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These are the nights when schools around America are filled with Harry Potters, soldiers, Draculas, and Disney princesses—at least those schools that still observe Halloween. There may be para

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

des, parties, and picture-taking—and enough candy to keep dentists’ chairs occupied for the next year.

But this Halloween I find myself contemplating something scarier than any Halloween frigh

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

Examples of combination products may in

mask—even a Nancy Pelosi “Speaker of the House” mask. It’s the thought of how money is spent in the name of educating the next generation.

A survey cited by National Public Radio in 2004 sho

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

ed that 47 percent of schools teach something dubbed “abstinence-plus.” The theory behind this sexual school of thought is that, while abstinence is best, some students will simply refuse to a

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

stain, so schools should teach kids about condoms and contraception as well. But, at a time when technology is advancing faster than our hands can fly across a computer keyboard, should we re

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

Combination pro

ally be spending part of the school day teaching kids how to put on condoms? If parents are responsible for ensuring that their children are potty-trained by kindergarten, shouldn’t it be up

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 parents to make sure their offspring learn about the birds and the bees?

Or consider this: A national poll reported by CBS News two years ago indicated that Americans don’t believe in human

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

evolution. Fifty-five percent said God created humans in their present form, i.e., no apes were involved in the creation of man and woman. And yet, school districts throughout the U.S. contin

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

e to waste their precious resources teaching children that man evolved from monkeys. It seems to me that, if a child believes that he or she has an ancestor who’s an ape, he or she is more lik

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

ely to behave like one.

And then there’s the biggest money-waster—the failure to teach children the difference between right and wrong. The fancy name for the problem is moral relativism. It

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

s a concept that’s preached in the mainstream media everyday: “No one should force his or her moral values on anyone else…That’s your truth, but not my truth…Don’t post your Ten Commandments h

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

Following aspects would a

re.” There is a religion taught in public schools—it’s just not the Judeo-Christian kind. It’s a religion dedicated to the principles of the American Civil Liberties Union and the National Ed

dd to the challenges in developing combination products:

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

cation Association. God is irrelevant; the state is divine; and everyone should take an oath of “tolerance”—meaning an acceptance of whatever kind of deviant lifestyle is being promoted at the

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

moment on television.

Why not spend some of our tax dollars teaching schoolchildren that life really means something—that every child in the womb deserves a chance at life? Let’s face it—if

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

ou teach a student that killing an unborn child is acceptable, what’s to prevent that child from growing into a teenager who thinks it’s O.K. to pick up a gun and shoot someone? It doesn’t mat

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

er whether the weapon is a semi-automatic or a scalpel—a killing is a killing.

In the kind of school budget that I’m proposing, we’ve cut out money for condom education, evolution propaganda,

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

Professional from academic institutions, pharmaceutical industries, health care indust

iberal indoctrination, and abortion promotion. That leaves quite a bit of money left. And we should be using that money to make schools safer and teenagers more disciplined.

Let’s take some

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

of the leftover cash and spend it on metal detectors. After all, a middle school student’s life is just as precious as a business traveler’s. If we care enough about airborne terrorism to pla

.

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 metal detectors in airports, we should care enough about school-based terrorism to install detectors in schools. It’s a shame that we would have to take this step but, with school shootings

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

Companies that provide selfless information through particip

becoming a routine part of the headlines, it’s now necessary.

And finally, let’s devote some money for boot camps for teens. It’s the only way to get some teenagers in shape—and out of prison

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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