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As an elder law attorney I am frequently faced with adult children who realize that they simply have to take over for an aging parent. Maybe the parent is fallin

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

g behind on bills or has trouble dealing with the medical establishment. It is always hard for a "child" to become the caretaker of the once-powerful and dominan

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

Examples of combination products may in

parent.

Unfortunately, the parent may be reluctant to sign a power of attorney empowering the child to make legal decisions for the parent, since that act is f

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

equently seen as an admission that the parent may actually need such help. Combine that with the child's reluctance to bring up the subject for fear tha

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

t it may anger the parent, and you have a recipe for procrastination. Hence the all-too-common situation where the attorney has to decide if a parent (or spouse)

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

Combination pro

is too incapacitated legally to sign a will, trust, or power of attorney.

Let's start with wills. Many people are surprised to find out that a person with Alzhe

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

mer's or under a guardianship may still be legally competent to sign a will. That's because under the laws of most states, a person is legally competent to sign

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

a will if at the time of the signing he or she meets the following tests:

knows the natural objects of his bounty (i.e., is aware of his sp

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

use and children, if any)

comprehends the kind and character of his property (i.e., knows approximately his net worth and what kind of assets he owns)<

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

li>

understands the nature and effect of his act (i.e., realizes that it is indeed a will he is signing, and what that means)

is able to make a di

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

position of his property according to a plan formed in his mind

Thus, the lawyer must meet with the parent or spouse and try to discern the above. In

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

Following aspects would a

some cases, the lawyer may decide that the individual is too incapacitated and thus the lawyer must refuse to prepare a will.

A slightly different test is invol

dd to the challenges in developing combination products:

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

ed for signing a power of attorney. Here, the individual must be capable of understanding and appreciating the extent and effect of the document, just as if he o

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

she were signing a contract. Thus, the parent may be competent to sign a power of attorney, but not competent to sign a will.

A trust is sometimes deemed to be

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

more like a contract than a will, so that the necessary mental capacity needed to sign a trust may be less than that needed to sign a will. Recognizing that in

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

oday's world living trusts are most often utilized as "will substitutes," some recent state statutes have made the test for a trust the same as that set forth ab

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve for a will.

The mental capacity to sign the document should not be confused with the physical ability to sign one's name. The law will perm

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

it a person to sign an "X" (known as a "mark"), that, so long as properly witnessed, will suffice just the same as a signature. In addition, if even a mark is no

.

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

possible for the individual to make, then the individual can direct someone else to sign on his or her behalf.

Of course, the best advice is not to wait until

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

Companies that provide selfless information through particip

t may be too late, but to have those conversations with family members while they are still competent and able to comprehend exactly what they're signing and why

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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