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The CAN-SPAM Act of 2003 specifically indicates what is not permissible when you are mailing

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

commercial email. The fines and penalties are stiff, do before you begin an email campaign,

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

Examples of combination products may in

be sure and understand the CAN-SPAM Act.

1) The CAN-SPAM act of 2003 specifically indicates

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 your heading and subject line must be truthful, and cannot be misleading. This include

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

s your to and from address lines – they must include accurate information. Also, your subject

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

Combination pro

line itself must accurately reflect the content of the email.

2) You must include a way for

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

your subscriber to opt out of your email list, and within a specific time frame. You can do

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

this by including a link within your email which unsubscribes them, in conjunction with your

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

autoresponder service. You cannot sell or remail these leads under any different name.

3)

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

All commercial email (and that includes just about everything you will be mailing, including

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

the content emails) must include a valid postal address.

4) You cannot harvest or collect e

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

Following aspects would a

mails from web sites for the purpose of commercially emailing them.

5) You cannot use autom

dd to the challenges in developing combination products:

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

ated methods of creating email addresses and then sending them messages to detect which are r

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

eal addresses and which are not.

6) You cannot use any kind of automated method of signing

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

up with different email accounts for the purpose of mailing commercial emails.

7) You canno

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

use another person’s computer or any part of another person’s computer system or relay syste

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

Professional from academic institutions, pharmaceutical industries, health care indust

m to send emails without their knowledge and consent.

To read the actual language of the act

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

, click here: http://www.ftc.gov/bcp/conline/pubs/buspubs/canspam.htm

It is extremely impo

.

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

rtant that you remain CAN-SPAM compliant. There are stiff fines and you can be prosecuted fo

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

Companies that provide selfless information through particip

r breaking this law, as well as prosecution for false advertising and other deceptive tactics

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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