Advice You - Business

I have on my desk a direct mail fundraising appeal from a hospital that I once supported with a donation. I g

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

ave them a gift of $20 as an experiment, to see how, and how often, they would write back.

Across the front

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

Examples of combination products may in

f this envelope are these words: “Your 2007 Annual Renewal.”

A phrase like that wouldn’t normally surprise m

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

, or disappoint me, but it did when this package dropped through my mailbox back in February because that was

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

the first time I’d heard from this hospital since I made my donation. And I made my donation last year. In 20

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

Combination pro

6. June 12th, to be exact.

So do the math. I did.

I made my donation on June 12, 2006. I didn’t hear from t

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

he hospital again until February 20, 2007. Which means I was obviously off their radar screen for seven and a

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

half months. Although they were not off mine. I was watching for the mailman every day to see how they would

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

espond to my gift.

I can’t say I was disappointed with their response to my gift because they didn’t respond

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

to my gift. They ignored me. For seven and a half months. No letters. No newsletters. No phone calls. No emai

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

s.

Which is why the headline on their February appeal startled me.

“Your 2007 Annual Renewal.”

That headli

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

Following aspects would a

ne tells me that the hospital thinks I should renew my support, automatically. Regardless of how they treat m

dd to the challenges in developing combination products:

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

. But that’s where we disagree. This hospital needs to give me a reason to renew my support, and not just in

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

heir annual renewal letter.

Like most donors, I won’t support an organization for long that cares more about

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

my money than it does about me. I won’t renew my support of a charity that expects me to be uninformed and ge

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

erous at the same time. I won’t support what I don’t believe in. And I can’t believe in something that I don’

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

Professional from academic institutions, pharmaceutical industries, health care indust

t understand. And I’m not likely to understand the needs of an organization that writes to me only once every

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

seven months.

I pay my mortgage automatically. I renew my insurance automatically. I pay my taxes automatica

.

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

ly. I have many incentives for doing so. But I don’t renew my charitable support automatically. If you want m

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

Companies that provide selfless information through particip

to give again, give me a reason. A good one. And give me that reason long before you ask me to renew my gift

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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