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Well, its tax season again. That means millions of people will be rushing to file before the deadline and

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

just as many will be eagerly awaiting their return. Tax returns are a funny thing. People tend to treat

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

Examples of combination products may in

them differently than any other money. The rest of the year they will save, pinch pennies, and budget. Wh

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

en they get their tax return, they go wild.

In fact, I’ve seen people go so far as to make sure extra ta

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

xes are withheld throughout the year just so that they can have a large return! One person I talked to sa

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

Combination pro

d that they did this as part of their saving plan. This does not make good financial sense though. First

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

of all, as I mentioned, people tend to spend the money from their returns more freely. Second of all, you

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

are allowing the government use of your money throughout the year. You are not paid interest or anything

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

like that on your oversized return. Had you invested the extra money, or even just deposited it in your

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

savings account, you would have earned interest on it through the year. By paying too much in taxes throu

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

h the year, you are losing the chance to earn interest.

I’ve also heard people say that they want to mak

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

Following aspects would a

e sure that they don’t owe money at the end of the year. This is probably the most reasonable train of th

dd to the challenges in developing combination products:

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

ought, however, it still does not hold water. When you file your tax return, you are telling the governme

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

nt how much money they should have taxed you on. If you either forget about a deduction, or are not aware

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

of one, you will not get that extra money back. It would be financially smarter to pay less throughout t

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 year, and then establish what if any more you owe at the end of the tax year.

With the advent of the I

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

Professional from academic institutions, pharmaceutical industries, health care indust

nternet, taxes have taken on a whole new life. You are now able to file online, as well as use different

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

computer programs to help you calculate your return and even register to have your tax return deposited d

.

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

irectly into your bank account. This is a quicker way to both file, as well as receive your return. Howev

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

Companies that provide selfless information through particip

er, one should be careful not to wait too long to file just because of the instant nature of the Internet

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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