Answers - Legal

His hard earned money? Gone. Creditors on his back everyday. Police knocking on his door. His family strained to the breaking point. He didn't do anyth

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

ing wrong but my business partner's life got turned upside down a few years back. He became a victim of what is now the fastest growing crime in the wo

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

Examples of combination products may in

rld. Identity theft.

According to the Federal Trade Commission, since 1999 over 27 million people in the US alone became victims of this epidemic 10

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

million more last year. Harris InterActive,a marketing research company, reports that between 2002 and 2003 roughly 19,178 people per day fell victim

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

.

Your identity can be stolen in many ways. For my partner, the thief gained access to his social security number and address then applied for a ser

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

Combination pro

ies of loans in his name. When the bills came due, guess who the creditors and law enforcement held accountable?

He and his family felt the full impa

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

ct. Identity theft can cripple and even destroy a person's life. Not just the time loss trying to recover your identity but also the out of pocket e

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

xpense. U.S.Treasury Secretary John Snow calls identity theft "the greatest threat to consumers and far more insidious and harmful to our national we

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

lfare than many people realize."

The internet doesn't make it any better with its almost limitless access to information but a great deal of identit

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

y theft still comes from the offline world. Wherever it comes from the goal stays the same. Get your personnal information and steal what belongs to

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

you for as long as possible.

In many cases, this can lead to the victim filing for bankruptcy or worse. As reported by the Orlando Sentinel, one ma

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

Following aspects would a

n whose identity got stolen recently spent 54 days in jail before authorities realized their mistake.

Yet even when the thief finally gets caught, vi

dd to the challenges in developing combination products:

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

ctims find out all too often the worse part still lies ahead. The recovery of their identity. For my partner, that meant never ending battles with t

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

he same credit bureaus that previously gave him good ratings.

They destroyed his credit almost overnight eventhough he did everything they told him

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

to get it restored. The agencies refused to clear his record and instead, started sharing his information with each other. His mortgage rates went t

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

hru the roof. He paid more for everything but still got declined. With all of this came the burden and fear of him not knowing if he would ever recov

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

Professional from academic institutions, pharmaceutical industries, health care indust

er his identity.

Six years later he finally did. He started working with a company that within 90 days restored his credit. His mortgage rate droppe

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

d and he went back to paying full price for everything like the rest of us.

And like my partner, all of us risk becoming victims. In San Antonio Tex

.

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

as, television station KENS 5 spoke with a man convicted of identity theft who warned "Don't take for granted what you have because anybody could tak

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

Companies that provide selfless information through particip

e it away — I mean at the snap of a finger."

He would know. The ways of stealing an identity have turned this crime from nuisance to worldwide crisis

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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