Advice You - Business

A rose by any other name would smell as sweet. Or so the saying goes. Well, what may be true for roses doesn

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

’t always hold true when for other things in life. Many, when we call them what they are, become quick turn-o

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

Examples of combination products may in

fs.

What got me started taking a second look at what we call all kinds of things was a nicely done TV commerc

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

al for a sleeping pill. At least I assume it’s a pill. It could also be a powder, perhaps even a liquid. Bu

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

, never having taken it, I don’t actually know. Nor do I care. I sleep quite well, thank you.

The point is

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

Combination pro

his: What caught my attention as someone who earns his living massaging words – writing marketing and corporat

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

e communications copy, actually – was this commercial’s offer of a “7 Night Challenge.” Now, what in the heck

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

might that be? The spot goes on to suggest – like so many medicinal commercial these days – that you “ask you

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

doctor” for the details.

Someplace in the back of my mind lurks the suspicion that a “7 Night Challenge” is

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

free trial of some sort, or perhaps a deep discount on a trial-size purchase. If it is a free offer, why not

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

say so? “Free” has for years been grabbing more people’s attention than virtually any other word in our langu

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

Following aspects would a

age. And, even if it’s only some kind of discount, however steep it may be, why not say so. “Save X%” or “Sa

dd to the challenges in developing combination products:

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

e $X.00” has always worked before.

Could it be that times have changed, at least as it relates to things medi

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

inal? When you think about it, it makes sense. It’s OK to “Save 25%” on tires. Or to “Save $10.00” on a $30

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

sweater. (Yep, always include that decimal point and those two extra zeros to make the savings look like more

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

than what they actually are. Right?) But neither approach seems to fit well with something as important or a

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

Professional from academic institutions, pharmaceutical industries, health care indust

s upscale as a peace-inducing, sleep-inducing medicinal product.

Therein lies a lesson for all of us who atte

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

pt to write great copy – whether for broadcast spots, Websites or even news releases – something we must const

.

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

ntly be aware of. The words we use, the tone we establish, the attitude we convey, must at a minimum fit the

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

Companies that provide selfless information through particip

tature of the product or service we’re describing. Better yet, our words should serve to enhance that stature

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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