Useful Advices - Business

Occupational Fraud: The use of one’s occupation for personal enrichment through the deliberate misuse or misapplication of the employing o

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

rganization’s resources or assets. -The key to occupational fraud is that the activity:
a. Is clandestine
b. Violates the employee’s fiduciary

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

Examples of combination products may in

duties to the organization
c. Is committed for the purpose of direct or indirect financial benefit to the employee

1. Employee Embezzleme

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

nt
-Most common type of occupational fraud (more than 80% of frauds)
-Employees deceive their employer by taking company assets.
-

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

Cash most targeted asset, taken 90% of the time

Occupational Fraud can be either direct or indirect
-Direct Fraud: employee steals company cash,

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

Combination pro

inventory, tools, supplies, or other assets, or establishes dummy companies and have employers pay for goods that are not actually delivered Does not use a

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

3rd party, the money goes straight to perpetrator’s pockets.

-Indirect Fraud: employees take bribes or kickbacks from vendors, customers, or others o

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

utside the company to allow for lower sales prices, higher purchase prices, nondelivery of goods, or the delivery of inferior goods. Usually payment to emp

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

loyees is made by organizations that deal with the perpetrator’s employer, not the employer itself.

2. Management Fraud
-Usually

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

fraud by top management’s deceptive manipulation of financial statements

3. Investment Fraud
-Closely related to management fra

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

ud
-Fraudulent and usually worthless investments are sold to unsuspecting investors.
-Charles Ponzi is father of investment scams
-In 2000,

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

Following aspects would a

more than $5 billion lost from telemarketing fraud
-Recent mutual fund frauds were investment scams using market timing and late trading
-Illega

dd to the challenges in developing combination products:

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

l market timing is an investment technique that involves short term in-and-out trading of mutual fund shares. This technique has caused losses to long term

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

mutual fund investors of approximately $5 billion per year.
-Late trading allowed selected investors to purchase mutual funds after 4 pm using that

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

days Net Asset Value (NAV) rather than the next day’s NAV that is required under law. Investors would capitalize on positive earnings news and then were al

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

lowed to immediately reap the benefit of the stocks upward movement the following day.

4. Vendor Fraud - 2 types
a. Fraud perpe

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

Professional from academic institutions, pharmaceutical industries, health care indust

trated by vendors acting alone
b. Fraud perpetrated through collusion between buyers and vendors
Usually results in either overcharge for purchas

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

ed goods, shipment of inferior goods, or nonshipment of goods even though payment is made

5. Customer Fraud
-Customers either do

.

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

not pay full price for goods purchased, they get something for nothing, or they deceive organizations into giving them something they should not have.

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

Companies that provide selfless information through particip

trong>6. Miscellaneous Fraud
-Fraud that doesn’t fit into first five types and may have been committed for reasons other than financial gain

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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