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In a study released in October, 2006 by the National Foundation for Credit Counseling (NFCC) on the e

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

ve of the one year anniversary of the 2005 Bankruptcy Reform legislation, there were a number of unan

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

Examples of combination products may in

ticipated results of the now mandatory pre-bankruptcy credit counseling.

The Bankruptcy Abuse Pr

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

vention and Consumer Protection Act of 2005 requires all debtors to get mandatory credit

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

counseling before they are permitted to file a chapter 7 or chapter 13 bankruptcy
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
trong>.

One of the most surprising results of the study are that consumers filing for bankruptcy hav
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
e a huge amount of debt, with average unsecured debt being almost $12,000 greater than their average
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
annual income, and this ratio is getting progressively worse. In addition, consumers filing for bankr
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ptcy protection are more likely to have mortgage delinquency problems, than those debtors who receive
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
d non-bankruptcy related credit counseling.

Although phone and internet based counseling are the mos
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
common type of service delivery, as opposed to in person counseling, the time required to complete p
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
re-discharge education sessions is taking more than 25% more time than aniticipated. These higher tha
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
n anticipated costs mean that the cost of providing services exceeded the fee income collected by NFC
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
agencies. The study states that "Based on current estimates of 600,000 bankruptcy filings in 2006 an
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d assuming the same delivery mix, an annual funding shortfall of $7.52 million appears likely for pre
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
filing counseling services delivered by NFCC agencies."

NFCC agencies waived the fee for services p
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
rovided for all consumers unable to pay for them, meaning that 16 percent of pre-filing sessions and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
13 percent of consumers attending pre- discharge education classes were provided free of charge. The
.

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
ig worry here is that if the costs of providing mandatory credit counseling becomes excessive, the en
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
tire credit counseling system may become difficult to continue, so stay tuned for further information

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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