Main Subject - Internet and Businesses Online

Consider the following three claims:

1. Your e-mail is not private.

2. Your e-mail might not be sent to the intended recipient.

3. Your e-mail can continue to exist even after you delete it.

The fol

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

lowing article explains the truth of these alarming statements and why you should be concerned if you're sending confidential messages by e-mail.

1. THE PRIVACY PROBLEM

When you send an e-mail message

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

Examples of combination products may in

from computer A to computer B it passes through one or more machines (C, D, E, etc.) on its journey. At each step along the way, an unscrupulous individual with access to the intermediate machine has t

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

he opportunity to read -- or even alter -- your e-mail message.

Within a private intranet (i.e. a company network), such privacy violations could occur if:

* IT staff with access to the mail server we

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

re unscrupulous;

* unauthorised personnel had access to the mail server (e.g. if someone walked away from the server without logging out); or

* security measures designed to keep hackers out of the ma

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

Combination pro

l server were insufficient or were not enforced rigorously.

When e-mail is sent over the Internet (a public network) the risks become notably higher. If you send an e-mail message from Sydney to New Yo

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

rk it may pass through half-a-dozen machines on its journey, *each* of which are subject to the risks mentioned above. Thus the hazards accumulate with each extra machine that the message passes through

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

.

2. THE IDENTITY PROBLEM

Another risk with e-mail is that you really don't know who will receive it. This happens because some people choose to forward (i.e. divert) their e-mail to another person or

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

authorise another person to read it for them. For example, if you send a message to a senior colleague, remember that this person's e-mail might be read by his or her secretary or stand-in. That can be

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

awkward.

I know of a case where a manager sent an e-mail report to his CEO describing a clerical officer's poor performance. The CEO had, unfortunately, forwarded his e-mail to his acting secretary, w

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

o that day happened to be (you guessed it) the clerical officer in question. The clerical officer read the critical report, and all manner of morale problems ensued.

3. THE DELETION PROBLEM

A further

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

Following aspects would a

privacy issue surrounding e-mail involves what happens when you delete an e-mail message. You might expect that deleting an e-mail message removes it irretrievably. This is often not the case. though.

dd to the challenges in developing combination products:

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

In fact, it's a tough job to delete every copy of a piece of e-mail. There are many ways that a "deleted" e-mail message might still be accessible:

1. Daily or weekly backups of the mail server may sti

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

ll contain messages that were subsequently deleted.

2. When you delete an e-mail message, many e-mail programs simply move it to a trash folder, rather than actually deleting it. It's not until you sel

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

ect their "Empty the Trash" command (or similar) that the message is actually deleted.

3. Even after you empty your trash folder, many network-based e-mail programs still archive deleted messages for a

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

period of time before deleting them. During this archival period (30-90 days is typical) the message could be available to unscrupulous or unauthorised individuals.

4. Even after a file is deleted from

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

Professional from academic institutions, pharmaceutical industries, health care indust

a computer's hard disk, the information is often still available until that portion of the disk's surface is overwritten with new information. During this period the deleted files could be available to

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

unscrupulous individuals with physical access to the computer.

5. Even if you take steps to avoid all the potential problems above, remember that the e-mail message is probably still available on 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

PC of the person you sent it to (or who sent it to you).

4. CONCLUSIONS

The moral of this story is clear: e-mail is not a private medium. Don't send messages by e-mail unless you're comfortable assumi

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

Companies that provide selfless information through particip

ng that they may be read by people other than the intended recipients.

So next time you go to press that "Send" button, ask yourself "Am I okay with this being seen publicly?" If not, pick up the phone

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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