Advice You - Business

Free enterprise is where buyers and sellers of their own free will come together in trade thro

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

ugh a common monetary instrument. Regulatory bodies such as the Federal Trade Commission are c

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

Examples of combination products may in

ompletely oblivious to free markets and free enterprise whenb it comes to franchising. If a fr

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

anchisor is forced to offer or send out information of an offer to a “prospective buyer” that

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 is unsure that he even wants to do business with, then in fact it is not free enterprise. I

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

Combination pro

t is forced enterprise. When Government is forcing one party against their will to do busines

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

s with another party whom they are not sure about, that is not free enterprise, actually it is

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

not even close.

Franchising is not a toy at one of the remaining mall location Toys R Us stor

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

es sitting on a shelf where anyone can walk in and view it and the price is set. This is fran

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

chising and it consists of many other issues. It is an ongoing relationship, which might span

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

20 or more years. You would not marry a person or propose a marriage until you felt you knew

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

Following aspects would a

the person better. Franchising has been described as a marriage by many organizations such as

dd to the challenges in developing combination products:

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

the SBA, SBDC, FTC, IFA, AAFD, Women in Franchising, AFA, NFC and others. In college textboo

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

ks I have often seen the statement comparing Franchising to a marriage.

The late great “Dave”

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

founder of Wendy’s in his book describes it as a marriage. It is also in other books I have r

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

ead. When giving speeches at colleges to business students I have used this analogy and never

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

Professional from academic institutions, pharmaceutical industries, health care indust

once has the professor pulled me aside afterwards to discuss such a comment. It is a common

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

nalogy and it fits and we should treat it as such. Forced enterprise is very socialistic in n

.

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

ature and would not fit into the current structure of capitalism. Forced marriages do not exi

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

Companies that provide selfless information through particip

st to any large degree in America and neither should forced franchised outlets. Think about it

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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