford to pay the fee may ask to have it waived. Only certain nonprofit counseling agencies would be appro

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

ved for pre-bankruptcy counseling. These requirements have resulted in a mess in the counseling industry that benefits virtually no one. Relati

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

ely few agencies have been approved; the ones that have are very busy. The suggested fee of $50, when paid at all, is not enough to cover the co

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

Following aspects would a

ts of keeping the agencies' offices open. Consumers are ending up getting their "counseling" via the Internet, or a conference call, or in a la

dd to the challenges in developing combination products:

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

rge group meeting. This sort of thing may satisfy the requirements of the law, but it isn't helping the people it was intended to help.

Credit

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

ounseling is certainly a worthwhile endeavor, but only if done properly. The counselor and the client should have sufficient time to become acqu

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

inted, discuss an overview of the counseling process and to have an in-depth discussion of the client's specific financial situation. After all,

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

if the client cannot receive information that he or she can apply directly to his or her own finances, the entire point of providing the service

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

Professional from academic institutions, pharmaceutical industries, health care indust

becomes rather moot.

Instead, we have a situation where the clients are being poorly served and the counseling agencies are barely scraping by f

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

nancially. It seems unlikely that this is what Congress had in mind when they passed the bill. Anyone who has a problem with debt would certain

.

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

ly benefit from counseling and is encouraged to seek it out. Those who do would be advised to select a counseling agency that has the time and r

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

Companies that provide selfless information through particip

sources to provide the in-depth sort of help from which a client can actually benefit. Otherwise, the result is a waste of time for all involved

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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