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Sarbanes Oxley, also known as SOX or SarbOx, an act that came into force in July 2002, is considered as one of the most important changes in

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

United States securities laws. Approved by the U.S. House of Representatives and the Senate, the SOX brought major modifications to the rulin

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

Examples of combination products may in

g of corporate administration and financial practice. Passed to appraise all legislative audit requirements, the SarbOx offers extra powers a

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

nd duties to the U. S. Securities and Exchange Commission.

Sarbanes Oxley is named for Senator Paul Sarbanes and Representative Michael Oxle

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

y, who were the key architects of this law. It covers issues like auditor independence, corporate responsibility and sets up new or improved

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

Combination pro

principles for all U.S. public company boards and accounting firms. SOX is arranged into eleven ‘Titles’, including issues that range from co

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

rporate board responsibilities to criminal penalties. As far as compliance is concerned, the imperative sections among the eleven include 302

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

, 401, 404, 409, 802 and 906.

Section 302 is listed under Title III of SOX, the corporate responsibility for financial reports. This section

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

makes it essential for a set of internal actions to be planned to guarantee exact financial disclosure. The CEO or CFO is obliged to certify

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

that they are in charge for establishing and maintaining internal controls.

The 401 section under Title IV of SOX (enhanced financial discl

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

osures) is a part of 'Disclosures in Periodic Reports'. This states that the financial statements published by managements are required to be

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

Following aspects would a

accurate and presented in a way that does not involve any incorrect statement. All material off-balance sheet liabilities, obligations or tr

dd to the challenges in developing combination products:

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

ansactions are also included in these statements.

Section 404 (under Title IV) refers to 'Management Assessment of Internal Controls'. Issue

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

rs are required to produce an annual report regarding the scope and sufficiency of the internal control structure and procedures for financia

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

l reporting.

Under the section 409 which pertains to 'Real Time Issuer Disclosures', the business managements are required to disclose to th

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

e public, on urgent basis, information concerning material changes in their financial state or operations. Another point is that these disclo

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

Professional from academic institutions, pharmaceutical industries, health care indust

sures are easy to understand. Qualitative information of graphic presentations is a suitable option.

Section 802, 'criminal penalties for al

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

tering documents', impose severe penalties and/or up to 20 years imprisonment for changing, destructing, falsifying documents with the object

.

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

ive to block or influence a legal inquiry. Section 906, or "906 Certification", needs that all periodic reports that contain financial statem

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

Companies that provide selfless information through particip

ents filed with the SEC (the Security and Exchange Commission) are accompanied by a written declaration of the CEO and the CFO of the company

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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