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Summary - Debunking Estate Planning Misconceptions
What does it mean to have no estate plan? What does it mean to have neither a will nor a trust? While you may have heard many "horror stories" and rumors, you may not truly understand the significance of not having formal estat
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
e-planning documents prepared.
Here are some of the misconceptions and attitudes many have about not having an estate plan:
Here are some of the misconceptions and attitudes many have about not having an estate plan:
- All of my money will go to the state!
- It's O.K. I don't need a will or a plan beca
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
use I don't have much money.
My estate is really simple. It's no big deal; I don't really need one.
I don't want to think about it -- eat, drink and be merry! Pass the hot dogs (or the wine, or whateve
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
r)!
I have come across many of these attitudes/misconceptions in many years of law practice -- except for the "I don't want to think about it" group, who usually call once and never make an appointment, or of course who m
I have come across many of these attitudes/misconceptions in many years of law practice -- except for the "I don't want to think about it" group, who usually call once and never make an appointment, or of course who m
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
y never call in the first place!
However, all of these attitudes need some serious debunking. All are flawed and all portray a major lack of understanding of the estate planning process. Consider the following answers to each:
However, all of these attitudes need some serious debunking. All are flawed and all portray a major lack of understanding of the estate planning process. Consider the following answers to each:
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
>Will all of my money go to the state if I die without a will or trust?
Rarely. While it is much better to have your own will, dying without a will is not fatal (Ouch. I'm sorry about that pun). It is called dying "intestate
Rarely. While it is much better to have your own will, dying without a will is not fatal (Ouch. I'm sorry about that pun). It is called dying "intestate
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
." The states have enacted statutes that apportion an estate among predesignated classes of beneficiaries when there is no will. For example, the laws of intestacy in California provide that when a person dies without a will his or he
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
estate (his or her separate property or community property share) will be split 50% - 50% between the children then living and the surviving spouse.
While the State of California can benefit from an estate, it is only the "heir
While the State of California can benefit from an estate, it is only the "heir
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
" of last resort. Property goes to the state when there are no known heirs at law (the transfer to a state's treasury is called "escheat").
Therefore, failing to have a formal estate plan involves both "good news" and "bad news." The
Therefore, failing to have a formal estate plan involves both "good news" and "bad news." The
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
good news is that state legislatures have provided a back up estate plan for those without wills. The bad news is that this state-sponsored estate plan is just that: It's the state's plan. It is not necessarily your pla
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
, and it may be the opposite of what you want.
Do I need an estate plan if I don't have much money?
Even if you do not have loads of cash or assets you should still have a will. Only then will you ensure that your asset
Do I need an estate plan if I don't have much money?
Even if you do not have loads of cash or assets you should still have a will. Only then will you ensure that your asset
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
s are transferred according to your wishes. Also, financial circumstances do change. If you do not believe that you have much money at this time, that situation could change in the future.
If you have children you clearly need a will
If you have children you clearly need a will
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
. The will is the common method of nominating a child's guardian. Crazy Aunt Millie could very well raise your child in the event of your demise even if she is the last person you would want for the task. If you do not tell the court
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
your wishes through a properly executed will, the court may do exactly what you do not want.
My estate is so simple. Do I really need to worry about all of this stuff?
Your estate may or may not be as sim
My estate is so simple. Do I really need to worry about all of this stuff?
Your estate may or may not be as sim
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
le as you think. Few estates involving real property assets are truly "simple." For example, if you own real property you would probably benefit immensely by having a trust. Probate filing fees and attorney's fees can cost thousands
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
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
of dollars -- costs which would probably be avoided should you place the assets into a trust.
Often the "simple" route is the expensive route.
Also, I have found that those who protest the most about the simplicity of their estate usu
Often the "simple" route is the expensive route.
Also, I have found that those who protest the most about the simplicity of their estate usu
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ally have very specific ideas concerning how they want their assets distributed. If you have very specific ideas about how your estate is to be apportioned, the intestacy statutes will not assist you.
Bottom line: You should consider
Bottom line: You should consider
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
iscussing the issues of distribution with your attorney. After doing so you might discover that there is a real benefit to planning your estate in a more formal manner.
I don't want to think about it! Pass those hot dogs!
I don't want to think about it! Pass those hot dogs!
.
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
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
b>
Estate planning conjures up a lot of emotions. And not all of those emotions are positive -- after all, planning for your own demise is tough! However, consider this: Planning your estate will not shorten or lengthen your life by
Estate planning conjures up a lot of emotions. And not all of those emotions are positive -- after all, planning for your own demise is tough! However, consider this: Planning your estate will not shorten or lengthen your life by
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
a single moment. So why not think about it and do it?
In fact, once the task is done, there will almost always be an instant relief. After all, planning your estate is not necessarily for you. It is for those you leave behind
In fact, once the task is done, there will almost always be an instant relief. After all, planning your estate is not necessarily for you. It is for those you leave behind
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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