Others - Finance

Recently passed by Congress, the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 will require people who are filing for bankruptcy to first underg

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

o mandatory credit counseling.

This is probably not a bad idea; after all, many people with problem debt could probably benefit from credit counseling.

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

Examples of combination products may in

good credit counselor can assist clients with problem debts in establishing a repayment schedule, creating a personal budget, and learning how to avoid debt and

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

redit problems in the future.

The problem is that with the estimated one and a half million additional people seeking credit counseling each year, there

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

will undoubtedly be more credit "counselors" entering the market, and many of them are only interested in reaping huge profits at the expense of their clients. T

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

Combination pro

ere are already a number of credit counseling firms working in the marketplace that advertise themselves as "nonprofit", when they actually are closely tied to fo

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

-profit debt consolidation firms. These agencies will strongly encourage their clients to consolidate debt through their partner company, and the result may be a

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

long term loan for the client that doesn't help them at all, but reaps huge profits for the consolidation firm. How can someone who is genuinely seeking legitim

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

te, helpful credit counseling choose a counseling agency wisely?

*Counselors should listen. If they start pitching a solution to you during the first fi

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

teen minutes you are there, you should be suspicious. A credit counselor should be gathering information about you in order to determine how best to help you. T

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

ey can’t possibly know how to help if they don’t understand your problem. Unless, of course, they don’t care about your problem and only want to sell generic “so

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

Following aspects would a

lutions.”

*Watch out for firms that want excessive fees up front. Be particularly wary of nonprofit agencies that ask for fees or “voluntary contributio

dd to the challenges in developing combination products:

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

s” or nonprofit agencies that tell you that they cannot help you if you do not pay a fee upfront.
*Sometimes, bankruptcy is unavoidable. Watch out if the ag

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

ncy doesn’t mention bankruptcy at all, or if they change the subject if you bring up the topic. Debt consoldators cannot make any money on bankruptcy cases, but

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

sometimes, that’s your only option.

*Shop around. Talk to several different agencies and compare what they tell you. Any agency that differs dramatical

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

y from what the other agencies are telling you should probably be avoided.

*Check with your local Better Business Bureau, and ask if they’ve had any comp

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

Professional from academic institutions, pharmaceutical industries, health care indust

aints about the agency.

*Watch out for firms that offer quick solutions to your problems. You didn’t get into financial trouble overnight, and you won’t

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

get out of financial trouble overnight. Any competent debt or credit counselor will know this and will undoubtedly tell you that working your way out of debt ta

.

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

es time.

*See if the agency belongs to the National Foundation for Credit Counseling or Association of Independent Consumer Credit Counseling Agencies.

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

Companies that provide selfless information through particip

any do.

By taking a few simple precautions before agreeing to work with a credit counselor, you may save yourself a lot of grief and a lot of money later

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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