Main Subject - Business

If you are a small businessperson then chances are you have had a situation occur where another small business or larger competitor has used the local Government code

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

enforcement officer to harass you. This is a common occurrence and it is unfortunate that they do not teach this at the SBA seminars.

The good old boy network that o

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

Examples of combination products may in

curs in most cities is alive and well in the United States of America. This occurs both in large cities and small towns. Competitors know that if they can get the lo

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

al code enforcement officer to come over and find a violation in your business that it will slow your business town and therefore give them the edge.

It is too bad th

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

t people do not have more integrity than that and too bad it competitors call in competing companies for violations. Of course if you are violating the law he should

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

Combination pro

ot be violating the law, but we know that many of the rules and regulations from the municipal level all the way to the federal level are quite onerous and this is unf

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

ortunate.

It is literally impossible to follow all the rules or for that matter even know all the rules. In my 27 years in business as a Franchisor, I cannot tell yo

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

how many times our franchisees just starting out in their local areas had to deal with competitors who called them into the code enforcement. Often they had done not

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

ing wrong; except step on the toes of an existing businessperson, which was well-connected in the city.

Sometimes, a smart code enforcement officer will realize that

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

he complaint coming in is from a competitor and simply make a visitation to the company or business involved in the complaint. This is an opportunity for you as a sma

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

l businessperson to talk to the code enforcement officer and ask them if they can help you comply with all the rules.

This way they will explain what the rules are an

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

Following aspects would a

d which rules they are most apt to care about. Being on a first name basis with the code enforcement officer in a local municipality is a smart thing to do for any bu

dd to the challenges in developing combination products:

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

inessperson.

It is extremely important for you to realize that these things happen and although it may be personal between you and your competition; it is not persona

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

between your company and the code enforcement officer. If you are breaking the law he will have to comply with the law and it behooves you to learn exactly what the

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

aw is and the intent so that you can remedy the situation without further problems from the code enforcement officer.

When a competitor makes a false complaint they a

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

tually end up hurting themselves and therefore it is unwise to turning your competitors unless they are ripping off customers, polluting the environment or doing somet

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

Professional from academic institutions, pharmaceutical industries, health care indust

hing that you know to be harmful to others.

Simply turning in your competitors for a minor violation or infraction will only cause you to have a war with that competi

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

or and just imagine all the different regulatory bodies that there are in our government and what you will do if each one of them comes to visit you during a one month

.

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

period.

In fact it will be impossible for you to get any work done or make any money. So before you go in turning your competitors remember the Golden rule. Oh and

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

Companies that provide selfless information through particip

ne last thing; if a competitor turns you in for something that means they consider you a threat and that means you must be doing something right. 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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