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Fraud Symptom Categories

1. Internal Control Problems - material weakness
The first thing to remember when looking at internal contro

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

ls is the fraud triangle. Without all three elements of opportunity, pressure and rationalization it is less likely that fraud will occur. By creating controls that preven

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

Examples of combination products may in

these elements or detect them in a timely manner after occurance managers can effectively monitor compliance.

Specific internal control issues stem from the organizations

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

structure. Examples of symptoms of control deficiencies include a lack of the following: segregation of duties, independent verification, proper authorization, physical saf

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

guards, overriding the system in place, and proper documentation.

2. Analytical Irregularities
These symptoms are unusual relationships of current fin

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

Combination pro

ncial statement ratios are compared to prior years. The analytical tests identify those transactions that are extreme cases and fall outside of the normal distribution of v

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

alues. Common examples include: shortages of inventory, the use of too many credits to accounts receivable, or the existence of new vendors.

3. Accounting Abnormal

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

ties
The symptoms of accounting issues involve problems with faulty journal entries, nonexistent or fraudulent source documents, and incorrect ledger balances.

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

Journal entries that are tampered with by smart fraudsters tend to be the expense accounts. In order to balance the accounting equation they must expense an amount equal

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

o what they stole. Source documents can have all sorts of problems because many times they are vendor invoices that can be manipulated by those with direct access. It is i

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

portant to retain all original copies and to verify with customers/vendors through the use of confirmations. Lastly, ledger problems come about when there is a mismatch of

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

Following aspects would a

ledger balances not equaling the master file or each individual ledger balance not reconciling. Either way it is a sign of an incomplete fraud scheme.

4. Extravaga

dd to the challenges in developing combination products:

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

t Lifestyle &/or Unusual Behavior
Lifestyle changes are often the easiest of all symptoms to detect. Although looking at bank records, investment records, and

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

tax return information are difficult to access; property records, UCC filings, and other records are easy to check to determine whether there are assets that have been purc

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

ased or liens that have been removed. Unusual behavior is seen through an individual's recognizable behavior pattern to attempt to cope with the stress. Their guilt leads

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

o fear, fear leads to stress, and stress leads to behavior changes.

5. Tips and Complaints
These are considered to be symptoms instead of evidence bec

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

Professional from academic institutions, pharmaceutical industries, health care indust

ause often times they turn out to be unjustified. Despite their failure they can be extremely helpful when those in the best position to detect fraud step forward.

-cowork

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

rs, managers, and other employees are usually in the best position to detect fraud in the theft act stage
-company accountants and even coworkers are probably in the be

.

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

st position to detect fraud in concealment
-coworkers, friends, and managers are also in a better position to detect fraud in conversion

Since this is the case, it is

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

Companies that provide selfless information through particip

mportant that companies maintain a whistleblower protection program or keep open a anonymous fraud hotline. Detection and communication offer the best protection from fraud

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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