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Useful Articles - Beware Industry Association Leaders Who Act Like Bureaucrats
If you own a small or medium sized business and you believe that by joining an industry association they will some ho
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
w help you, then you might be rather upset in the future to learn that your association acts more like a bureaucracy
; 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
than an actual business operation. Some say that organizations and associations act like bureaucracies in order to de
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
al with the government bureaucracies better. This might be so but;
Anyone who thinks that an Industry Association so
Anyone who thinks that an Industry Association so
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
mehow helps the little guy, well they simply do not understand how all this really works. First thing you need to kno
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
w is who is funding the association? Who are its members and who is paying its bills? If you have service vendors to
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 industry paying its bills then you need to be very careful, because these companies make money off the regulation
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
in place. Parasite companies if you will - Insurance, leasing companies, on-going education firms and lawyers.
As a
As a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
case study, let's take a look at a Trucking Association for instance and specifically let's look at the Illinois Tru
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
cking Association and their various Premium and Gold Star Members. We find insurance agents, publishers of regulatory
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
compliance materials and firms that make money helping members deal with regulations from government. But if the ass
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
ociation is so strong why are all these regulations even there?
Simple really, you see the associations help the big
Simple really, you see the associations help the big
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
ger players, larger companies and they actually lobby to put into place restrictive measures to slow the fast moving
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
smaller entrepreneurial competitors. In reality this makes the bigger companies weak and weakens the entire industry
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
nd hurts the consumers, but that is another story. Today we are talking about Industry Associations.
Industry Associ
Industry Associ
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
ations which operate in this fashion are controlled by the bigger fish, who wish to retain control and in doing so ne
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
ed information from smaller fish, or entrepreneurial companies, thus anything a smaller company does within an indust
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ry association often benefits the bigger companies and the Machiavellian Leadership of that organization.
For instan
For instan
.
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
ce no independent Trucker ever got rich by joining a Trucking Association, chances are they were run off the road on
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
the way to their reward for their many years of hard work. Not asking for anything more than for you to think on this
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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