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  • Main Subject - Internet Tip of the Week: Cease and Desist

    While we all admit that unsolicited commercial email is a real pain, I sometimes wonder if the anti-spam zealots are going too far. Last week I was in Costa Rica, and the only
    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
    practical way to communicate home was by email. I maintain an AOL account just for that purpose when traveling, and was amazed to find out when I got home, that I only recei
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ved about half of the email which was sent - some of which was important.

    Many ISP's (Internet Service Providers) including AOL, have installed content filters which automati
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    cally relegate anything "they think" is spam to trash, and the message never gets delivered to the intended recipient, nor is the person sending it notified it wasn’t delivere
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    d.

    The problem is that there is no personal judgment at the level of the ISP to determine if a note is spam or not. They have installed content filters that "dump" any email
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    that happens to match the keywords they have installed. How dare they determine what I should receive or not receive. Because a word in the note (or the length of the note)
    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
    met their reject parameters, they will not deliver it? This is wrong!

    Shame on them! I don't know about you, but I don't want my ISP acting like "big brother" on my behalf,
    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
    nd determining what I should read and what I shouldn't.

    I do agree that spam is not only a nuisance, but is a daily problem that takes my time to sort through and get rid of
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the "junk" I didn't ask for, and don't want to get. But let me make that determination. I can set up filters that automatically deletes email I don't wish to get myself. I d
    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
    on't need, nor do I want someone else making that decision on my behalf.

    It has been reported to me that some ISPs are blocking newsletters that people have asked to receive.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Some investigation turned up that certain words were on their "banned" list and they appeared in the newsletter. Several of our publications include a medical column by Dr.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Earl Mindell. Will there be words in that column that match the filters these "self appointed guardians of email" have installed - Sure. Will the newsletters exceed some mag
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ical length they have determined to be spam - Right again. Is this spam - No! How about an email constructed in an HTML format? Some ISPs automatically delete anything witho
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ut text in the body of the email - wrong.

    Sending out spam is big business. The federal law enacted in the USA is ineffective as the major "spam houses" simply comply with t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ose guidelines. Some suggest that the domains of the spam houses be blocked. Get real! Domains are a dime a dozen. If one gets blocked they simply use another.

    But if someon
    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
    e makes a complaint about you, they may block your ISP. I know of an instance where an ISP blocked Comcast.net and nobody using that ISP could receive email sent by Comcast u
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    sers.

    The early days of the Internet, which was the sole property of the academicians where spam was anathema, are over. The Internet is ideally suited to support e-commerce,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    which it does very well. Online advertising is now a way of life.

    Now - don't feel I am supporting spam but for goodness sake, I don't want someone else monitoring my email
    .

    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
    and determining what I should read or not.

    How many legitimate emails do we have to "not get" because others are making that decision for us. How many requests for informat
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ion should get "blown away" because the reply violated some ISP's filters. My feeling is that they should cease and desist, and not be the self-appointed guardians of my inbox


    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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