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  • Drug Makers in the Healthcare Reform Catbird Seat [View article]
    I don't think that a promise of reduced approval cycles would be sufficient to sway the medical device manufacturers. They are always aware that they are one election and one major device failure, like the knee replacements 10 years ago, from having cycles stretched out again.
    I think the concession the are really after is more patent protection, although that's less of an issue in the device market than it is in the drug market. Still, patent extensions, or easier-to-get modification approvals, are much less likely to be overturned once put in place.


    On Sep 26 08:32 AM Mikethelad wrote:

    > Firstly, maybe Advamed isn't being as effective as the other lobbying
    > groups for pharma and services.
    > But, the quid pro quo for device companies for a hefty fee like the
    > one above could be an acceleration in new product registration cycle
    > time from the FDA. Comparing the US with European regulatory time
    > to approval, new products come to market in the EU 15-24 months in
    > advance of the US.
    Sep 28 10:52 am |Rating: 0 0
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