Advice You - Business

Often in franchising companies a franchisor will spend 80 percent of their time helping 20 perce

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

nt of their franchises. The allocation of the franchisor’s labor will be disproportionate and i

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

Examples of combination products may in

n effect on fair to the superstar performing franchise outlets in the franchising system. There

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

are also times when a franchisee will have needs that our way beyond the call of duty and those

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

requirements of the franchisor in the franchising agreement.

It is for this reason, especially

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

Combination pro

with our international franchises that I decided to add a clause into our franchise agreements,

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

which protected our cash flow and time management all of our consultants, employees and staff.

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

Below is a copy of the clause that I put into our franchising agreements;

4.4 Advisory Service

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

s

Franchisor may provide, as and to the extent required in Franchisor’s judgement, a continuing

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

advisory service, which may include consultation on promotional, marketing and advertising tech

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

niques and customer relations. Representatives of Franchisor may consult regularly with Franchis

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

Following aspects would a

ee at no cost to the Franchisee. At Franchisee’s request, a representative of Franchisor may vis

dd to the challenges in developing combination products:

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

it the Franchised Business at least once each year at a time mutually agreed upon. Field represe

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

ntatives may be available at Franchisee’s request for extraordinary consultation and assistance

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

on a fee basis by appointment only. Franchisor’s current fee for extraordinary assistance is U.S

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

$250 per day, plus all related expenses and may be increased by Franchisor.

-- -- --- --- ---

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

Professional from academic institutions, pharmaceutical industries, health care indust

--- -- --

It may be necessary for franchisors to address such issues in their franchising agree

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

ments, prior to running up against the problem or potential eventuality. It is recommended ther

.

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

efore that every franchising company contact their franchise attorney and discuss this issue. I

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

Companies that provide selfless information through particip

hope if you are in franchising you can learn from my school hard knocks. 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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