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The Problem

At one of the accounting forums I visit, quickbooksgroup.com, somebody wrote to explain

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

a problem she was having in her QuickBooks file. After some posts back and forth with her, I saw that it b

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

Examples of combination products may in

iled down to some changes her accountant made to the file - procedural changes which seemed unnecessary to

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, and which happened without the file owner's permission or understanding. I told her:

"Send the file

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

ack [to your accountant] and explain that her changes don't work for your way of doing things. Tell her to

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

Combination pro

put things back the way you had them. Also tell her not to change your procedures without first explaining

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

he new way she wants it, and also getting your permission for the change. Am I being unreasonable? Aren't y

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

u the one paying her bill?"

I understand that sometimes a change needs to be made in a QuickBooks file

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

I also understand that sometimes a change does not need to be made. Sometimes it's simply a preference iss

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

ue - this means that one person likes it one way, one person likes it another way. Neither is

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

wrong.

Who's File Is It, Anyway?

It seems that sometimes we, as accountants and bookkeepers, forge

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

Following aspects would a

who owns the file. Clearly, the person who posted the question was just as unclear as her accountant. Had

dd to the challenges in developing combination products:

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

he been clear that it was her file, not the accountant's, she would have known what to do without asking.

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

My Advice for Bookkeepers and Accountants Supporting QuickBooks

Be careful about implementing chang

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

s - people often have habits developed, and it's tough to change them. Don't do it unless it's absolutely n

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

cessary, make sure you get their consent, and train them thoroughly so they understand the new procedure.

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

Professional from academic institutions, pharmaceutical industries, health care indust

b>What To Do If Your File Has Been Changed

Don't be intimitated - even though your accountant knows mo

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

re about accounting, it's your file. Regardless if the change was necessary, you have a right to know about

.

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

it before it happens. Be straightforward with your accountant, and explain that you must give permission be

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

Companies that provide selfless information through particip

ore a procedural change is made. Also, if you don't understand the new procedure, insist on proper training

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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