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By this time in 2007 it should be clear to just about everyone that identity theft is a real and growing problem throughout the world, but especially here in the United States where there is so much affluence (and of c

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

ourse available credit). The Federal Trade Commission reports that for the 5th year in a row identity theft topped the list of consumer complaints. In this article we will explore what identity theft is, how it is most

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

Examples of combination products may in

commonly perpetrated, and how big of a threat it really is to the average consumer.

Credit Card Fraud versus Identity Theft
When someone illegally obtains your credit card information and uses it

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

hen that is credit card fraud. It is not identity theft in the purest sense but when the government estimates the number of identity theft victims and the financial impact of identity theft it generally includes this nu

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

ber. The term most commonly used now is Identity Fraud which broadens the scope to include credit card fraud. In 2006 the total estimated cost of identity fraud was $56.6 billion, up from $54.4 billion in 2005. Credit c

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

Combination pro

rd fraud accounts for approximately 26% of identity theft. The balance of identity theft is comprised mostly of new account identity theft, where your personal information is compromised to the point where the thief is

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

ble to establish new accounts (bank, credit card, utilities) in your name. This type of theft can have a devastating effect on an individual's life and can take years and thousands of dollars to clean up and restore yo

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

r good name. Some individuals never recover from this type of identity theft.

Identity Theft Thieves
Most people think of identity theft thieves as individuals or small groups working together, di

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

ging through trash or stealing mail. While these are legitimate methods used by thieves, there is also a much broader identity theft market that get little media attention. And that is from computer data breaches. The

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

mount of personal information compromised from computer breaches in this country over the last two years is staggering. In 2005 there were 151 major data breaches potentially compromising the personal information of 57.

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

million individuals. In 2006 there were 327 data breaches totalling 48.8 million records. That's over 100 million records of various types of personal information floating around. As a result an entire black market ind

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

Following aspects would a

ustry has developed for these stolen records. This worldwide criminal identity theft marketplace is mature and is very structured. The players come from all over the world, but most of the Web sites where they meet are

dd to the challenges in developing combination products:

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

run from computer servers offshore or overseas, with many in the former Soviet Union, making them difficult to police. Credit cards, bank account numbers, Social Security numbers, and other personal data are commonly tr

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

ded and sold in huge numbers. There are buyers and sellers, intermediaries, service industries, and even tutorials.

The Next Big Threat?
And the assault is continuing. Gary Miliefsky, a founding

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

member of the U.S. Department of Homeland Security and chief technology officer of network security firm NetClarity, stated that Malware (an umbrella term used to a variety of hostile in intrusive program codes) attack

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

on personal computers are increasing at an unprecedented rate by organized criminals. "Malware writers are attacking your computer like they never have before," says Miliefsky. "Plain viruses are declining, and new at

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

Professional from academic institutions, pharmaceutical industries, health care indust

acks are taking advantage of a hole in an operating system or browser to plant Trojan viruses. As the business of online identity theft has continued to grow: malware is now an $8 billion industry, according to the FBI.

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

Preventing Identity Theft
Currently the average consumer has a 1 in 7 chance of becoming an identity theft victim. Identity theft thieves are attacking us on multiple fronts in their unrelenting q

.

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

est for our personal information. Our trash cans are being rifled through, our mail is being taken, corporate computers are being hacked and now even our own personal computers are under attack. The task of insuring the

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

Companies that provide selfless information through particip

safety of our personal information should not be taken lightly. A method of tracking and monitoring your credit is crucial to insure that no one can create a personal financial and credit disaster through identity theft

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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