Top Adding - Insurance

I am not superstitious nor do I have many idiosyncrasies about death. I know a lot of people do, but not withstanding, I don't give a hoot about what happens with my body at that stage. I whol

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

eheartedly subscribe to cremation and I am a registered organ donor, so take what you will before I become combustible. This leads me to my story concerning a minister who founded a church on t

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

Examples of combination products may in

he South Side of Chicago in the late ‘30s. He must have been a persistent sort because he stayed with it and experienced the growth of his congregation by leaps and bounds. He passed away in th

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

late ‘70s. The church had grown, but wasn’t prosperous enough to build a monument to him. It was the height of ridiculousness that he was buried in a segregated cemetery. The church congregat

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

ion continued to grow with his successor. After twenty-some odd years after his death, they were able to move him to an “equal opportunity cemetery”, which would not accept him right after he d

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

Combination pro

ed. Given the location of this holy ground, one would have a hard time believing they would not accept his remains back then. A real travesty in my mind, because we are all created equal. Even

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

before they dug him up, they had started construction in a mausoleum to honor his life and work.

I’m not sure what they expected after twenty plus years, but when he was unearthed he was a li

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

tle soggy. The burial vault sprung a leak. His face and head were pretty much gone, but his white suit was primarily in tact. I have the photos in my file. The funeral director and church hiera

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

rchy were aghast. They brought suit against the vault manufacturer but not right away. Being the insurance rep for the carrier that insured the vault manufacturer, I got a real blistering earfu

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

from the current pastor. The funeral director was pretty upset too. By the way, they did move him to his new surroundings and had quite a ceremony within spitting distance of the mausoleum the

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

y had constructed. The church felt cheated because of his decayed state. The funeral director said he would lose business because his future clients were very upset. He explained that his condi

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

Following aspects would a

tion upon being unearthed put them under a bad sign. Some might use the word spooked. The hierarchy of the church felt they might lose patrons because of this shameful situation.

They eventua

dd to the challenges in developing combination products:

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

ly filed suit, but before they did, they made a demand of $60,000 for the church and $100,000 for the funeral home. There were two strong considerations mitigating against them. Illinois law pr

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

ovides no protection, rights, or status for remains. The burial vault had a warranty that provided for the replacement of the vault with a similar one, and nothing more. There also was a quest

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

on of coverage for a variety of reasons. When did the vault fail? The vault was sold in the late '70s and no manufacturer can be held accountable for a defective product after 20 years.

The c

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

ase was denied in writing to the church and the funeral director. The case was eventually dismissed by a judge through a directed verdict.

When I was out interviewing the funeral director and

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

Professional from academic institutions, pharmaceutical industries, health care indust

the pastor, they did their best to intimidate me with no appreciable success. I had a pretty good idea before I went out to interview them that the case was going to be denied. However, the car

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

rier wanted the whole story before making their final determination about the merits of the case. I let them blow off steam and it seemed to me they were getting a lot off their chests. In retr

.

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

spect ,I believe they had an idea their gambit wasn’t going to be successful, but they persisted anyway. I always say, “Nothing ventured, nothing gained.” By filing suit I think they were hopin

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

Companies that provide selfless information through particip

g to get a nuisance settlement, which would have been a fraction of what they were asking. The way I heard them tell this lurid account of anguish would suggest that hyperbole is alive and well

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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