Main Subject - Business

Many practitioners of business opportunities, which sell small business models to consum

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

ers, are excited to see that they will soon have a separate category of law, rules and r

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

Examples of combination products may in

gulations at the Federal Trade Commission. Most all Franchisors, those who sell franchis

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

s are also ecstatic over the move and say it is about time.

Here is an excerpt from the

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

Federal Trade Commission’s report of all the commenters on this proposed rule change and

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

Combination pro

separation of the two business models;

“Based upon its enforcement experience and the

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

ecord developed to date, the Commission has determined to promulgate a separate trade re

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

ulation rule to address widespread fraud in the sale of business opportunities. This app

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

oach is consistent with the view of the vast majority of commenters and the regulatory 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

pproaches adopted in most states.”

“Further, unlike most franchises, many business oppo

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

tunities are permeated with fraud. Perhaps one business opportunity and franchise consul

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

Following aspects would a

ant said it best when she described many business opportunity sellers as:

Individuals w

dd to the challenges in developing combination products:

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

o go from one business opportunity to the next, violating laws, committing frauds, takin

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

g funds without delivering what was promised only to shut down the operation within a ye

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

r and move on to another one with new officers, new company names, and new products.”

N

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

w some Franchisor founders are saying; “what on Earth took the FTC so long to figure thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

out?” after all they have been told this for years? It really is about time. What will

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

this mean for Biz Ops? Simpler rules and regulations from the FTC and easier to understa

.

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

d disclosures for customers and for Franchisors it puts up a barrier, which prevents the

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

Companies that provide selfless information through particip

mixing of laws between the two very different business models. Consider all this in 2006

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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