Main Subject - Finance

Congress recently passed the Bankruptcy Abuse Prevention and Consumer Protection Act, designed to minimize frivolous bankruptcy filings

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 to require debtors to repay some of their debt. Once it takes effect in October, 2005, the law will make it harder for those with p

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

Examples of combination products may in

oblem debt to have their debt wiped away by the courts. Most will have to agree to a five-year repayment plan. In passing this new law,

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

members of Congress suggested that our bankruptcy courts are filled with cases involving not ordinary citizens, but with reckless gamble

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

s, shoppers, and drug abusers. Is that really the case?

One would think, given the accusations, that the highest bankruptcy rate in th

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

Combination pro

Untied States would be in place where such vices were common, such as California, New York or even Nevada. If problem gambling is thou

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

ght to be the cause of so much bankruptcy, then one might assume that Las Vegas would be the bankruptcy capital of the world. How odd i

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

is, then, to discover that Utah, one of only two states that prohibits gambling completely, has the highest per capita incidence of ban

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

ruptcy filings in the United States. Utah? How can that be?

Utah has a number of aspects that, taken on their own, don’t suggest that

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

bankruptcy would be a problem. Added together, however, these things create a recipe for disaster:

Utah has the nation’s highest bir

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

hrate. Seventy percent of the citizens of Utah are members of the Church of Jesus Christ of Latter-Day Saints, and members are encourag

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

Following aspects would a

ed to have large families. It costs more to feed, clothe and house a large family than a small one.

Utah has more families wi

dd to the challenges in developing combination products:

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

h only one wager earner. Large families mean more stay-at-home moms, so a lot of families must get by on a single paycheck.

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

ah’s wages are lower than average. Many high tech companies have relocated to Utah in recent years, but the “high tech” jobs they provi

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

e are often telephone customer service jobs, which typically pay $8-10 per hour.

Members of the LDS Church are expected to tit

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

e 10% of their income to the Church.

While Utah’s home prices are not among the highest nationally, they are fairly high when

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

Professional from academic institutions, pharmaceutical industries, health care indust

compared to the average wage within the state.

The combination of large families, fewer workers per family, church donations and l

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

w wages have contributed to an economic environment that makes it very hard for many Utahns to stay afloat financially. This is in dire

.

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

t contrast with the arguments put forth by Congress when the new bankruptcy law was proposed, which suggested that most people filing fo

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

Companies that provide selfless information through particip

bankruptcy are simply irresponsible. For many hard-working people in Utah, the new law will make it harder than ever to make ends meet

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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