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    A Maryland State Legislator proposed a bill last year to further regulate franchises in their state. As we allow states to dream up more laws we become th
    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
    e United Countries. Luckily the Maryland Lawyer did not get her bill past, but she might have? It is sickening to see folks make laws who have never had t
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    o earn a real living or make a payroll. They are stifling our country. Franchising does not need any more laws and Maryland does not need anymore lawyers.
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    Here is an excerpt of a letter admonishing the lawmaker, who introduced the bill for increased franchise regulations:

    “The US system of government is se
    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 up like a franchise system and follows the same principles as the franchising model. I hope you understand how much franchising gives to the communities
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    it serves in good will, assistance and God forbid disaster; we are there for you and every single citizen rain or shine. Think about it.

    That is what 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
    anchising is really about. We are in a recession many franchise stores have failed, the percentage of small business that failed is much higher, because f
    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
    anchisees have a superior system of business. Please read; Michael Gerber's "E-Myth" if you have not already. Franchising is good for consumers, consumer
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    choice and fair pricing to consumers. This Bill of Mary Ann's might have good intentions, however realize that auditing franchisees every year causes a ri
    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
    ft in the franchisee and franchisor relationship, just like the IRS Audits cause tension with citizens and cause a rift of mistrust in government. Auditin
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    g costs lots of money of which someone has to pay in higher pricing. If the franchisee pays then the franchisee has been put at a disadvantage in the mark
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    et place because he has to pass that on to the consumer. Thus the consumer pays higher prices, that in it self is a tax on society over all.

    I thought we
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    were trying to lower taxes for America, single moms and all my associates and good friends at the AARP. If the franchisor pays he passes it on to the fra
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    nchisees and the franchisee therefore has a slower ROI to feed his family, buy soccer shoes and send them to the proper schools so they can get a law degr
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e and grow up just like you. Hopefully those young men and women our future would not dare think of putting up more barriers to entry into free markets or
    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
    using little very little brain capacity that is required for such linear thinking in this Bill. We as a Nation are generally destroying free enterprise a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    s we know it, but why in Maryland? I thought we in Maryland were smarter than that? Are you trying to protect consumers? This will not work, if you want a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    stronger small business sector, then by God open up the flood gates and get rid of all the current franchise registration in Maryland it is redundant of
    .

    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
    Federal Law. “

    - - -

    Entrepreneurs should not have to write such letters to politicians there is work to do in the market place and brain dead asinine p
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    oliticians, lawyers and lawmakers in states like Merry Land ought to catch a clue and understand who the real world works. Everyone needs to think on this


    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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