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The best way to find a tax preparer is a referral. The personality fit is very important. You are looking for someone you can talk to about money. That is a touchy subject and needs a high

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

comfort level. You need to look for basic competence; your preparer should know the easy stuff without looking it up. Beyond basic questions consider asking about some of the following is

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

Examples of combination products may in

ues.

Not only should you ask how many tax returns an accountant does but also “what kind?” If you are a schedule C taxpayer you need a preparer who does a lot of schedule “Cs”. Don’t let

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

hem off the hook when they give you a general answer like, “Oh, we do a lot of them” their tax software keeps track of such things and they should know an exact number.

The next critical

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

uestion is “who does the work?” If the tax preparer you are talking to delegates all the work to some kid in the back room fresh out of school, the $175 per hour fee is not justified. Ther

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

Combination pro

are some firms who are even subcontracting out tax preparation to India. You also might note US laws on confidentially are not enforceable in India.

Generally a good tax person should be

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

able to suggest something to you. There has to be something about your financial situation related to taxes deemed worthy of their comment.

At the other end of the spectrum be very wary 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

f the tax preparer makes many suggestions and also sells things. Like refund anticipation loans, brokerage, insurance or other financial investments. This is a conflict of interest and it

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

aints their advice. You want them on your side fighting the IRS not thinking about how to make commissions out of your pocket.

Find out if they handle multiple states. If you are nearing

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

etirement and moving to Arizona do they have the capability to do the home state and the new retirement state? A permanent move normally requires a change of tax preparer. State laws have

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

ittle quirks; the local guys are up to speed on. An out of state preparer either takes a lot of time to come up with the answers or misses the little stuff.

Ask how the fee is determined.

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

Following aspects would a

Some do it by the hour some by the schedule. Ask for an estimate. If it is based on a per form fee schedule ask for a copy of the fee schedule. Look at your last year’s tax return and dete

dd to the challenges in developing combination products:

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

mine what it would have cost based on their fee schedule. The prior year’s tax preparation fee is usually listed under miscellaneous itemized deductions. Tax preparers, who are asked for a

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

estimate, will ask to look at the form and casually glance at what you paid in the prior year. Few will charge less. Ask for their fee schedule and do the calculation yourself. Then ask i

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

f that sounds about right.

Lastly you might ask what happens if you get into an audit. The chances are remote but it does happen. Some firms offer, “audit insurance”. This “audit insuranc

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

” is normally not a good economic deal for the taxpayer. Just ask how many audits they have had on taxpayers in the last three years. Again do not be put off by a general answer. They know

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

Professional from academic institutions, pharmaceutical industries, health care indust

the number, there are not that many of them.

Don’t confuse a notice with an audit. If you do get a notice, and they are common, audits are not, what happens? Will the tax preparer answer

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

he notice as part of preparing the tax return?

Tax accountants are a straight-laced bunch. If they have been around for a while they have seen a lot of the problems including the ones sim

.

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

lar to yours. They can be a very valuable source of expertise. Just make sure they are on your side and have no conflicting loyalties.

One final thought, when you find someone you are hap

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

Companies that provide selfless information through particip

y with stick with him or her. Their value grows the more years you deal with them. They come to understand your situation, goals and problems and over time they can give you helpful advice

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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