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Over the last 5 years, the topic of “Debt Management” has continued to include more and more types of debt. From consumer credi

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

t card debt to debt consolidation and refinancing. Each of these topics can be quite complex and this article will not attempt

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

Examples of combination products may in

to cover each in depth. What you will find here is a summary on the basics of debt management how to find further detailed info

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

rmation. (It must be noted that credit repair is a completely different subject and warrants that you pursue credit related res

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

urces).

So, what exactly is debt management and what are the basics that everyone should be aware of?

First, before we get sta

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

Combination pro

rted, it is important to note that debt management is different than bankruptcy (Chapter 13). Bankruptcy is reserved for situat

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

ions in which a person is absolutely unable to re-pay their debt. People that have accumulated some debt but have a reasonable

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

chance of repaying it should strongly favor debt management. In addition, the bankruptcy laws have changed in 2006 making it le

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

s desirable in certain situations. Comparing the two alternatives in detail is beyond the scope of this article. We strongly s

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

uggest you consult with an expert before making ANY kind of decision.

The foundation of any debt management effort is having a

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

plan. As simple as that may sound, compiling a debt management plan can be the single most important step a person can take. A

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

Following aspects would a

nd the best way to formulate a comprehensive plan is through the advice of a credit counseling agency.

Finding a good credit co

dd to the challenges in developing combination products:

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

nselor can help you in several ways. As already noted, they can help you formulate a debt management plan. In addition, they

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

can work with your creditors to help obtain more reasonable interest rates (on your debt) or extend the allowed time frame of re

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

-paying the debt. Remember, credit counselors work with creditors every day and they know what works and how to best get you on

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

a path of re-paying your debt.

There are two types of credit counseling agencies – “for-profit” and “non-profit” agencies. On

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

Professional from academic institutions, pharmaceutical industries, health care indust

type is not necessarily better than the other. The best way to find the right fit is to contact as many agencies as you can an

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

d explore your options. If you decide to go with a non-profit group, we suggest that you contact the National Foundation Consum

.

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

er Credit (NFCC) to inquire if the agency is actually registered as non-profit. They can be reached at 1-800-388-2227. Also no

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

Companies that provide selfless information through particip

te, that a non-profit agency may still charge you nominal fees.

For more debt management resources and information please visit

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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