Advice You - Business

The Federal Trade Commission has an obligation to the general public, their stated consumer education mission and to the over regulated fran

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

chising industry and the small business operators running Biz Ops to separate the two business models by way of legal definition. Any failur

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

Examples of combination products may in

e to completely separate them will trigger additional problems down the road and cause the current on-going process of rule review to contin

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

ue, without any formalization for decades.

This of course is good for attorneys who make money on these ambiguities for lawsuits and great

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

or Federal Trade Commission tenure and job security. A few also realize it could allow for additional travel budgets of governmental employe

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

Combination pro

es during these rule making processes on the taxpayers money. It would also trigger more time-out, “let’s think about this one”-coffee break

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 on various floors of the Federal Trade Commission’s fully furnished 1970 desk style ambiance. However it is not good for consumers or indu

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

stry and creates unleveled playing field on one hand and complex barriers to entry for start-up entrepreneurs with regional dominance and ef

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

iciencies, which lend them selves well to the franchise business model on the other. This is because Biz Op MLM salespeople are purporting t

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

hat they as similar to franchised business, by using terms like ‘Private Franchising’ in their presentation.

These MLM business sell in cof

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

fee shops and public presentations, which would send chills down the spine of any compliant franchising executive or real franchisor. So the

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

Following aspects would a

n, what is a real franchisor? What is private franchising? What is a Business Opportunity? What is an MLM business? What is a hybrid or c

dd to the challenges in developing combination products:

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

oss-breed of any of these combinations? How on Earth in laymen terms can the Federal Trade Commission explain this to us, so that we might

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

explain the differences to consumers when asked. Where on the Federal Trade Commission website is there a place which describes all of them

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

and the possible variations? Due to the introduction of the term “Private Franchising” in the interim between 1999 comments and 2004 evalu

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

ations of possible definition revisions by Federal Trade Commission it appears that the definition landscape in the real world is hyperspaci

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

Professional from academic institutions, pharmaceutical industries, health care indust

g the definitional upgrades to the franchise rule in the wonderful world of bureaucracy. We should not kid ourselves into thinking that the

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

latest FTC report or any subsequent changes now, will change anything in the actual market place as to the number of; non-existent fraud ev

.

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

ents in franchising. The number of fraud cases in franchising is basically nil as per Federal Trade Commission’s own statements to congress

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

Companies that provide selfless information through particip

. Yet the MLM crowd is manipulated truth by miss using the word franchising and that misrepresentation is damaging consumers. 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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