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I just listened to the President’s latest “major” policy speech on the Iraq War. My president is completely under the ideological pull of the neo-con black hole. I have

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

to let him go. And it is killing me.

I optimistically reasoned that maybe this speech would be different; possibly showing a slight crack in his blind obduracy. It was

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

Examples of combination products may in

n’t. It never is going to be. I’ve got to stop doing this to myself. The only thing remaining is the comic relief of Beltway Scott, as he entertains the press corps at t

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

oday’s White House briefing by doing that wacky word juggling thing he does.

I mean really, what did the President say that was so new, so revealing, so insightful? Wha

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

? Instead I saw another hand picked military audience listen enthusiastically to another slick emotional repackaging of the same old line: stay the course. And I heard o

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

Combination pro

nce again a stream of the same old flawed rhetoric: people who disagree are being political and undermining troop morale; an exit strategy is artificial and equivalent 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

o turning our backs on our allies; and cut-and-run would embolden the enemy and lead to more attacks against Americans here and abroad.

Again, he is full of crap on eve

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

y empty feel-good one liner (I couldn’t come up with a softer way to put it).

If I learned one thing from the Vietnam fiasco, it was that I can be against a war and mai

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

ntain an unyielding respect for the men and women soldiers who execute orders with their lives, not their politics. I did not understand that back in the late Sixties an

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

d Seventies. I was wrong, completely wrong, and finally, I have it right thankfully.

Regarding cut-and-run, who is suggesting that, certainly not congressman Murtha. He

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

talked of a measured reduction in troops based on the real results at certain benchmarks. It’s not cut-and-run and it’s not artificial. But it is the result of his uniqu

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

Following aspects would a

e access to honest military feedback. It is sensible and worthy of real consideration.

As far as tainting our reputation with our allies is concerned, what reputation M

dd to the challenges in developing combination products:

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

r. President? You took care of that when you paraded our most respected voice, Colin Powell, in front of the UN to proclaim one falsehood after another.

The sad fact is

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

that the only time Mr. Powell spoke a truth, Dubya chose not to listen: “you break it, you buy it”. And boy did we break it, into at least three big pieces as far as I

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

an tell.

Finally, any—and I mean any—future predictions of terror the president boldly barks out as certainties are suspect. I have no faith that the intelligence and p

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

rocesses Georgie uses today to reach these dark revelations are any better or any less scrubbed than the intelligence and processes that got us into this fine mess in th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e first place.

Here is what I think. Once the Iraqis vote their government into place in mid December, their very first piece of business should be a referendum about f

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

reign presence in Iraq. Let them determine their needs, and let their needs determine their request for support. If they choose for us to leave, so be it. Let freedom ri

.

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

ng. If they choose for us to stay the course, at least we will know we are wanted and why.

I could live with that.

What I can’t live with, is a bunch of hackling neo-c

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

Companies that provide selfless information through particip

ons knowing what is best for America and the world, arrogantly casting the lives of many into harms way—none of those lives being theirs or the lives of their loved ones

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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