Advice Pool - Legal

Have you ever noticed that a television ad for your favorite hamburger, at your f

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

avorite fast food restaurants had a disclaimer at the end of the commercial, whic

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

Examples of combination products may in

said; available only a participating dealers? And then you think to yourself 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.

my local franchise outlet participating or not. In other words can I get my hamb

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

rger for 99 cents or will I get there in the price will be the regular $2.99 as u

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

Combination pro

ual.

These issues can hurt all the synergy that would normally be gained in 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

anchise system through economies of scale and mass advertising dollars. To allev

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

ate such problems in my franchise company and to prevent such things from hurting

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

our regional marketing campaigns on the radio and cable TV, I decided to address

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

his issue in the franchise agreements prior to the commencement of the franchise

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

utlet. Below is the clause regarding pricing, which I put into our franchise agr

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

Following aspects would a

eements;

3.15 Pricing

Franchisee may determine the prices at which Franchisee s

dd to the challenges in developing combination products:

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

lls the products and Services, as well as the terms and conditions of sale for

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

uch products and Services. Franchisor may from time to time suggest prices to F

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

anchisee for the sale of The Car Wash Guys products and Services, but the Franchi

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

ee will not be required at any time to sell at or above such suggested prices.

-

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

You see, consistency is one of the major ad

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

antages of franchise systems in the eyes of the consumer and you must protect thi

.

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

advantage to help you or franchisees succeed in the marketplace. You would be w

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

Companies that provide selfless information through particip

ll advised to discuss this with a franchise attorney and to 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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Advice Pool - Franchising Agreements and Pricing Issues

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