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We've all become familiar with the term spam. It's become so commonplace that even people who

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

never use computers are familiar with the term spam. That single word has become part of our

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

Examples of combination products may in

every day vocabulary that we use in personal conversations.

But how does the word spam rela

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

e to email? There are two camps of thought on this matter. The classic version of the story s

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

tems from the classic Monty Python spam sketch where a couple enter a restaurant and are give

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

Combination pro

a menu that has nothing but the tinned meat spam on it. In that sketch the word spam is repe

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

ated almost 200 times. The same word repeated over and over in a sketch led to people referri

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

g to hundreds of the same emails about the same topic being referred to as spam.

The second

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

explanation came from a guy called Jim who told me the following story:

"Back in the BBS (Bu

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

letin Board System) days with the NEW high-speed V32 2400-baud modems it would take a very lo

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

ng time to download a program or picture from your BBS. This was much like USENET is today yo

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

Following aspects would a

u upload some thing and others can download it.

One such uploader advertised his posts as pi

dd to the challenges in developing combination products:

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

tures of nude women. After a half hour download and putting all the pieces together the pictu

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

re turned out to be a picture of a can of SPAM. Where are my nude ladies and an hour of my ti

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

e? People replied to the messages and wrote SPAM. This way we knew not to D/L that picture. 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

fter USENET got going the term stuck meaning something false - do not download (or believe) t

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

Professional from academic institutions, pharmaceutical industries, health care indust

is. The jump to UBE (Unsolicited Bulk Email) or UCE (Unsolicited Commercial Email) being call

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

ed SPAM was a natural evolution of the term."

Decide for yourself which origination theory b

.

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

st suits you. The principle is the same. The word spam is derived from the fact that the same

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

Companies that provide selfless information through particip

useless information is sent to you over and over again under the pretence of it being useful

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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