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You elect your local trustees, be they for your village, your schools or your library. For most people, the closest contact they ever have with their elected officials is at the ballot box. Maybe

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

you saw an ad on a neighbor's lawn and the picture looked good, so you voted for that candidate. Or maybe you actually do know the candidate personally and you like him/her. So you check the box t

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

Examples of combination products may in

o vote him/her into office.

I happen to be an elected member of the Nippersink Library District board of trustees. The reason I am there is that I've always loved my local library; I've always fo

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

nd it to be a warm place (or cool in the summer) where I can pick up the local newspaper and read it - relatively undisturbed. Or I can peruse the latest novels. I can also borrow DVD's and audio

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

books to keep me company when I'm in my car. And I felt that I needed to become involved in my community. I'm always amazed at the number of different things you can do at the library. So I ran fo

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

Combination pro

r the office and won (unopposed, I should add).

I have also attended village and school board meetings. But that was always when I had a burning opinion to relay to the boards. For instance, in 1

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

99 the village of Richmond was scheduled to vote on whether a parcel of land next to my property should be annexed and rezoned. I was against it. So were a whole bunch of other citizens in Richmon

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

d who attended that meeting. The village board passed the annexation over our objections, or, it seemed to me, to spite our objections.

I had similar experiences with our school boards. No matter

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

how many people showed up for a particular meeting, we always felt that the school board trustees turned a deaf ear on our appeals. Or as the grade school superintendent said, "We agree to disagr

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!" Well, hot damn!

Earlier this month (July 2002) the Richmond Zoning Board agreed to recommend the annexation and rezoning of a hotly contested piece of property to the village board. Two citiz

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

ens, Rommy Lopat and John Drummond, took it upon themselves to hire a few high-priced attorneys and city planners. They attempted to give the village board a different perspective about the annexa

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

Following aspects would a

tion than what the board was hearing from the developer the Village President and the Zoning Board President.

This was a beautiful thing to watch. Fifty or so village residents filled the meeting

dd to the challenges in developing combination products:

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

room and they were allowed to express their opinions. The result was that the board voted to delay their decision until September so that they might be allowed to review the information that was p

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

resented.

At first I was elated. Then reality set in. I began to realize that to fight power you need power. Money equals power. What if Rommy Lopat and John Drummond could not afford to bring in

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

expert witnesses? I think the citizens would have been quickly rolled over and buried. This is the way, I realized, that government works. You must have power to be heard.

The awful truth is tha

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

I leave the meetings feeling that we had just done battle with the opposition. We always lost. I felt that the outcome was predetermined, that the board attitude is a bit condescending. I do beli

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

Professional from academic institutions, pharmaceutical industries, health care indust

eve that, generally, boards feel they have a duty to the public to help the public, but I think they also think that we citizens are uneducated and bothersome, like mosquitoes which must be squash

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

ed to be quieted.

Maybe your local boards DO listen to you. Maybe Richmond's boards are the rare exception. But I think not. I think that most boards around the entire country reflect the attitud

.

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

s of the Richmond boards: the citizens are nuisances to be endured because the law says they must endure us.

Why are the boards so adversarial in nature? Does it have to be that way? Do we not, a

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

Companies that provide selfless information through particip

s taxpaying citizens, deserve to be listened to CAREFULLY and HONESTLY?

It's time to stand up and be counted, folks. Do go to your local board meetings, if only to show them that you are watching

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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Michael Sakowski endured numerous ups and downs in his affiliate marketing efforts, but finally found a path to a stable income through information marketing utilizing contextual advertising.

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