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1st it was Sarbanes Oxly --- The Sarbanes-Oxley Act of 2002 commonly called SOX or Sarbox; is a United States federal law passed in response to a number of major corporate and accounting scandals including t

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

hose affecting Enron, Tyco International, and WorldCom. The legislation is wide ranging and establishes new or enhanced standards for all U.S. public company boards, management, and public accounting firms.

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

Examples of combination products may in

ome believe the legislation was necessary and useful, others believe it does more economic damage than it prevents, and yet others observe how essentially modest the Act is compared to the heavy rhetoric acc

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

mpanying it. At any rate even privately held companies are paying much closer attention to their accounting systems as a result.

Now Government wants to eliminate LIFO. LIFO stands for Last In, First Out. I

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

is an inventory costing methodology. The last in, first out, or LIFO method, selects the most recent purchases whose quantities add up to the total number of items sold during the year. The last in, or mos

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

Combination pro

recent purchases, are the first charged out to expense. The primary theory of the LIFO method is that products sold have to be replaced to continue in business and that the most recent (i.e., the last in) c

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

sts are the closest to the costs of replacing the products sold. From a tax standpoint, LIFO minimizes tax consequences by using the highest cost of inventory which reduces reported profit.

Congress is toy

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

ng with the idea that the elimination of LIFO can put billions of dollars into the Tax coffers. If the elimination of LIFO becomes a reality we are in for a devastating impact on our industry. In distributio

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

most of the profit is made on the buy side of the equation and the ability to manage inventory. For many of you, inventory management is your key core competence.

Can This Be Real

Official statements made

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

by Congress indicate that the issue of eliminating LIFO is no longer part of anyone’s agenda. The question becomes, “Can we believe that?” Congress authorized the use of LIFO in 1930. Can you imagine the num

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

er of companies that have adopted the LIFO system since 1930? Can you imagine the LIFO reserve that is built up just in our industry? (LIFO reserve is the difference between actual inventory cost based on FI

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

Following aspects would a

O (First In First Out) and the LIFO cost.

Currently these reserves are merely an accounting transaction. That means they are identified but they do not impact current reported profits. However, if the LIFO

dd to the challenges in developing combination products:

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

ystem was eliminated these reserves could become taxable as profit. This could be a significant tax liability for most companies that have adopted LIFO. Many of these companies may not be able to pay these t

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

xes and it could threaten their very existence.

Estimates of the tax revenue the elimination of the LIFO system could produce have exceeded twenty billion dollars according to a Senate committee. That estim

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

te included only publicly traded companies. Imagine what the number could be if it included the vast majority of privately held companies in the United States.

Fortunately this issue never got off the groun

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

. The President threatened to veto it. However, discussions continue to take place even though they may be outside the realm of real meetings and official agendas. It’s scary. Just the thought of government

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

Professional from academic institutions, pharmaceutical industries, health care indust

iscussing this issue is alarming in my opinion. Remember it can mean billions of dollars and money talks. This country has always had a propensity to spend. It seems to be part of our heritage and we live a

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

remendous life style in this country because of it. (At least in part) However, this country thrives because business and free enterprise is our platform – our foundation. It just scares me when we start tal

.

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

ing about messing with any part of that foundation.

Eliminating LIFO would be especially harmful to older industries that have adopted LIFO in the earliest years of its existence. So, keep your ears to the

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

Companies that provide selfless information through particip

ground and pay attention to what is going on in Congress. LIFO has become a business life style for many companies. We can not afford to eliminate it now. It can’t possibly do anything but damage our economy

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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A shocking 80% of Americans all have something in common. Can you guess what that is? They hate their jobs!

Negotiating with your boss can be a little tricky because you are not on equal footing. Since there is always the chance there could be repercussions for speaking out, an employee usually won't tell his boss what he is really thinking. Anyway, let’s assume that you want to get a raise or a promotion. Here are some of the rules you can use to negotiate with your boss.

The term conference can be used to describe any meeting of people to 'confer' on a certain topic. Far removed from the stereotypical 'year-end company conference' which is just an excuse for the whole company to pull into a posh hotel and have a weekend long party, the planning and execution of a successful and effective conference takes a lot of time, discipline and commitment.

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