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Imagine you're a Special Op's Marine in Iraq. They're known as Force Recon. You're patrolling in the dead of night along the Tigress River. You're in a Humvee with three others, lookin’ for bad guys. It's hairy work. You often end up in the river inside

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

your Humvee. You gotta' get out right now!

But wait a minute, the door won't open. You know why? Because the sucker weighs 500 pounds! That's with all the new armor plate placed on it, thanks to the news media and incompetent leadership that allows this

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

Examples of combination products may in

kind of thing to happen. What does it all mean if you’re a Force Recon Marine?

Not to worry, there is a standard operating procedure for everything. You’re highly trained so what is one more nonsensical order. Our Force Recon Marines are scuba trained.

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

hey now carry scuba tanks (yes, in the desert) at the ready, in their Humvee’s. If they should find themselves in the water and in need of exiting their vehicle, they just suck air from their scuba tanks, find the special little shape charge they carry f

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

or this purpose and simply blow open, yes blow open, the 500 friggin’ pound door. Unbelievable! But it’s happening in our 'war on terror' as we speak. Do you think these warriors might be a little cynical?

As a young Marine back in 1965 a few months out

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

Combination pro

of boot camp I found myself in Santo Domingo, Dominican Republic. It was in response to a Grenada like uprising in the filthy streets of the old Dominican city. It lasted maybe four days. I lasted one day before being wounded in the first act of politica

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

correctness I’d experienced. It was the first time I saw the stupidity of our modern version of war. It probably all began in the Korean War, whose participants in this country are truly the forgotten warriors.

In Santo Domingo, the 'rebels' had taken

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

over the city in an attempt to overthrow the government. Our unit’s assignment was to go in and take back the radio station while other Marine units and the 82nd Airborne attended to other duties. Our rules of engagement for the conflict were that we cou

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

d not use anything larger than our M-14's, an M-60 machine gun or grenades. That was it.

We were all young and didn’t know what we didn’t know, so off we went off full of adrenaline and excitement. We were crossing a couple hundred meters of dirt, advan

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

ing towards an old two story wooden building, when we were raked with machine gun fire. We did what Marines do, a frontal assault. It was really scary. They pinned us down for awhile but we advanced through the fire and eventually took the gun out.

Here

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

is where it is well to note we had tanks. The big ones like in the movies. They could have removed the machine gun raking us with one big round of fire. But rules are rules and we assaulted the old way, pretending we didn’t have superior fire power, and

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

Following aspects would a

the result ... four killed and thirty-six wounded. All self inflicted wounded because of our own rules of engagement. But I am proud to say we didn’t damage that old, dilapidated building.

The current Marine sniper ‘rules of engagement’ in Iraq is a boo

dd to the challenges in developing combination products:

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

let twenty-eight pages long. That's a short story. In Iraq the number of Marine snipers killed is approaching thirty. In Vietnam where I was a Marine sniper for two consecutive years, in all the years over there we didn’t have half that number. Our leade

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

s would say "it's a different kind of war". It is different, political correctness has gone mad.

I doubt that the Marines landing on Iwo Jima had a twenty eight page rules of engagement booklet. I doubt that the soldiers storming the beaches of Normandy

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

had JAG legal officers over their shoulders second guessing their every move from back in the land of Starbucks and 31 Flavors. It is awful for these brave young men and women.

One soldier recently told me of being on a patrol in Baghdad trying to set

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

p defensive position using concertina razor wire and was stopped by a higher up who said, "You can't use that, it looks too aggressive." Last time I checked you win wars by imposing your will on the enemy. Too aggressive, that’s BS?

If we’re going to wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

the war on terror it’s not going to be under the direction of the low life John Edwards types, standing back cherry picking everyone’s action, then trying to use our western laws against our fighting men and women. We’re civil people but war isn't very

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

civilized. It's a dirty business. If you’re going to commit our nation’s youth to battle then turn them loose and let them do the job. Bush wants a troop surge, send home the lawyers, make the bureaucrats in the green zone get out in the field and you ha

.

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

e enough troops to win the war.

It is time to let your Congressman and Senators know that the political correctness of the war on terror is costing well over half the lives lost ... ask any returning vet. A young late thirties CIA dude home for a month

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

Companies that provide selfless information through particip

rom Iraq, told me recently that it is far easier to arrest someone for drunk driving than it is a terrorist in Iraq. As Dr. Phil would say, “How’s that working for you?”

Come on America, wake up and make our leaders either do this thing right or get out

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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If your inbox is anything like mine, you've probably received your fair share of Product Resale Rights offers. Often times you'll be offered anywhere from one to a hundred or more products, ranging in price from $17. to $500. Trying to figure out What You're Allowed To Do with them can be a confusing process.

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