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Recently the Maryland State Legislature thought it prudent to require more disclosure than is already required by law and a complete audit of each franchisee of every company, which was franchising in their state and providing jobs

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

and tax base. It is the typical thing dumb politicians do when they have no clue as to how free enterprise models work. There ought to be a test for all Maryland State legislators and lawyers on the reality of the market place. The

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

Examples of combination products may in

entrepreneurs cannot build as fast as the lawyers and bureaucracy is stealing from us. Caesar was right, maybe we should follow his thought process on this one. Here is an excerpt of a letter, I, an entrepreneur had to write the leg

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

islature to get that stupid bill killed in committee which was proposed by some moron politician there. Read it and think:

“. . .the competitive market will provide more jobs and the good franchisors through success will win the co

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

nsumers hearts and expand and the illegitimate ones will exit the market place. This Bill is similar to making a Law to prevent International Terrorism such as " It is allowed for anyone to fly an aircraft into a building." No kiddi

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

Combination pro

ng, that is already a law, but did that stop the International Terrorists? Franchise registration laws in Maryland duplicate The FTC little franchise acts anyway. The laws are already on the books and are hurting Maryland in so many

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

ways. More may kill it and certainly destroy the small business sector of which 68% of our population is employed, that's right and you thought the government employed everyone didn't you?

Have you ever tried to hire a CPA firm to

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

audit something? Let me tell you the cost in now a little over double that of a few years ago after 9-11. With Arthur Anderson exiting the market place there are fewer firms wanting to audit franchises. Errors and omissions insuranc

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

e are triple of prior years, fewer firms do audits, very few small firms even want the business anymore. Getting peer reviews for legitimate audits costs bundle too and since there are fewer because of over regulation in their accou

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

nting industry it takes twice as long to get your audits back meaning you may not be able to comply in the proper time frame for franchise renewal, thus you are dead in the water to open new businesses, franchise outlets, until they

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

are done.

If every franchisee had to be audited in your state of every system can you imagine how many audits that would be? Guess what, Maryland with as many accountants as they have does not even have enough to audit all the sto

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

Following aspects would a

res and there is now a shortage of competent auditors who have the proper insurance around and soon there will be even fewer. I want to know if Mary Ann (the introducer of this piece of legislation) has a husband, brother, sons, dau

dd to the challenges in developing combination products:

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

ghters which are CPAs, if so I believe I should scream bloody murder in all media outlets. I see something else here? Is it conflict of interest?

What is really behind this, this does not smell right; a Democrat against jobs? I hav

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

e nothing against Democrats and I presume they have nothing against small businesses, consumers or jobs? Then why attack small business (franchisees) are all small businesses? Why are you doing this. WHY?

Why are you trying to kick

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

Maryland in the butt in the middle of a recession, this really sounds like a terrorist type maneuver to me at least this is my opinion of this. Are you really planning on voting for this Bill? If this law is passed I, a franchisor,

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

will personally spend out of my personal monies to defeat those who voted for this Bill in the next election, but I will not give it to a person, We will do grass roots marketing in the strongest precincts of those who voted for thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s Bill, because I believe that strongly in America, her freedoms and free enterprise. We will go to the streets. We will work on the web, we will march, we will hold signs, buy bumper stickers and host Bingo Parties for as many AARP

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

members as we can find. We will hold free car washes fundraisers in support of opponents to this Bill, attach bumper stickers to patrons automobiles, we can and by God we will. . .”

- - - - - -

The Entrepreneurs of America are ge

.

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

tting pissed as the lawyers and politicians who are raping us make laws, which steal from the productivity of our nation. It is time for every American to remember how blood, sweat and tears built this country. It was the small busi

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

Companies that provide selfless information through particip

nesses and entrepreneurs, not a bunch of two-bit scoundrel lawyers turned politician. Our ancestors did not die for us to turn our lives over to a bunch of lawyers from Merry Land. I am fed up. You should be appalled. 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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