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Top Articles - Estate - When The Battle Begins At Home
I received a heart-wrenching phone call from a young soldier recently. His mother had just died and he was left with the responsibility of settling her estate. He had no idea the difficulties he would encou
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
nter—not on the battlefield but here in East Tennessee. The worst part is it could have been completely avoided.
‘Brian’, an Army soldier was on his way to Haiti when he received a phone call that his moth
‘Brian’, an Army soldier was on his way to Haiti when he received a phone call that his moth
; 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
r was in the hospital. Her outlook wasn’t good. Forced to take emergency leave, he rushed home. Unfortunately, he was too late. She had already passed away.
His mother never talked with him about her plans
His mother never talked with him about her plans
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
so now he doesn’t even know if she had a Will. In the midst of dealing with an emotional loss and feeling the pressure to return to his unit as soon as possible, Brian has to make her funeral arrangements.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e also has to get her estate settled.
During his search, Brian came across one of my brochures and called me to see if his mother might have been one of my clients. Turns out she had attended one of my est
During his search, Brian came across one of my brochures and called me to see if his mother might have been one of my clients. Turns out she had attended one of my est
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ate planning seminars where she learned about the importance of planning ahead. She even scheduled an appointment, but unfortunately, she didn’t keep it.
There are several challenges Brian now faces. Funer
There are several challenges Brian now faces. Funer
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
l arrangements will be the first hurdle, but that’s just the tip of the iceberg. At her death, all of his mother’s financial accounts are frozen. So how is he going to pay her bills? He can’t use any of the
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
money in her accounts. That means he or another family member will have to use their own money to pay for things like utility bills, real estate taxes, etc.
Worse yet, who’s in charge? Brian is not an only
Worse yet, who’s in charge? Brian is not an only
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
child. At this point, no one legally has the authority to make any decisions affecting her estate. Who’s responsible for safeguarding her assets and securing her home?
When I spoke to Brian, he had already
When I spoke to Brian, he had already
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
tried calling several of the local banks to see if his mother had an account there. Thinking a Will might be in a safety deposit box, he was trying to see if she had one.
He wasn’t able to make any progre
He wasn’t able to make any progre
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s because banks, credit unions, insurance companies and other financial institutions are prohibited from even acknowledging the existence of an account due to privacy laws. Even if his mother had an account
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
with my firm, I wouldn’t have been able to tell him.
Brian and his siblings will have to hire an attorney and go before a court so that one of them can be appointed the executor of her estate and receive t
Brian and his siblings will have to hire an attorney and go before a court so that one of them can be appointed the executor of her estate and receive t
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
e legal authority to get information on her accounts, pay her bills using her funds and begin the process of settling her estate. Of course, all that takes time.
If a Will is never found it will be up to t
If a Will is never found it will be up to t
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
he courts to decide how her estate is divided. Each state has its own laws regarding what is referred to as intestate succession. Her assets may end up not going to the people she wanted them to. For instan
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
e, if she was separated from her husband (but not divorced), he could end up getting 40% of everything, even though she may have wanted it all to go to her children.
Some assets may never be found. What if
Some assets may never be found. What if
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
his mother hid money or other valuables in a secret place in the house? In fact, did you know that it’s estimated that 30% of U. S. Savings Bonds are never redeemed, largely due to them never being found?
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
t could be a year or longer before this estate gets settled. Thousands of dollars will be needlessly spent. And it could have all been easily avoided.
The moral of Brian’s story is that no matter how young
The moral of Brian’s story is that no matter how young
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
you are, you need to have your affairs in order. You need Powers of Attorney, a Will and maybe a Living Trust. You need to let someone know your wishes and where these documents can be found. It’s not just
.
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
the right thing to do, it’s your duty. It’s also an act of love to your family.
Mr. Voudrie is a Certified Financial Planner, a nationally syndicated columnist and the President of Legacy Planning Group, I
Mr. Voudrie is a Certified Financial Planner, a nationally syndicated columnist and the President of Legacy Planning Group, I
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
c., a Private Wealth Management firm in Johnson City, TN. He can be reached by email at jeff@guardingyourwealth.com or by going to www.guardingyourwealth.com
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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