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Useful Advices - Be Careful What You Wish For When Having a Large Benefactor is Not a Good Thing
You spend so much time and resources chasing too many small donors and too few large donors that sometimes you can't help but wish your organizat
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
ion had one large benefactor. While that could be wonderful, you ought to be careful what you wish for, because sometimes having a single large b
; 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
enefactor can hurt your organization more than it can help it.
There are the obvious problems with having one or two large donors: the organizat
There are the obvious problems with having one or two large donors: the organizat
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
on may have to placate a large ego to get the money, and the organization may have to contend with unwarranted interference by the donor in gover
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nance or program activities. Placating a donor's ego is often not so difficult to deal with, name something after the donor and all's well. Howev
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
er, if a large donor wants greater recognition, a special event in her honor for example, that could be headache. Donor interference is a little
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
it more difficult to deal with, but, hopefully, this situation is kept rare by crack administrative and development teams.
A less obvious, but p
A less obvious, but p
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
otentially more serious problem with having one or two large donors is the possible tax consequences. When the I.R.S. grants most organizations t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ax exempt recognition, it does so on the condition that those organizations gather most of their donations from the "public", by which it means a
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
broad spectrum of sources. A new organization has five years to get up to par in this area, and after that, the I.R.S. checks to make sure that d
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
onations are coming from the public. Ideally, the donations will come from a mix of direct donations, grants, program fees, and sometimes they co
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
me from tax dollars. If the donations are not public, then the I.R.S. will strip the organization of its tax exempt status. (This can happen to a
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
l organizations, not just new ones).
There are organizations that do not have to collect their donations from the public, but, usually, those or
There are organizations that do not have to collect their donations from the public, but, usually, those or
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
ganizations do not receive the same tax exempt status as public charities (one of the few tax classifications that is completely tax exempt). Gen
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
erally, if your organization fails to have tax exempt status because it has too few donors, then it will be classified by the IRS as a private fo
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
ndation. A private foundation is not completely tax exempt. Thus, if your organization has one or even just a few large donors it may have to pay
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
income and excise taxes.
On the other hand, private foundations are often set up in conjunction with public charities to get around just this p
On the other hand, private foundations are often set up in conjunction with public charities to get around just this p
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
roblem. A public charity can be supported by a private foundation that is funded by one donor or a few. The charity still must fundraise in other
.
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
ways, but there is much less of a chance of jeopardizing the organization's tax exempt status. This is a sophisticated planning tool usually used
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
by larger, more established organizations, but if you are seeking or already have a large benefactor, this is an excellent strategy to look into
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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