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I was purchasing a camera for my business at a well known warehouse store when I presented my American Express card along with my a

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

ssociate’s membership card. The associate was standing next to me at the time.

The clerk brusquely declared I couldn’t pay for the

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

Examples of combination products may in

item with my card because it wasn’t my picture on the membership card. Of course, I have had no problem doing the same thing in the

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

past, which made me wonder if this rule was being selectively enforced.

An instant after barking out, “Please call your manager,”

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

nd receiving a shrug from the clerk, I said, “Better yet, let me have my credit card back. I’ll try another line.”

Sure enough, tw

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

Combination pro

nty feet away, I entered a line manned by a clerk who probably has heard about “rules” somewhere at some time, but who looked so la

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

d back that he’d never want to enforce one.

I zipped through with my purchase, unmolested.

Next, I went to a supermarket and deci

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

ed to take them up on their 10% off for a “six-pack of wines or spirits or champagne” as the handy carrier advertises. The clerk wo

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

ldn’t give me the price break because I had a mix of wines and spirits.

She declared with utter certitude: “It must be all wines!”

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

I said I didn’t want to hold up the line and I’ll straighten it out with a manager, which I did, literally pointing to the languag

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

of the offer on the cardboard six-pack. He handed me seven dollars and change.

My associate, who had accompanied me on these back

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

Following aspects would a

to-back shopping sojourns quipped, “This is just like the Soviet Union! You had to fight for every bit of service there and be on y

dd to the challenges in developing combination products:

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

ur guard so people wouldn’t make up or enforce rules as they pleased.”

Of course, this got me to thinking that she’s absolutely ri

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

ht. Clerks at more American stores and on more phone lines are sounding like dictators. Instead being the golden era of customer se

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

vice which all of the ads would make us believe, we’re sinking further and further into a bureaucratic morass where fewer front lin

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

people have any idea of the value of a customer.

For seven bucks the supermarket chain risked losing my patronage, worth thousand

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

Professional from academic institutions, pharmaceutical industries, health care indust

every year. The discount club clerk made it seem that the photo on the membership card was more important than selling a $600 came

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

a.

What’s the solution?

Instead of hiring bargain basement help and then keeping them ignorant and allowing them to offend, manag

.

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

ment, when it hasn’t also been downsized or outsourced, should train and supervise their people so these absurdities diminish.

By

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

Companies that provide selfless information through particip

he way, my associate tells me customer service is improving in the former Soviet Union. They got the message.

Too bad we forgot it

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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