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    Public administration is a subject of human inquiry with ancient roots. Contrary to present practice, the ancients were preoccupied with governance of public affairs as opposed to business, and very often, as in Greece, had disdain for commerce and management of business enterprise. Ancient empires created elaborate sta
    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
    te structures, and effectively operated an apparatus overseeing huge territories. China gave the world the first civil service system some two thousand years ago, while the Roman Empire set the structures of governance (e.g., the organization of the executive branch into five main agencies) that many modern European sta
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    es borrowed in their development.(1)

    Management Models of Public Organizations

    In the first direction, management of public organizations, two basic models can be recognized: a) the classic administrative model (from Taylor, Wilson and Weber to Simon and March); and b) the human relations model (from Mayo and Follett
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    to Golembiewski and Argyris).

    The second direction, bureaucracy in the framework of constitutional democracy, ismore diverse because of its close bonds to the fields of political science, economics and sociology, as well as its larger scope (society at large). Larry Hill, (2) for instance, classifies theories of bureau
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    racy according to the end result-the impact they prescribe to bureaucracy in governance. This classification has three main categories or theories: (1) bureaucracies are (or should be) weak and instrumental; (2) they are significant actors in political process; and(3) they dominate the policy process.

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

    Combination pro
    ic Administration

    David Osborne and Ted Gaebler’s Reinventing Government (3) is the most popular paradigm of public administration in the 1990s. It produced a popular agenda for high performance government, an agenda which Vice-President Albert Gore and the National Performance Review (4) adopted in Creating a Governme
    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
    t that Works Better and Costs Less. Their recommendations for process and service improvements may have greater impact than those contained in a dozen or so comparable efforts over the last century. Perhaps government has never been under such pressure from the public to be more productive and effective; nor has governm
    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
    nt appeared more willing to change. The ‘‘reinventing government’’ paradigm is a rather eclectic synthesis of different approaches. It has ten tenets:

    1. Government should act as a catalyst—it should ‘‘steer,’’ rather than ‘‘row.’’
    2. Government should empower rather than serve.
    3. Government should be comp
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    titive.
    4. Government should be mission-driven rather than rule-driven.
    5. Government should be result-oriented, and should not base its actions on inputs.
    6. Government should be customer driven.
    7. Government should be enterprising.
    8. Government should anticipate rather than cure social ills.
    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

    9. Government should be decentralized.
    10. Government should be market-oriented.(5)


    Goals of Public Administration

    Of the two central goals of public administration,(6) first maintenance and then task. The first goal emphasizes the development of a sense of ‘‘inside’’ and ‘‘outside.’’ This requires iden
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ifying the analytical ‘‘us’’ as contrasted with ‘‘them,’’ as well as specifying the character and quality of the relationships between the ‘‘us’’ and the heterogeneous ‘‘them.’’

    The second central goal emphasizes comprehending what’s going on in management—the development of tools and skills for description, analysis,
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nd action. The first goal may be labeled ‘‘maintenance,’’ and the second ‘‘task.’’ The key questions associated with the first goal are:

    • Who am I professionally and, to at least some degree, who am I as a person?
    • Whom do I associate with in seeking and applying knowledge?
    • With what scholarly discipline(
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ) or field(s) do I identify?


    The key questions associated with the second goal are:

    • What is my legitimate domain for study?
    • What concepts or tools should I use?
    • What are my criteria of reality or truth?
    • What are the broad goals or values that my contributions to knowledge or truth should ser
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ve?


    PUBLIC ADMINISTRATION IN THE SERVICE OF DEMOCRACY

    From Reinhold Niebuhr’s classic volume, Moral Man and Immoral Society, we are informed that ‘‘Practically every moral theory, whether utilitarian or intuitional, insists on the goodness of benevolence, justice, kindness, and unselfishness.’’ During the periods
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    f no national ethical unity, it is generally inevitable that the career public service is the first to be affected adversely by the external and internal centrifugal forces of suspicion, distrust, and cynicism.

    A heavy burden rests on the career public service to assume the initiative in creating among the body politic
    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
    the new possibilities for igniting the centripetal forces of ethical values and moral virtues.

    In a word, society is dependent on the career professionals in governments at all levels to lead it to a new value vision of the common good. As a first step in this direction, public administrators must be willing to confron
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    the suppressive and debilitating constraints, which currently are being imposed on ‘‘bureaucracy’’ from all directions, and to reaffirm the values and virtues inherent in the notion of service, which have unified the ethical forces of democracy so well in the past.

    References:

    1. See, for example, Wren, Daniel A. The
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Evolution of Management Thought, 4 ed., Wiley, New York, 1994;Heady, Ferrel. Public Administration: A Comparative Perspective, 5th ed., Marcel Dekker, New York,1996.


    2. Hill, Larry B. ‘‘Who Governs the American Administrative State? A Bureaucratic-Centered Image of Government.’’Journal of Public Administration Res
    .

    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
    arch and Theory 1 (July 1991): 261-294.


    3. Osborne, David, Gaebler, Ted . Reinventing Government: How the Entrepreneurial Spirit is Transforming the Public Sector, Addison-Wesley, Reading, Massachusetts, 1992.


    4. National Performance Review, Washington, September 1993.


    5. Osborne, David and Gaebler, Ted.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    einventing Government: How the Entrepreneurial Spirit is Transforming the Public Sector, Addison-Wesley, Reading, 1992.


    6. The immediate argument closely follows Robert T. Golembiewski. ‘‘‘Maintenance’ and ‘Task’ as Central Challenges in Public Administration.’’ Public Administration Review 32 (March 1974): 168-169


    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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