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Working with consumers often provides me with the opportunity to hear from a fairly good mix of people with different financial circumstances and with different goals. I conduct several free consultations throughout any given da

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

y and some of the most recent ones provided the inspiration for the theme of this edition of Debt Bytes.

I spoke with a woman earlier this week whose call I was returning days after her request for information due to

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

Examples of combination products may in

he fact that I was out of town (which is also why this publication is a few days late). She said thanks for the return call but that she had talked with a CCCS (Consumer Credit Counseling Services) and that she had made a decisi

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

n to work with them. I said that’s fine, but the call was free so if she wanted to discuss some of her challenges and goals, that I was available.

Her goal, ultimately, is home ownership. Her credit scores, however, w

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

re too low to qualify for most sub prime loan packages. She had some collection accounts that were 2 years and, in some cases, six years old. The CCCS program indicated that she would start giving them money each month that they

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

Combination pro

would then break the money down into smaller amounts and forward off to each collection account. Over time, she will have paid off these debts. This is, typically, the approach a CCCS program takes.

Here are the issu

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

s that I covered with her. In her state, the Statute of Limitation that applies to most of the defaulted accounts is 4 years. This means that her creditors or the collectors would only be able to sue her as a method of collect

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

ons for up to 4 years from the date of default. So, the accounts that are 6 years in default can no longer legitimately use the courts. Were she to start making payments through the CCCS program and suddenly find she is unable t

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

keep up with those payments, she would run the risk of the collectors having access to the courts for a newly established 4 year period. The oldest of these collection accounts that are reflecting poorly on her credit reports a

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

re due to start falling off her report in the next 12 to 18 months. Most negative items on your credit report can only be reported for 7 years (though the way this is interpreted can mean up to 7.5 years). So, starting a year fr

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

m now her credit report is going to start looking better.

Some of the more recent defaulted accounts have not gotten a payment form her in 2 years. A CCCS company generally will try to get interest reduced and penalti

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

Following aspects would a

s waived when they can and then start making small monthly payments. They don’t, at least to my knowledge, attempt to negotiate a settlement for less than the balance owed. Overall, the length of time you are enrolled in CCCS pr

dd to the challenges in developing combination products:

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

grams is dictated by the amount of overall debt and how much you are able to pay down each month. Some payments are so low that you really could end up just treading water with certain accounts. Meaning, you are paying almost no

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

thing to principle balance.

While you are enrolled in the CCCS program, it is usually noted on the credit bureau reports. Lenders generally look at CCCS enrollment the same they would a bankruptcy.

So, for

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

n undetermined amount of time she would be paying down debt while greatly reducing her ability to accomplish her goal of home ownership.

I know that it would appear as though I am putting CCCS programs in a bad light

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

That’s because I am. The example I have given shows that she would be far better served by seeking an alternative method of reaching her goals. I am sure that CCCS serves a purpose for a small amount of people. Generally though

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

Professional from academic institutions, pharmaceutical industries, health care indust

CCCS serves the creditors.

The point of all this being; Know Your Options! Seek out answers to all of your questions and make comparisons of any given method. Don’t throw money at something until you know that it wil

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

l provide the highest percentage of success towards achieving your goals. Talk to several people and read up on your issues. Don’t get sucked into a sales pitch. And, my personal opinion, don’t pay upfront fees for a program or

.

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

ervice that says they are going to get you out of debt (bankruptcy as a last alternative being an exception).

CRN would like to hear feedback from those of you that read the ‘debt bytes’ articles. Please feel free to

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

Companies that provide selfless information through particip

mail us at; info@consumerrecoverynetwork.com . Tell us about your experiences with debt and credit issues. As always, we are available to consult with you and assist you in exploring options to handle any of your debt challenges

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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The British insolvency code is under attack from small to medium sized business owners. There are elements of the code that said owners find quite biased. Here, in a nutshell, we will expose a few of the issues to stimulate further research.

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