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"Mr. Micawber (said) to take warning by his fate; and to observe that if a man had twenty pounds a year for his income, and spent nineteen pounds nineteen shillings and six

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

pence, he would be happy, but that if he spent twenty pounds one he would be miserable."

Charles Dickens

David Copperfield

Dickens wrote David Copperfield about 160 year

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

Examples of combination products may in

ago. At the time a British pound was worth about $5.00, so Mr. Micawber was talking about an annual income of about $100. Now, while the value of money has certainly cha

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

nged over the last 160 years, the question is whether our attitudes towards money have also shifted.

People can get into lively discussions about what Micawber meant and h

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

w they feel about those sentiments. What he is saying is that if his income – over the course of a year – exceeds his expenses by just a tiny bit, he will be a happy man.

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

Combination pro

But if his expenses are a weensy bit more than his income, he is miserable. Micawber has a fixed rule about money and about the relationship between money and stress.

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

any of us have a very similar rule.

Is this a rational rule? I have a very good friend who has always lived by this rule. From the time he first started working, he made

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

sure that the size of his paycheck was always larger than his expenses. I don’t know if he would have been miserable if he broke the rule because he never, ever broke the

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

rule and it has worked well for him his whole life. He never bought anything on credit and, therefore, never paid interest on anything. Of course, there were many things

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

he either never bought or deferred buying for years, but he never felt deprived.

I have another very close friend who had a very different rule. His rule was “always be a

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

le to catch up.” He had no qualms about going into debt, but never got beyond his earning capacity. He ended paying more for many of the goods he enjoyed, because they co

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

Following aspects would a

st him interest, but he never wanted for those goods.

I also know people whose rule is “spend and pray.” They “bet on the come.” This works well in boom times and bull m

dd to the challenges in developing combination products:

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

rkets, but they suffer and scramble when things get tight. Then there are money Bulimics who alternate between being tight and spending little and bingeing, spending it al

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

l and even more.

Mr. Micawber lived a much more simple life than we do today. There were very few instruments of money. There were no credit cards and, aside from a bar

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

ab, very few means of managing debt.

Life today is significantly more complex. Many people have no idea whether they have more money coming in than going out! Both incom

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

e and outgo are more complex nowadays. We have IRAs and 401Ks, complex tax structures that only get resolved once a year. We have many forms of investments and we have ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

y forms of debt management.

But when you examine the quote, you may see that Mr. Micawber had another fixed rule about money. This second rule also dominated his life, ev

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

en more than the first and that rule was, “I cannot manage debt.” He may have said it another way, “I cannot be trusted with money.” Many of us have those rules, too.

We

.

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

all have rules about money

All of us act as if there were certain rules about our relationship to money matters. But we don't know that we act that way. I suggest you w

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

Companies that provide selfless information through particip

rite down your rules. Over the next week see when they pop up-How do you tip? How do you buy necessities? How do you buy presents? How do you save? What are your rules

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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