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The Original Act

In the year 1991, Congress enacted the Telephone Consumer Protection Act or TCPA to keep a check on the increasing number of telephone marketing calls, which

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

can easily be termed as unsolicited. The act restricts the making of promotional calls and the use of automatic telephone dialing systems and prerecorded voice messages.

The

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

Examples of combination products may in

Act defines an “unsolicited advertisement” as “any material publicizing the business availability or quality of any property, goods, or services which is transmitted to any p

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

erson without that individual’s prior express request or permission, in writing or otherwise.”

Extending The Act To Cover Fax Broadcasting

Later, this Act was extended to fa

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

advertising. It was decided to restrict the use of the fax machines to distribute unsolicited advertisements. Specifically, it forbids the use of “any device to send an unsol

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

Combination pro

icited advertisement to a telephone fax machine.” The act is applicable to only those messages that constitute “unsolicited advertisements.” The legal prohibition applies to s

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

uch announcements sent both to residential and business fax numbers.

Exemption under Established Business Relationship

In 2005, the above Act was amended by the Junk Fax Pre

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

ention Act. The new Act now permits the sending of unsolicited fax advertisements to individuals and businesses with which the sender has an established business relationship

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

(EBR). An EBR implies formation of a prior or existing relationship between a person or entity and a business or residential subscriber, by a voluntary two-way communication.

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

This relationship can be made with or without an exchange of payment, and allows a person or entity to promote its products and services to a business or residential subscribe

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

on the basis of an enquiry, request, purchase or deal. EBR is supposed to be seized as soon as either party decides to terminate it. Specifically, a fax advertisement may be

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

Following aspects would a

sent to an EBR client if the correspondent also:

• Obtains the fax number directly from the recipient, either through, an application etc. or from the recipient’s own directo

dd to the challenges in developing combination products:

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

ry, advertisement etc. unless the recipient has documented on such materials that it does not accept unsolicited advertisements at the listed fax number.

• Obtains the fax nu

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

mber from phone books and other sources of information compiled by third parties – here the correspondent must take appropriate steps to verify that the receiver had agreed to

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

have the number listed in that source of information.

Opt out Provisions

It is mandatory for all fax messages to have a specified notice and contact details on the fax that

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

allow addressees to “opt-out” of future faxes from the sender. The message should be on the first page, be loud and clear and mention the process of opting out. In case the se

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

Professional from academic institutions, pharmaceutical industries, health care indust

nder fails to comply with the opt-out request within 30 days, legal sanctions can be initiated against the sender.

Netting the Fax Broadcasters

The person or business on who

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

e behalf a fax is sent is liable for a violation of these rules even if they did not physically send the fax themselves. A fax broadcaster may also be accountable for violatio

.

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

ns of the rules if it gets rigorously involved in the sender’s fax messages, such as providing the fax numbers to which a message is sent or distributing a repository of fax n

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

Companies that provide selfless information through particip

umbers. They are expected (and at times required) to make representations about the legality of faxing to those numbers and advising a customer about how to abide by the rules

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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