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    Traveling over the holidays to visit family outside of Denver, we were fortunate to arrive after a blizzard stranded thousands at the airp
    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
    ort, and depart before the cancellation of flights for a second storm. However, our holiday presents were not as fortunate. Okay, things h
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    appen.

    Following up on the undelivered gifts we were informed by a customer service representative, "Your packages are scheduled to arriv
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    on the 26th." No packages arrived on the 26th or the 27th or the 28th or the 29th ... you get the point. Yet each time we called back, w
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e were told they should be delivered tomorrow.

    Credibility could have been preserved if the carrier had simply told us the truth. Inundat
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    d with hundreds of thousands of displaced packages due to a two-day transportation shutdown, they had no idea when our particular packages
    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
    would be delivered. Instead, they did what many people do. They chose weasel words to evade, retreat and avoid commitment. They told us w
    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
    at they thought we wanted to hear.

    Like a weasel sucking out an egg's content without destroying the shell, weasel words give the appeara
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nce of communicating information as they suck out meaning. Words like many, much, should, maybe, often, some or seems can be put in that c
    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
    tegory. So can common workplace phrases like: "it has come to my attention;" "many people think;" "it has been decided;" or "we can deal w
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ith that later." It's easy to find them. Just listen for what is not being said and you'll spot the weasel words.

    These avoidance, non-co
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    mmittal spin words erode communication, trust and credibility. Of course, we all use them from time to time. But there's a difference when
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    we opt for their use to intentionally deceive. People who deliberately choose weasel words to deflect conflict, disagreement, obligation o
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    r accountability are not people who are winning at working.

    People who are winning at working know the power of words to build relationsh
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ps, influence results, and enhance trust. They also know their power to diminish credibility, motivation and results if they're used to cr
    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
    eate spin, deflect accountability or avoid commitment. Every word you use is a choice to build or diminish trust.

    While weasel words atte
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    pt to soften the impact of unpopular messages, especially in the workplace, in reality they build walls, diminish confidence, increase sus
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    picion, enhance rumors, and reduce results. Honest communication comes with risk, but so does dishonest communication, and those risks are
    .

    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
    greater.

    Just so you know, I won't be using that delivery carrier anytime soon. Not because the packages missed the mark, I can understan
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d that, but because their words did. Like Mark Twain said, "When in doubt, tell the truth."

    (c) 2007 Nan S. Russell. All rights reserved


    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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