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Are you a gambler? Do you like to play the odds? Here are some real-life odds for you to consider: 90% of people become incompetent before they die! Of course, your spouse might not think you’

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

re of sound mind right now, but that’s beside the point! If you don’t take action, you could needlessly cost your spouse thousands of dollars and countless headaches in order for them to make

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

Examples of combination products may in

ecisions on your behalf.

Competence refers to the ability to make rational decisions about your affairs. For instance, if you develop Alzheimer’s or dementia as you age, you’ll become incompe

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

ent. Two critical areas are affected by incompetence—your ability to make your own financial decisions and your ability to make your own medical decisions.

Unless you give someone the ability

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

to make these decisions for you prior to becoming incompetent, it will be left up to a court to decide who should make these very personal decisions for you. The person the court appoints may

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

Combination pro

ot know you very well and, as a result, the decisions they make may not reflect your desires.

There’s a simple way to protect you and your spouse. You can legally name someone you would want

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

to make these decisions for you ahead of time. Then, should you become incompetent, that person you named can step in and make decisions for you without the involvement of the courts. You choo

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

e them. You can also make them aware of your wishes to better insure they are carried out. If you are single, this is even more important!

The legal document that accomplishes this is called

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

Power of Attorney. I recommend each person have one Power of Attorney that covers financial decisions and a separate Power of Attorney that is used solely for medical decisions. That way, you

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

can name someone who is financially minded to handle your money matters and someone more compassionate to handle your medical decisions.

There are two types of Powers of Attorney (POA)—Genera

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

and Durable. The General POA gives someone the ability to make decisions for you while you are competent. The Durable POA is only active while you are incompetent. Many of my Private Wealth M

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

Following aspects would a

anagement clients are concerned about keeping control as long as possible, therefore, most of them rely on the Durable POA. By the way, most Durable POA only spring into action based on letter

dd to the challenges in developing combination products:

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

from 2 physicians attesting to your incompetence.

Some people think their children will be able to make medical decisions for them should they become incompetent, they can’t without a POA. S

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

ouses can make medical decisions for each other but that’s it. One spouse cannot make financial decisions for the other spouse. For example, if I were to become incompetent my wife, Julie, wou

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

d not be able to give any instructions or effect any transactions within my retirement account unless she had a POA (she does).

One of my newer clients now wishes he heard this several years

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

go. Chuck and his wife have been married forever and are in their early 80’s. About 3 years ago Chuck noticed that his wife was becoming a little forgetful. Dementia had begun and she slowly l

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

Professional from academic institutions, pharmaceutical industries, health care indust

ost her mental capacity. Like most couples, the real estate they own is in both of their names. That way it will automatically go to the other spouse should one pass away.

Unfortunately, Chuc

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

does not have a Power of Attorney over his wife. No one does. Therefore, he can’t sell any of the real estate to use the money to help pay for her care. He doesn’t have the authority to sign

.

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

n her behalf and since she is no longer competent, she doesn’t have the legal capacity to sign for herself!

To correct this, Chuck will have to go before a court to become her conservator—a l

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

Companies that provide selfless information through particip

ng drawn-out process that is humiliating and cost thousands and thousands of dollars. He will then have to appear before the court each year for the rest of her life to account for his actions

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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