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“Oh My God”, cries out my fifteen year old daughter. “Oh My God Is Right”, replies her brilliant and handsome father. This is an example of two people saying the very same thin

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

g, but for entirely different reasons. I can’t help but wonder when I read other income tax and business articles if the writer has the same understanding of purpose that I hol

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

Examples of combination products may in

so very dear. When we go into business, the idea is to make money by fulfilling a dream. If we are not in pursuit of profit, we are not in pursuit of a dream, and we don’t hav

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

e deductions against taxable income. This my friends is how we play the game and I am about to explain what running a business is all about. Let me assure you that economic ben

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

fit is first, followed by the art of practicing income tax to enhance our return on investment.

Income tax deductions can be a beautiful thing. In order for a tax deduction to

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

Combination pro

be beneficial, there must be some income. Income is the spice of life and how we survive and thrive in a free market society. When we first think of starting a home-based busi

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

ess (or any business for that matter), we are in hopes of providing goods or services that folks are willing to buy. If and when we can master this very difficult task, we can

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

think of the joys of revenue enhancement as it relates to income tax savings through planning. When I think of the home office deduction, I am thinking of a profitable busines

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

that has thought long and hard in regards to its entity selection, its operations, and its plan for the future. I know that I can use expenses that would otherwise not have be

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

en deductible and use them to reduce not only income tax exposure, but will reduce exposure to payroll taxes as well (please check out my audio CD at www.mwibonline.com for the

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

full picture on the home office deduction). When others write of the home office deduction, it makes me wonder whether other issues have been taken into consideration. Should t

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

Following aspects would a

he business be organized as a sole proprietorship to take advantage of this home office deduction? Would it have been better to incorporate and rent office space from our perso

dd to the challenges in developing combination products:

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

al residence thus changing the way we record this transaction on our personal income tax returns? Does the person who has written the article have a good understanding of reven

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

ue procedure 2005-14, thus explaining how the sale of a principal residence, with business use of the property, is handled for income tax purposes? As an aside, the treatment o

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

selling a principal residence with business use in the property can be quite favorable (audio CD for Home Office Deductions at www.mwibonline.com).

I think it is important to

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

note here that the home office deduction is only of value when the business is profitable. In a year where the business is at a loss, the home office deduction is not currentl

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

Professional from academic institutions, pharmaceutical industries, health care indust

deductible but can be carried over for future use. Remember the hobby rules when starting a new business venture and be sure that the business is seeking a profit. The guideli

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

ne to follow is 3 out of 5 years should be profitable (2 out of 7 years for businesses involving the horse trade) to keep the burden of proof on IRS regarding whether or not on

.

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

is seeking a profit motive. If this test is not met, it doesn’t mean the jig is up, it just means that the burden switches to the taxpayer to determine profit motive. I just c

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

Companies that provide selfless information through particip

an’t help but wonder, when I say home office deduction, and some else says home office deduction, if we are actually both saying the same thing. “Oh My God”, I really do wonder

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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