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Do franchise regulations from the government help protect the franchise buyer this has been

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

a big debate amongst franchising attorneys on both the Franchisor and the franchisee side of

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

Examples of combination products may in

the law. Further, 13 states have instituted franchise regulations and required registratio

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

n before a franchise or sells franchises to a resident in that state.

Other states have bec

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

me notification states and there are also a few of those, which require Franchisor's to send

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

Combination pro

in their disclosure documents or Uniform Franchise Offering Circulars UFOCs. But does all

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

this government oversight really help the consumer? The federal government at the Federal T

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

ade Commission also has rules, which govern those states which do not provide franchising ru

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

les of their own. They require that disclosure documents are given to each franchise buyer

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

10 days before purchase. Still, does all this protect the franchise buyer?

If you are cons

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

dering changing your career and perhaps owning a small business of your own such as a franch

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

Following aspects would a

ise then in this is important information for you. If the franchising company is in another

dd to the challenges in developing combination products:

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

state and selling you a franchise in a different state, then the franchise regulations in t

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

his state where the Franchisor is will not help you. Because State franchise regulation age

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

cies are in place to protect the consumers and residents of those states only.

If there is

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

a problem down the road with your franchise business and you attempt to complain to the fran

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

Professional from academic institutions, pharmaceutical industries, health care indust

chise registration Board in another state, you may be surprised that they are not interested

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

in your complaint and may even forward your complaint to the Franchisor's legal department.

.

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

Suffice it to say, if you are planning on buying a franchise business you need to be aware.

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

Companies that provide selfless information through particip

You need to ask lots of questions and use due diligence. Please 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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