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The Can Spam Act was passed in 2003 and was one of the first laws to control spam. There is much controversy surrounding this law; many people believe it is a victory fo

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

r e-mail users who are worried about risky spam, and others feel that it is a green light to certain spammers who want to foist aggressive advertisements on consumers.

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

Examples of combination products may in

he law is quite strict about illegal activities, but seems to allow loopholes for regular commercial business whose spam many e-mail users also find annoying. Still othe

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

rs greet the law as a first step in bringing the battle against spam into the public sphere.

The Can Spam Act stands for Controlling Assault of Non-Solicited Pornograph

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

and Marketing Act. Those who must follow this law are all those who send commercial e-mail that promotes a service or product. Sending mass advertising is permitted as

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

Combination pro

long as the information is not false or misleading and doesn’t involve any illegality.

The agencies with the jurisdiction to enforce the Can Spam Act are the FTC (Feder

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

l Trade Commission) and the DOJ (Department of Justice). These agencies can enforce criminal sanctions against those who violate this law. Federal and State agencies can

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

also serve as watchdogs and to take care of spam problems.

Under the Can Spam Act, businesses are not allowed to use misleading information in their headers, and canno

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

use false headers as “hooks” to lure someone to open an e-mail that contains information that is different from that suggested by the header. The e-mail must give the r

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

ecipient the opportunity to state that he or she does not want to receive any more e-mail promotions from that company.

Once the recipient has ordered the sender to sto

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

sending e-mails, the sender is given 10 business days to cease from sending e-mails to that person. Under the Can Spam Act, it is illegal to sell e-mail addresses to ot

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

Following aspects would a

ers.

Activities that are strictly prohibited under the Can Spam Act include: using other computers as spam zombies, selling e-mail addresses from those who do not want

dd to the challenges in developing combination products:

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

to be contacted, labeling sexually explicit material as something else with a deceptive header or subject line, and harvesting the net for private information about indi

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

iduals, including e-mails. These activities can lead to a $11,000 fine or jail time.

Many people were heartened by this law, while others were disappointed. The reactio

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

ns were often opposite of those expected. Many spammers who simply promote their business with mass, unsolicited e-mails, but do not create spam zombies or engage in ill

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

gal activities, applauded the law as a legitimization of their business practices.

Many Californians who wanted to make all spamming illegal in their state were disappo

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

Professional from academic institutions, pharmaceutical industries, health care indust

inted by the laws’ leniency regarded unsolicited marketing. However, even those who were disappointed saw it as a first step toward spam regulation.

Some wonder about t

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

e effectiveness of the Can Spam Act, and indeed, about the viability of attempting to regulate the net at all. Many people receive so many spam e-mails that they do not

.

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

have the energy to report every case that appears.

Similarly, agencies are usually swamped with complaints, and can only deal with the most serious cases. Therefore, so

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

Companies that provide selfless information through particip

e believe that this is the reason the law only deals with dangerous spammers rather than with annoying ones. So, at least for now, it looks like spamming is here to stay

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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