Advice You - Business

Disclosure laws in franchising are suppose to help the consumer. They don’t. The FTC, which over sees franchising has in fact created a rule, which makes 5 lb. Disclosure documents for franchise buyers, which is so huge that no one

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

ever reads it. I know when I personally meet a franchise buyer whose application form is approved and hand them a UFOC, Uniform Franchise Offering Circular with attachments and watch their jaw drop and then their hand drop when they

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

Examples of combination products may in

clutch it in their hands (due to the weight of the 155 to 200 pages), I see a blank look. I apologize every time for my unreasonable government and the US legal system for the rules.

I tell them it is to protect them and put up my

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

shoulders and they usually say something like “Yah Right.” A franchise buyer who wants to buy a franchise is not going to read and expect to understand every clause, nor are most franchisors going to enforce every clause. You can’

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

, you would not have any franchisees left. There are too many laws in franchising and too much regulation. Many times a franchise buyer will ask me, “What the hell does this have to do with washing cars?” I really cannot answer wh

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

Combination pro

t I really think, I would launch into a tirade that would last four hours full of more examples than I care to write in this brief letter. I could write a book over disclosure and franchise law.

The fact is that we are a mobile ca

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

r wash franchise for the most part and that is a relatively easy and simple business. As much as the professionals care to argue to the contrary, all these disclosure laws just are not needed. Neither is all this regulation and sur

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

ly not anymore than already exists. You can sit and argue why the rules and all the laws are necessary, but you will never convince myself or franchise buyer of it. Has anyone stepped away from the box long enough to see how absur

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

d this is? Are we all so engulfed in the words of the statues and rules that we cannot see what we are doing. Forcing some businesses into the franchising model that should not be there, forcing the square peg where it does not fi

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

.

Half the time it appears we have lost site of the peg and it has found itself in a place where the sun don’t shine. Thank you for keeping it safe for us, but really the FTC does not need to go that far. There are enough rules,

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

nd rules about rules and findings about rules, and opinions about rules. We should tread lightly, before we make more rules. We should look at all the consequences of the rules we make and try to find fault with the rules we alrea

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

Following aspects would a

dy have. The FTC can spend time debating which rules to axe rather than which rules to enact. This will definitely keep them busy, and it puts them in the distinct position of being part of the solution instead of the problem.

Th

dd to the challenges in developing combination products:

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

consumer does not really want any more barriers to buying a franchise. They do not like the 10-day waiting period, which ends up half a month with holidays. They do not want to go through a long sales process. They want instant

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

gratification and they want to start their new career/business and embark on their new chosen lifestyle. All these regulations have complicated the issue and made it tougher to buy franchises, all to the frustration of the consumer

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

Tell me did anyone ever take a survey of the sales process and large documents of existing franchisees and ask them what they think of the whole mess, which has been created to supposedly help them? NO, of course not. Yet, I can

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

ot think of a franchisor, which does not constantly survey their end users of the franchised outlet for the desires and events leading to a sale of goods or services and on all those surveys they always ask the same things. Did you

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

Professional from academic institutions, pharmaceutical industries, health care indust

feel that all your questions were answered, were you happy with the buying process, were your needs met, etc.?

Why doesn’t the FTC ask real franchise owners what they think of all the paperwork, large documents and rules. Simply

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

aking the information from lobbyist groups of franchisee advocate rabble-rousers will not do it. Taking Internet complaints will not do it. Ask the actual franchisees already in the systems, the good franchisees, which follow the

.

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

system. By making more rules the FTC is actually hurting the franchisees, lengthening the documents. This causes new case law, more stipulations and boiler-plate phrases all adding to the length and complexity of the documents, ag

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

Companies that provide selfless information through particip

eements and buying process. Thus causing another law or rule to follow after circumstances unanticipated show their heads over issues of previous rules. And would you look at all this has created now? Whheeewwweee? Think about it

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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