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Under the section 404 of the Sarbanes-Oxley (SOX) Act, a public company has to file an internal report about the financial reporting procedures i

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

t follows, the effectiveness of its design and operation, and the trustworthiness of its financial dealings.

The Impact of Sarbanes Oxley on Pub

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

Examples of combination products may in

lic Companies: The internal report to be submitted under the SOX guidelines need to be detailed, and give a description of the financial dealing

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

and state of the company. The company needs to implement cost effective solutions, reduce wasteful expenditure and use effective measures to cut

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

down on costs. This is the only way to make a favorable impression once the internal report is out.

Sarbanes Oxley Compliance Act Risk Based Ap

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

Combination pro

roach According to financial gurus, the Sarbanes Oxley Act should be considered an opportunity for streamlining financial applications, and redu

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

cing costs for compliance. It is an opportunity for upgrading financial systems, and putting in modern infrastructure. Here are some risk-based 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

proaches:

1) Good Management: If the senior management is convinced about the advantages of controls, the employees and junior level managers a

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

lso come round to the idea. While the money and time spent on compliance may reduce after a period, the commitment of the management should never

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

diminish. In order to ensure compliance, incentives like promotions, raise, shares etc. are a good option. Those employees with good compliance r

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

ecords should be rewarded for the effort they put in.

2) Reviewing Controls: Test to see if the controls work, as they are intended to. Your ap

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

Following aspects would a

proach should be well planned. This will help reduce the number of controls you need to test by weeding out the ones that do not work. The risk-b

dd to the challenges in developing combination products:

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

sed approach is applied to controls for financial statements. You can also consider more than one type of control, or a blend of all, like manual

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

/automated, higher/lower etc.

3) Improving the Testing Procedure: Once the controls best for particular applications are singled out, it will b

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

necessary to test them for compliance. Since testing can be expensive, most companies stagger the procedure over a period of two years. In the s

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

econd year, more risk-based approaches are employed, and even external auditors called in, if needed. Internal testing procedures must be streaml

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

Professional from academic institutions, pharmaceutical industries, health care indust

ned, and testing plans are standardized.

Compliance with the Sarbanes Oxley Act makes it mandatory that organizations make testing procedures an

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

d the risk based approach part of their daily business applications. The Act should be seen as an opportunity for streamlining controls, reduce c

.

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

mplexity, improve communication within the organization, and reduce the risk of dishonest financial statements.

There are a number of consultant

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

Companies that provide selfless information through particip

s available who can help you and your company to prepare for Sarbanes Oxley Act. You can locate them all over the net by doing the correct search

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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