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(The author of this article is not a tax attorney, CPA, or enrolled agent, and this is not to be considered tax advice. If you need tax advice, you should consult someone

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

who is certified in this arena.

Did you hear about Bill Gates? He decided to give away all his shares of Microsoft and start working at a car wash in Seattle. Wh

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

Examples of combination products may in

en Larry King asked him why he decided to do it, Gates admitted that he was losing too much money on the taxes. You see---by making $7 an hour, he would be in the lowest t

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

ax bracket, and if he could manage to make less than $19,000 a year, then he would not have to pay any taxes at all! Back when he was making a $1 billion annually, he was

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

left with $500 million after taxes every year. So Gates thinks he can make more money this way.

As preposterous as the above example sounds, it’s exactly the sa

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

Combination pro

me logic employed by consumers who fear the tax implications of debt settlement. For one, most people enrolled in debt negotiation programs don’t have to pay taxes on thei

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

r savings as is (more on this later). Secondly, why in the world would it ever even deter you from enrolling in a debt settlement program anyway? It’s literally the equiv

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

lent of someone turning down a million dollar salary for minimum wages because of the favorable tax implications. Consider the following scenario.br>

Frank owed $20,0

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

00 at 19% interest when he enrolled in a debt settlement program. When it was all said and done, Frank was able to reduce his debt down by 45% and in the process he saved

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

$9000 off the balance alone. Unfortunately, each of his creditors reported his savings to the IRS and he was forced to tack on $9000 to his $40,000 annual income. So he w

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

as taxed like he made $49,000, which put him in the 30% tax bracket and meant he had to come up with $2700 on April 15th. Regrettably, Frank did not have the money, so he

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

Following aspects would a

got on a payment plan with the IRS, who charged him their current interest rate, which happens to be 8 percent annually. In the end, Frank paid off the IRS in 1 year for $

dd to the challenges in developing combination products:

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

2916. This means that Frank in actuality only saved about $6,000 off the balance. So would Frank have been better off continuing to pay the minimums instead of settling h

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

is debts? Let’s see. He saved $6,000 off the balance alone and roughly $40,000 in interest charges, which brings his net savings to $46,000. It’s pretty clear that it wa

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

still in Frank’s best interests financially to do debt settlement.

It does not end here. Most debt settlement candidates never have to pay taxes on the debt anyw

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

ay. The IRS exempts anyone who was technically insolvent at the time their debt was settled from having to pay taxes on the savings. So the next question is, what does it

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

Professional from academic institutions, pharmaceutical industries, health care indust

mean to be insolvent? According the IRS, someone is insolvent when their assets (what you own) exceed their liabilities (what you owe), and it should come as no surprise

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

that when someone is at the point when they’re seeking debt relief, they’re probably in debt up to their eye balls and therefore are insolvent. If you owe more than the va

.

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

lue of your assets, then all you have to do is fill out IRS form 982 along with your tax return illustrating this fact. All told it will probably take you a couple hours t

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

Companies that provide selfless information through particip

o do this, and if you saved $46,000 like Frank in our example, then it’s the equivalent of making $23,000 an hour. Unless you’re Bill Gates, it’s probably worth it.

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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