Main Subject - Business

In the past many business opportunity sellers would use industry specific statistics on their Web sites, brochures and even in videos, which they would mail to

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

potential buyers. The Federal Trade Commission looked into this and found that many business opportunity sellers overused these figures to sell their wares.

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

Examples of combination products may in

In the future this tactic of using industry statistics may become illegal and considered fraudulent due to a proposed rule that the Federal Trade Commission is

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

considering which would govern business opportunities. In the rule business opportunity sellers would have to prove and have records to prove that the statis

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

ics they use are actual statistics of people who bought their particular business opportunity.

Why is such a rule being considered by the Federal Trade Commis

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

Combination pro

ion? Well, because there has been fraud in the past uniform of unsubstantiated earnings claims, which has damaged consumers. Below is an excerpt from the rul

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

emaking section report by the Federal Trade Commission on their potential proposed rule;

Proposed section 437.4(c): Industry statistics

“As noted above, prop

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

sed section 437.4(c) would address a problem that is prevalent among business opportunity sellers: the use of real or purported industry statistics in the mark

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

eting of business opportunity ventures. It is common for vending machine promoters, for example, to tout what are purported to be industry-wide vending sales s

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

atistics. A matrix of potential earnings based upon an industry-average sliding scale of “vends per day” is typical. The use of such industry statistics in the

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

promotion of a business opportunity creates the impression that the level of sales or earnings is typical in the industry, and by extrapolation, that the prosp

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

Following aspects would a

ective purchaser will achieve similar results.

To prevent this type of deceptive earnings claim, proposed section 437.4(c) would prohibit the use of industry

dd to the challenges in developing combination products:

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

inancial, earnings, or performance information “unless the seller has written substantiation demonstrating that the information reflects the typical or ordinar

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

y financial, earnings, or performance experience of purchasers of the business opportunity being offered for sale.” Accordingly, before a seller could use indu

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

try statistics, it must be able to measure the performance of existing purchasers and document that the industry statistics reflect the existing purchasers’ ty

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

ical performance. For example, a start-up business opportunity with no or very limited prior sales would probably not be able to use industry statistics becaus

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

Professional from academic institutions, pharmaceutical industries, health care indust

e it would lack a sufficient basis to demonstrate that the industry statistics reflect the typical or ordinary experience of the start-up’s prior purchasers.”

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

If you are a business opportunity seller perhaps you may wish to contact the Federal Trade Commission on this proposed rule and putt in your own comments. For

.

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

instance you might state do you think the rule is unfair or that it needs to be slightly modified or to be made fair. Perhaps you believe that legitimate indus

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

Companies that provide selfless information through particip

ry associations, which put together data and reports should be allowed. But it is time now for you to speak or forever hold your peace. Consider this and 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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It's a well-known fact that it costs many times more to acquire a new customer than to keep doing business with your existing ones. For this reason, the best way to become profitable is to have loyal customers who keep coming back again and again. It's all about relationship building. So what can you do?

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