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Eight becomes Six, Six becomes Five, Five becomes Four, Four becomes Three? Well, for those of you who are not well versed with the top four Accounting firms, this would sound

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

like a Montessori school lesson.

Big4.com-a website catering to Big4 alumni- receives periodic updates on the latest news and trends at the Big Four accounting firms. The pr

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

Examples of combination products may in

sent Big 4 firms were all a part of the previous Big 8. The Big 8 term reflected the extensive dominance of the eight largest accounting firms in the world. Mergers of regiona

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

l accounting firms led to the birth of Big Eight.

The Big Eight companies were-
· Arthur Andersen
· Arthur Young
· Coopers Lybrand
· Ernst Ernst (later be

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

ame Ernst & Whitney)
· Haskins Sells (later became Deloitte, Haskins, Sells)
· Peat Marwick International (later became KPMG)
· Price Waterhouse
· Touche R

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

Combination pro

ss

In 1989, the Big Eight became Big Six when Ernst Whitney had a merger with Arthur Young to form Ernst Young. Deloitte, Haskins Sells merged with Coopers Lybrand to form Pr

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

icewaterhouse Coopers.

The Big 5 descended from Big Six. Big Five Firms were the world’s top five companies with disparate areas of specialization. They were-
· Arthur A

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

dersen
· Deloitte & Touche
· Ernst & Young
· KPMG
· PricewaterhouseCoopers

The collapse of Enron in 2001 caused Arthur Andersen to step out of the erstwhi

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

le "Big Five" Group. After the SEC (Securities and Exchange Commission) revealed off-balance sheet costs-undisclosed losses of hundreds of millions of dollars-Arthur Andersen

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

onsulting bowed out of the Big Five League.

Close on the heels of Arthur Andersen’s downfall, KPMG, the New York based accounting firm faces indictment charges for allegedly

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

elling Tax shelters. As the Justice Department considers the penalties for KPMG, things might go awry if the firm is convicted of obstruction of justice.

Reforms like Sarbane

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

Following aspects would a

s-Oxley have stressed the importance of complete audits to expose and mitigate fraudulent behavior. Now, the onus might, as well, shift on the three major auditing firms as KP

dd to the challenges in developing combination products:

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

G faces indictment charges. If guilty, KPMG would no longer be able to certify the audit results. Consequently, their customer base might shift to other accounting giants.

Ac

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

cording to many accounting experts, indicting KPMG or any other Big Four accounting firm would damage accounting relationships and eventually lead to loss of jobs. The absence

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

of KPMG would mean less competition, although firms might attract more business and clients. This destructive option can be replaced with a sensible alternative- indicting par

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

ners and other employees of firms who are found guilty. Supporting this ideology, KPMG have started the process of terminating employees connected with the tax-shelter scandal

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

Professional from academic institutions, pharmaceutical industries, health care indust

and envisaged policy changes to eradicate unethical business practices.

While it’s true that punitive action should be employed if and when unlawful business practices are f

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

llowed, it’s not necessary for KPMG to face the axe. If these giants are cut to size frequently, then people would have to run from pillar to post searching for efficient busi

.

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

ness partners. Reforms like Sarbanes-Oxley are the order of the day. Sarbanes-Oxley specifies that rotation of audit partners (on a periodic basis) regulates any congenial che

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

Companies that provide selfless information through particip

istry between executives and auditors. Implementing and following these policies would enable best practices in business environs and facilitate transparent auditing processes

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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