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Preparing your tax return is a task similar to mating with an elephant. It takes a long time, there is a lot of yelling and y

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

ou usually have a headache by the end. All of this can lead to mistakes on your return.

Most taxpayers set out to tell the w

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

Examples of combination products may in

ole truth and nothing but the truth when filing their returns. By the time you have filled out your eight worksheet related 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.

line 27, subsection A of the 1040 form, you don’t know if you are a liar or a saint. It is all so confusing that it can brin

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

a person to their knees. Confusion and frustration, of course, lead to mistakes. Mistakes then lead to unwanted attention fr

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

Combination pro

m the IRS. Well, all attention from the IRS is unwanted, but you get my drift.

Ironically, it is mistakes with basic things

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

that get most people in trouble. The IRS looks for basic information from your tax return. When your return doesn’t match oth

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

r records, you have a problem. When it doesn’t make sense in and of itself, you also have trouble. Here are some of the basic

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

mistakes to watch out for.

1. Check Your Math – Did you carry the one? Are you sure the decimal is in the right place? The b

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

ggest error found with tax returns has to do with math errors. If you drove 1,000 miles on business, how could your tax deduc

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

ion be $4,450? You made a mistake somewhere. It should be $445. As painful as this may sound, you should sleep on a finished

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

Following aspects would a

tax return and recheck it the next morning to make sure the numbers are all accurate.

2. Married Filing Jointly – If you are

dd to the challenges in developing combination products:

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

filing under this status, you are effectively combining two tax returns in one. The IRS, of course, does not know this unless

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

you tell them. Make sure to enter your social security number AND the number for your spouse.

3. W-2s and 1099-MISC – If you

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

are a salaried employee, your employer should have issued you a W-2 form. Make sure to attach it to the tax return when you s

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

nd it off. If you received 1099-MISC forms as an independent contractor, do NOT attach the forms to your tax return. The pers

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

Professional from academic institutions, pharmaceutical industries, health care indust

on issuing the forms to you already sent them to the IRS.

Finally, a bit of practical advice. You are expected to report you

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

accurate earnings and there is no exception to this rule. Many independent contractors run afoul of the IRS in this regard.

.

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

hen they do not receive a 1099-MISC from a client they performed services for, they assume they don’t have to include the rev

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

Companies that provide selfless information through particip

nues on their tax return. Um, no. You must report all income regardless of what other people did or did not file with the IRS

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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