Main Subject - Business

Last year a 15 member commission was created by the US Chamber of Commerce to evaluate 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

effects of litigation & regulation on the US capital market. Tom Donohue, the CEO of the C

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

Examples of combination products may in

hamber, is a powerful business lobbyist that has become critical of the implementation of S

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

arbanes Oxley (SarBox) especially section 404 which covers the assessment of internal contr

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

ols.

The question remains: Is the litigious US business environment drivi

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

Combination pro

g away foreign investment in US public companies? Has the SarBox section 404 caused these

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

declines and how could it be changed to build confidence but retain assurance of the effici

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

ency of internal controls?

Despite the criticisms in the report, the Securi

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

ties and Exchange Commission's (SEC) Christopher Cox has responded with an acknowledgement

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

of the difficulties of SarBox but an emphasis on the new changes. The Complete Act of 2007

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

recommends a limitation of section 404 that only requires the internal control audit on a t

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

Following aspects would a

hree year basis. Another change proposed attempts to reduce the costs of these 404 audits

dd to the challenges in developing combination products:

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

for smaller companies by making them voluntary. There is also a movement to rely more heav

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

ily on the internal audit function for an assessment of lower risk internal controls.

By c

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

hanging the rules for implementation the SEC feels that it would appropriately mitigate the

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

costs to firms for their audit AND reduce their exposure to unwarranted securities fraud la

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

Professional from academic institutions, pharmaceutical industries, health care indust

wsuits. This is important to keeping the confidence of foreign and domestic investors but

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

also to the public companies that must adhere to these strict regulations. It will continu

.

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

e to be a concern for foreign companies wanting to enter into the US capital market. The S

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

Companies that provide selfless information through particip

EC's ultimate response will have a significant impact on the future of US public investment

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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