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Lactation Information and Discussion

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Subject:
From:
Lisa Marasco IBCLC <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Sat, 12 Jun 2004 00:27:45 -0700
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>>It's not a new drug, it's been around so long that other companies
could make the generic form.  So, Janssen would lay out the big buck
(extremely large bucks) to apply to FDA to get it approved and then US
pharmaceuticals could make the generic and Janssen would likely lose
money on the whole deal not even breaking even.<<

So this is the crux of the problem--- the FDA process is EXPENSIVE and
the company who lays out the money may not get it back in sales. It's
about MONEY, not safety. So is there some way to circumvent this? Where
can we apply pressure to smooth out the red tape?

>>The makers of Motillium, Janssen, tried for 14 years to get the drug
past the FDA and the makers of Reglan (which has its own list of serious
side effects, especially for use beyond a few weeks) blocked it (on the
side) each time they tried. They say that it costs them too much to keep
submitting it<<

Is this true? Is there a way to document this?

The domperidone situation has been operating under the radar for several
years. Now that it has surfaced and drawn attention, it is time to
tackle it officially. The only question is of where is the best place to
start?

~Lisa Marasco

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