Posted by JohnX2 on October 26, 2001, at 2:15:37
In reply to Re: medication that hasn't been approved, posted by Dr. Bob on October 25, 2001, at 18:19:42
> > > Is it ok to talk about medications that are in
> > > the pipeline? or people who are actually in the
> > > clinical trials? Also, if a medication was obtained
> > > with a doctor's prescription in accordance to
> > > all the FDA guidelines on personal importations,
> > > would it be ok to post one's experience?
>
> Discussing medications and experiences is fine, my concern is just with sharing ways of obtaining them without a prescription. I'm not sure what you mean, talking about people in clinical trials...
>
> > > PS. I'm sure you are well aware of the FDA
> > > rules regarding personal importanations of medications.
> > > It is at their discretion as to whether or not to
> > > allow a medication for a few months be allowed into
> > > the US (with a US doctor prescription).
> > > This "loop-hole" is specifically used to
> > > protect foreign travelers in the US or treatment
> > > refractory US patients.
>
> Right, I've linked to the FDA site from the FAQ. The thing is, *Customs* doesn't say anything about "enforcement discretion"...
>
> http://www.dr-bob.org/babble/faq.html#illegal
>
> BobBob,
Thanks for your follow up.
I can expect that medications not approved
in the us (i.e. specifically denied by the
fda) or on lists of controlled substances make
perfect sense not to be acceptable to discussions
on this board with respect to acquistions.Some meds like Manerix, were never submitted
for FDA approval because the company Roche did
not feel the $$'s required for approval could
overcome the "wrap" given to MAOI's when the
tyramine issues arrose. But there is absolutely
nothing in the us FDA's guidelines indicating
that manerix is a controlled substance, so in
that case I would expect it to be ok to be
discussed.As far as clinical trials, many people have tried
Reboxetine, including people in the us. This med
has never received officia FDA approval in the us;
its in limbo. But people would be interested in their
experience.Anyways, I agree. We need to stay within the bounds
of the legal system. I believe that the
competitive nature inspired by the US capitalistic
system works in our favor with regards to innovation,
(wow, let's see how many new meds pop out as these
SSRI's go off patent). In many cases the fda
is very overbearing and as such the costs to
develop new meds is very prohibiting (for the protection
of our health). Other countries
are more liberal about medication approval. I guess
it is a double edged sword.Thanks for your reply,
John
poster:JohnX2
thread:2069
URL: http://www.dr-bob.org/babble/admin/20010718/msgs/2222.html