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How many times have we run afoul of film producer Samuel Goldwyn’s famous maxim: "A verbal contract isn't worth the paper it's written on"? (I’ve certainly done it). And yet, isn’t life

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

nicer, simpler when you don’t have to worry about creating a paper trail? Why not just trust the people you’re doing business with? Isn’t my word my bond?

"Jared" had had the same attitu

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

Examples of combination products may in

e. Jared is an easy-going computer geek, more interested in creative problem-solving for his tech support clients than printing out every possible piece of paper to cross "t"s and dot "i"s

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

That said, Jared had a written lease for his office space, under which he was responsible for paying his share of real estate taxes. Last year, the taxes skyrocketed. So when he receive

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

the bill, he called the landlord (a college classmate) to work out a payment plan, instead of paying the taxes in a lump sum. Because they were friends, Jared didn’t confirm his agreement

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

Combination pro

in writing, thinking the landlord agreed to the arrangement. Yet months later, the landlord imposed late fees for the delayed payments, and Jared faced fines totaling several thousand doll

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

rs. Ouch!

Agreements do not always have to be in writing to be binding and enforceable. But the most important thing to remember about verbal agreements is this:

For verbal agreements t

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

o work, they require the complete, accurate, and fair memory of both sides.

Which, in reality, rarely happens. Memories are selective. And fallible. And faulty. Have you ever had a cli

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

nt who ignored your advice, made a mistake, and then blamed you for not telling her about the potential pitfalls? Welcome to selective memory. A vendor who provided you with thirty (30) i

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

ems instead of the thirty-eight (38) you needed? Hello, fallibility. People remember what they want to remember, which usually is not in your favor. Ever had trouble remembering the name

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

of someone you met repeatedly at networking events? You can thank your faulty brain cells.

There are a number of significant deal points that Jared and his clients might recall differentl

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

Following aspects would a

, because of selective, fallible, or faulty memory, such as:

1. The number of hours of computer tech services that Jared would provide
2. How much time Jared would have to respond t

dd to the challenges in developing combination products:

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

a technology "emergency"
3. How much Jared would be paid and within what time frame
4. Whether an agreement would automatically renew unless cancelled within a particular time

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

rame
5. Whether there would be penalties for non-payment
6. Whether, as with the landlord, they decided to make any changes to their previously agreed-upon relationship
7.

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

If there were any special arrangements that were not standard in the industry, such as the whether and how much interest Jared wanted to charge on outstanding balances
8. How you wou

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

d handle disputes, if any arose

Any one of these areas can create a contentious "he said, she said" situation if your respective memories don’t agree. And these are the "honest mistakes."

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

Professional from academic institutions, pharmaceutical industries, health care indust

Verbal agreements give you little defense against those who would actively seek to "burn" you, if that’s the scheming way they choose to conduct their business.

Finally, don’t ignore the

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

osts to your personal relationships if you are doing business with family or friends, as Jared did. People tend to take for granted that their friends and relatives are "on their wavelengt

.

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

" when it comes to doing business. Especially with closer relationships, do not assume anything. Be extra careful to treat the deal like you were working with a stranger. What you risk i

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

Companies that provide selfless information through particip

not only the deterioration of the business relationship, but the personal one as well. That’s a high price to pay, when it could have been solved easily and wisely by putting pen to paper

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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