Main Subject - Business

Create & Maintain an Appropriate Culture

Culture is important in any organization but to have the appropriate attitude of honesty and high ethic

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

al standards is important to prevent fraud. Management must demonstrate this model by providing a tone at the top emphasis on this culture. After setting the ton

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

Examples of combination products may in

e, management must follow up on this commitment by hiring the right people for the job and ensuring that their hiring policies are effective at eliminating those p

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

eople that do not meet the standards set by the culture. The hiring process should entail some form of background check in order to gather some information about

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

their past ethical behavior. After acceptance of new employees, management should clearly communicate their expectations and require written confirmation of a mut

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

Combination pro

ual understanding of these expectations.

Methods of Establishing Ethical Corporate Culture

1. Code of Conduct - Should identify values and ethi

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

cs expectations of the company. They are most effective when supported by management and placed in sight of employees.
2. Training - On going updates throug

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

out a employees time helps reinforce managements demand for ethical behavior.
3. Consistent Punishment - Violators of Code of Conduct must be handled per the

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

expectations set and done so in a timely manner. It is necessary to enforce the rules to ensure that other employees see management as taking it very seriously.

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

Assessing the Risk of Fraud

Organizations can proactively eliminate opportunities to commit fraud by frequently assessing the risks and developi

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

ng mitigation plans. In order to assess the risk of fraud a company must understand and identify the source of their risks. By creating a process to identify the

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

Following aspects would a

most important risks they are able to design effective controls to mitigate the risk. Using internal controls will have a two fold effect of prevention and detec

dd to the challenges in developing combination products:

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

tion of fraud by having alert procedures in place.

One of the most effective internal controls can be your other employees. By creating a system of monitoring ot

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

hers work and segregation of duties, management is able to provide a means of preventing fraud while establishing a communication channel to report suspicious acti

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

ity. Sarbanes Oxley (SOX) has made this a requirement for public companies in that management must create a system to provide whistle blower protection for those

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

that communicate that fraud is going on. SOX also prohibits retaliation against employees who use the system to report questionable behavior. If the company viol

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

Professional from academic institutions, pharmaceutical industries, health care indust

ates these requirements it is subject to a lawsuit by the employee.

Lastly, the most important control that public companies must submit to is having an independe

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

nt audit by an accounting firm. Although these firms are unable to test all transactions made by the company, by using statistical sampling they are able to addre

.

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

ss which accounts have the most significant risks therefore they can require more testing of those accounts. These firms also test their company's' controls for m

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

Companies that provide selfless information through particip

aterial weaknesses. If a company is found to have a material weakness they must fix the controls or will be issued a qualified opinion of their financial position

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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Main Subject - Fraud Prevention - The Most Cost Effective Way to Reduce Losses

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