Advice You - Business

There are so many naturally occurring business situations, which cannot be properly fit into the UFOC or Uniform Franchise Offe

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

ring Circular for proper and legal disclosure to new franchise buyers as per the onerous rules and regulations in the Franchisi

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

Examples of combination products may in

ng Industry. You would think that a 250-page franchise agreement would be all encompassing, but it is not always. Often there a

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

e times when the rules and regulations do not consider other than straight black and white franchise sales. Such as transfers,

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

trades, vendor deals, family members, original franchisee discounts to get the ball rolling.

Recently, I was discussing all th

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

Combination pro

s with an individual who unfortunately had their franchise fail. His comment was that in the UFOC it showed a lawsuit with a fr

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

anchisee and then that franchisee’s name was not listed in the exhibit section. The franchisee in the lawsuit was apparently te

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

rminated, which makes sense right? And then that franchisee was run by a family member of the Franchisor; Why you ask? Well sim

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

le, the Franchisor did not wish to have a closed store or brand name loss and the family member wanted to run the outlet, makes

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

sense right?

Sure, but consider the problems now with the franchise documentation and proper disclosure. You must understand

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

hat Franchisors are required by law to make changes as they occur in the franchise documents. If the founder's family member to

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

Following aspects would a

ok over an abandoned franchise so the franchisor would not lose brand name due to an empty failed store in the beginning then t

dd to the challenges in developing combination products:

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

here is nothing wrong with that business decision to do that. It is not deception to change the data, it is the law to upgrade

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

t every 6-months.

The lawsuit is disclosed as is required by law. Sometimes when a transfer is made the new store owner change

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

s the list of franchise owners. In the case of a terminated franchisee for cause or abandoned franchisee this would trigger a c

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

ange in the list of franchisees in the back regardless. That is a very weak case unless the franchisee complaining about it bou

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

Professional from academic institutions, pharmaceutical industries, health care indust

ght their franchise prior to the date when the change was made, but never the less it was listed in the section of litigation,

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

which is proper.

So, often onerous rules and regulations miss things like this because the people making the rules assume ever

.

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

franchise deal is cut and dry. It is not and to that point these types of issues should be considered. What is the answer to a

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

Companies that provide selfless information through particip

ll this you ask? Well, reduce all the rules require no disclosure and thus no problem is created you see? Consider 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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