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There are many misunderstandings about Estate Plans and who should have them. Many people think that an estate means a large tract of land and great wealth and extensive personal property that is very valuable, su

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

ch as vintage antiques and collectibles. Although this can be true, ‘estate’ does not mean the same to everyone.

In a recent version of Webster’s Dictionary, there are three definitions for the word estate: 1) a

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

Examples of combination products may in

condition or stage of life; 2) property; possessions; and 3) a large individually owned piece of land containing a residence. Although definition number 3 hints at this description, the other two have nothing to d

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

o with “a large tract of land”. Definition 3 names ‘a residence’, but it does not indicate the type. According to definition 3, an estate could actually be a one-room shack sitting on very little land.

According

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

o these definitions, an estate can mean simply the property and / or possessions of a person. When someone dies, the property and possessions are rightfully passed over to the next of kin – or disposed of accordin

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

Combination pro

to the directions left by the deceased. If no directions have been defined, the state laws determine this division of the estate, regardless of its size.

An ESTATE PLAN is the desire and intent of how all assets

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

and property will be transferred from one person (or couple) to the next person (or generation.) A will can be one component of an estate plan, but it alone cannot effectively complete the estate plan.

A will na

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

es whom you want to handle your final affairs or to receive assets that are titled in your name. However, most people don’t know that a will only controls the assets that are titled in your name. It does not contr

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

ol assets that are titled in joint ownership and go to your spouse or another joint owner when you die. It does not control assets with beneficiary designations for retirement accounts, such as IRAs, Roth IRAs, An

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

uities, 401(k), 403(b), Profit Sharing plans, or life insurance policies.

A will does not go into effect until one is deceased. A properly executed Power of Attorney is needed for the time between when one can no

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

longer handle one’s own affairs and death. Oftentimes a will is sufficient to handle all the affairs of one’s estate. However, it is important that each will be specifically designed and properly executed for ind

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

Following aspects would a

ividuals with specific situations and circumstance in mind.

Another component or tool for estate planning is the use of titling assets in joint ownership. Most married people title assets together as “joint tenan

dd to the challenges in developing combination products:

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

s with right of survivorship” (commonly abbreviated JTWROS). This leaves the entire balance of all assets to the surviving joint owner. It is a simple and effective tool that easily handles homes, automobiles, and

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

checking accounts. It is important to note that this designation supersedes the will.

There are several other possible techniques and practices to incorporate into an estate plan. Some utilize the practice of “G

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

fting” assets to another party while one is still alive. There are important tax considerations surrounding gifting that must be discussed with a competent tax advisor.

A Revocable Living Trust is another alterna

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

ive or addition to a will in an estate plan that is more comprehensive. This trust is its own entity like a person or a corporation. It is called a Revocable Living Trust because it is established while one is liv

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing and can be changed or “revoked” by the donor at any time. Since the assets are then owned by the trust, probate is avoided because the assets never change hands again unless final instructions of the trust are

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

to distribute them to a named beneficiary.

Another decision in estate planning is to do nothing. If one dies with no valid will in place, one is deemed to have died “intestate.” Although beneficiary designations

.

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

will be honored, the laws of the state in which one owns property or assets will control all probate assets. This lack of control may cause assets to be distributed in an undesirable manner.

It is important to ha

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

Companies that provide selfless information through particip

e financial, tax and legal professionals work together to help you create an estate plan. A complete Estate Plan includes all of the items discussed above, working together to develop an effective course of action

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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