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Can you remember when all television was free? You simply pulled open the “rabbit ears” antenna and voila! You got four or five channels. Then an insidious newcomer came

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

into the marketplace with an intriguing premise; cable. It asked, why not pay for television that offered (a) better, static-free quality, (b) choices of various catego

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

Examples of combination products may in

ies, i.e. sports, travel, comedy. (c) less advertising, and (d) movies on demand. Most of us scoffed at the very idea of paying for TV, but look what’s happened since th

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

en. Now we also have satellite doing the same thing, and most of us can barely remember what free TV used to mean.

Why did we allow it to happen? Because it offered a b

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

tter, albeit, premium product. It was a choice we could make and eventually became part of our lexicon. Today, radio is going the same route. So why not look at the Inte

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

Combination pro

rnet with similar eyes? After all, it’s not really free anyway. You either have to have a phone line, cable, or satellite feed to hook up at a monthly cost. But, because

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

it provides your e-mail, search engines, and other informative sites, it’s money well spent. So the idea of going on pay-for sites is nothing new. You still have many fr

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

ee choices and that’s wonderful. It’s the free-enterprise system working at its best. Let the market dictate what will happen.

So why would you consider paying for a se

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

vice that can be obtained for free? Didn’t you learn anything from the cable TV example? What if the site provided really quality content that was up-to-date, easy to us

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 and access, and downloaded quickly even with dial up? Today, less than 20% of all Americans have high-speed Internet access. So many of the picture and advertising ban

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

er-heavy sites take forever to come up with dial-up connections. Perhaps you would enjoy a membership site that has no advertising at all, as was the promise of the plan

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

Following aspects would a

ners of cable TV. But in this case, let’s assume it’s true. Are there any examples of this concept in action?

It depends on the category. In the world of magazines and

dd to the challenges in developing combination products:

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

ewspapers, the obvious answer is, of course. Most printed publications like “The New York Times” charge for their online counterparts. After all, that’s how the print pr

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

oduct makes its money. There are various hobby clubs, how-to, and specialty sites that charge for membership. But what about important, life-saving information? What do

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

you do in a case like that?

There are many excellent websites that provide health and medical data from private and governmental sources. They are free, but do accept a

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

dvertising. In addition, the NIH, CDC, or Dept. of Health sites which are Federally operated, have limited libraries of information. For example, if you wish to investig

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

Professional from academic institutions, pharmaceutical industries, health care indust

te a disease, drug, vitamin, or herb, none of these sites can offer all the items you seek, even though they are free. So what does one do, in that instance?

You turn t

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

o a membership site that does have all the pertinent data in one place. Luckily for you, one such site does exist that also allows you to find physicians referred by nur

.

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

es.

It’s called, thenurseschoice.com and requires a nominal monthly payment that’s less than a cup of coffee. It’s also advertising-free like the old cable world and ea

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

Companies that provide selfless information through particip

sily downloaded by dial-up. So, why pay for information off a membership site? Perhaps because you value your health and the health of your family. And what’s that worth

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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