Advice Pool - Legal

My dad always says that “it takes all kinds of people to make up the world”, but looking at the ever-increasing reports of identity theft, you have to wonder if that is really necessary. Identity theft is one of the fastest growing crimes today, and if

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

you don’t take precautions, you could be the next victim. The funny thing is, if you think about it, the precautions you should take are all common sense!

How does it work? Very simply, someone gets some information about you, perhaps online or perhap

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

Examples of combination products may in

even via some junk mail that you tossed in the trash without even tearing it up. It has your name, address, date of birth, and social security number. So armed with that information, someone opens a Visa account at a bank with YOUR information, except

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

that they put THEIR address on the application form. What’s wrong with that, people move all the time, so they indicate this is a new address and also enter your old address. Based on the name, old address, social security number, it is determined tha

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

you have good credit, so the card is issued and sent to the NEW address, where the thief then starts a spending spree.

The problem comes in because it will be at least 30 days before the Visa company knows there is a problem there. That is 30 days of

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

Combination pro

pending and charging that Visa card up to its limit. The bill is sent 30 days later, it is of course ignored, and then they start trying to call you. When the REAL YOU is finally reached, now there is a problem because someone via identity theft used Y

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

OUR information to charge up a truckload of stuff and now they cannot be found.

Interestingly enough, the majority of the credit card companies are skeptical and very suspicious when you tell them you are a victim of identity theft. From personal exper

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

ence, I can tell you that Citibank is the worst of the bunch. “I’m sorry sir, it was YOUR social security number on the account so you owe the money, when can we expect a payment?” Maybe when hell freezes over?

At that point, the identity theft has al

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

ready happened, and you can plan on spending countless hours and probably some legal fees until many months or even years later, things are back to normal for you. But if that doesn’t sound like a good time to you, there are steps you can and should tak

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

TODAY that will make the act of someone stealing your identity much more difficult. Unfortunately, it will probably never be “impossible” but if the best you can do is “much more difficult”, then by all means go for it.

First of all, almost all of us

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

et junk mail – great insurance rates, new mortgage program, car loan offers, and much more. If you look at the content of some of that mail, you would be surprised at the level of detail they contain – name, address, phone, date of birth, sometimes even

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

Following aspects would a

social security number. Take any and all junk mail that is addressed to you and SHRED it. You can get a decent shredder at any office supply store pretty cheaply. Shred that junk mail.

When you are working online, we all know that there are some gre

dd to the challenges in developing combination products:

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

t deals that can be had online. But just because a web site is designed well with attractive colors does not automatically mean that the vendor can be trusted. Heck, most 12 year olds today can create a very professional looking web site, so just think

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

of the site that could be created by someone intent on identity theft. One great way to protect yourself when purchasing online is to use a debit card that has ONLY enough money on it for the current transaction. Anything costing more than that will n

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

t get approved. Just before you make a transaction, you can transfer funds from your regular credit card or checking account to this single-use debit card, and only transfer enough to cover the current transaction. NEVER give your social security numbe

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

to an online site. It is never a requirement, and if they insist it is, you should surf in the other direction as fast as possible.

With the emails you get, NEVER open an attachment if you don’t know who the email is from. And if there really is a “c

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

Professional from academic institutions, pharmaceutical industries, health care indust

omputer problem” with your bank or investments account, they will NEVER ask you for your password or personal information from an online form. This is known as “phishing”, and it totally blows me away to see how many people fall for such a thing regular

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

y. If you go to their online form, which may look exactly like the one your bank actually uses, once they have your password and other personal information, you are toast and can look forward to months of trying to get your very own case of identity the

.

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

ft resolved.

In summary, just apply some LOGIC to it. Shred that junk mail. Use spam filters for your email. Do not divulge personal information via an email request from your bank, since they will never ask you to do that. Never open an email attac

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

Companies that provide selfless information through particip

ment from somebody you don’t know, even if the filename of the attachment has your mouse finger twitching out of curiosity. Be smart about your personal information, and remember that identity theft is no picnic and a LOT of work to get straightened out

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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In this story of sled dogs in Northern Canada we see how the conditions created by the driver, or manager, of the team have a significant effect on the ability of their team to perform. The louder the manager shouts the worse becomes their performance. There are many managers who could benefit from understanding the above through this simple story.

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