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The Sarbanes-Oxley Act was passed on July 2002 and many public companies in the US have been implementing compliance procedures since then.

Unlike other business standards, the

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

Sarbanes-Oxley Act requires a more detailed disclosure in its filings with the US Securities and Exchange Commission (SEC) on everything that might affect a company’s business an

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

Examples of combination products may in

financial performance.

The Sarbanes-Oxley Act requires that public companies use well established "disclosure controls and procedures" for all intellectual property (IP) assets

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

so this vital information is first presented to the management of that company well before it’s revealed to the SEC. The Sarbanes-Oxley Act also requires these procedures to be e

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

aluated quarterly to ensure that outdated and ineffective procedures are removed and new ones implemented for better efficiency.

At the moment the Sarbanes Oxley Act does not ac

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

Combination pro

ually define the steps a public company should specifically take in order to ensure complete compliance with the Act. As a result most public companies are usually left in a bit

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

f a quandary.

A big hurdle for companies is to fully inventory their Intellectual Property Assets (IP assets). Intellectual Property rights in themselves are a quagmire of regul

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

tions and laws and since the Sarbanes-Oxley Act requires all IP assets to be help accountable to the SEC this usually causes a big problem. Going further, it is not often an easy

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

matter to determine exactly how the I.P. assets of a company are affecting its financial performance. This involves an internal audit and information gathering process of a compa

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

y and can prove to be time consuming and financially unviable until the procedure becomes well established and is a matter of routine.

The next step is to determine the value of

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

each IP asset and finding out exactly what the nature of this asset is with regard to the company's financial performance. Since Sarbanes-Oxley compliance requires a clear insigh

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

Following aspects would a

t into the financial workings of a public company this becomes a complicated issue. That’s because the value of an asset here is not simply monetary, yet using good Sarbanes Oxle

dd to the challenges in developing combination products:

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

software can help manage and audit this necessary procedure.

Since IP asset value is lost or gained based on the intellectual property rights obtained for any given product the

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

value of an IP asset it is easier to explain to the SEC how in compliance with Sarbanes Oxley the company has more or less valued that asset.

The management's next job, to ease

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

he ongoing implementation and compliance with the Sarbanes-Oxley Act, is to make sure that there are procedures in place that automatically protect their IP assets. To ensure o

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

going Sarbanes Oxley compliance it is essential to conduct employee training starting from the top and trickling downwards with reinforcement at every step of the way. It is impo

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

Professional from academic institutions, pharmaceutical industries, health care indust

tant that actions taken on these procedures and the reports generated are move upwards so that they can reach the appropriate division heads and ultimately the CEOs and board of

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

irectors.

Management will have to think of new ways and methods to make this happen because such broad and overall changes are not easy to implement when the established culture

.

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

is so contrary to what is now being expected.

Since the scandals of previous public companies have resulted in the enactment of the Sarbanes-Oxley Act, the Act demands a clearer

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

Companies that provide selfless information through particip

look into a public company's finances. This involves more honesty at each step, involving everything, that would affect a company's financial performance, for better or for worse

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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