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So you've decided to run a print ad in your local newspaper. The

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

paper may have even told you they could produce the artwork for

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

Examples of combination products may in

you if you just tell them what should be in the ad. Problem is,

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

ou're not sure what should be in the ad.

The first thing you ne

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

d to do is answer the following question: What is your objective

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

Combination pro

for the ad? You need to know what result you expect the ad to ac

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

omplish in order to determine what needs to go into the ad.

Onc

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

you determine your objective (e.g. I want them to visit my stor

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

; I want them to call me for more information; I want them to ta

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

e advantage of my promotion) you can decide what needs to be in

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

he ad to successfully convince them to take this action.

The pr

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

Following aspects would a

blem I see with most ads is they lack focus. There is too much i

dd to the challenges in developing combination products:

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

formation and too much going on in the ad for the reader to be a

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

le to clearly understand the primary message the advertiser is t

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

ying to impart.

Your goal should be to impart one SINGLE messag

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

. And that message should support your objective.

Keep your ad

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

Professional from academic institutions, pharmaceutical industries, health care indust

simple and to the point. You can be creative, but make sure the

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

eader clearly understands what you are selling, what you want th

.

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

m to do, and several ways they can take action (e.g. call, visit

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

Companies that provide selfless information through particip

your store, visit your web site, email).

(C) 2005 Debbie LaChus

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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