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FDA slowdown in approvals

  1. I got this from the Motley Fool newsletter. It may have some bearing on SBP, BTA and the like.

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    After 18 months in office, President Bush has yet to appoint a commissioner to head the Food and Drug Administration (FDA). The drug industry has been pleading him to do so.

    The lack of a commissioner is being blamed for the FDA's now typical response to drug applications filed by biotech and pharmaceutical companies. The response: The FDA asks for more information on almost all new drug applications (NDAs) filed. Asking for more information usually leads to at least 12 months
    of additional work for the applying company.

    Thoroughness is important, but without a commissioner to grant the final word, the FDA finds it easy to defer decisions. Following record efficiency in recent years, the FDA's slowdown is one culprit dragging down drug stocks. Others culprits are Capitol Hill's amibition to lower drug prices and its favorable legislation toward generic drugs.
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