Re: FDA response by Dale Severance

["Charles T. Meyer" <cmeyer@xxxxxxxxxxxxxxx>]

Dale Severance join list wrote:
>
> Last week I attended a luncheon briefing by officials of the FDA. They were
> presenting the goals and accomplishments of the agency to secure continuing
> legislation.
> About two or three years ago legislation was adopted to permit the FDA to
> charge a fee when and application for drug approval was submitted for their
> consideration . The agency was require to set goals and reach those goals
>  to continue receiving these special fees.
>
> The jist of the presentation was that applications have increased 300% in the
> last three years and approval time has been cut in half.
>
> It is my understanding from conversations with some parties that FDA approval
> is held up currently over the content of the statements on the packageing and
> Upjohn can not commercially release the drug till the packaging is
> approved.Dale
>
> dales99846@xxxxxxx
Dale,

It is frustrating but important that the labling be correct.  I am
waiting to start Pramipexole too and want to push the process along.
But the labeling is more than what is just on the box-  It involves what
claims the company can make for the drugs and what level of warning
about side effects needs to be given.  Drug companies notoriously love
to make outlandish claims for drugs.  Most specialists when a new drug
comes out in their field try to get unbiased evaluations of the drugs
but when they get to the level of the generalist who may use the drugs
in that speciality or subspecialty occasionally they often wind up
knowing only the information about the drug that the detail man
(salesman) provides. People have been blaming the FDA or Upjohn.  I
think it is both their faults and the inability apparently is leaving
many of us waiting.

Charlie
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CHARLES T. MEYER, M.D.
MADISON, WISCONSIN
cmeyer@xxxxxxxxxxxxxxx
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