I came across this on another e-discussion group. I thought it interesting
and explains a lot .
"Since leaving academia and joining xyz company, I've learned a number
of very interesting things about drug promotion, that I didn't
previously know. While I may have been alone in my prior ignorance,
I thought it might be worthwhile to post these 2 points:
1. Drug promotion must conform exactly to the package insert.
That is, "direct-to-consumer" and "detail person's" sales pitches
can only contain material that is included in the package insert.
Even if a study is published in a peer-reviewed journal (NEJM,
whatever), its findings cannot be advertised/promoted/detailed unless
the FDA has agreed that the study is acceptable and has decided to
include the study on the package insert (usually in the section entitled
"Clinical Studies"). Same holds true for advertisements in professional
journals, mailings to physicians, handouts to physicians, etc.
Detail people are not even supposed to suggest dosing regimens that
differ from the package insert. I believe that they can hand out
published articles that are not described on the package insert, but
they can't talk about them. (Actually, I'm not even sure that this is
truly kosher.) Furthermore, it is rather rare for manufacturers to ask
for revisions to the package insert after the product has been launched.
That's why they pay physicians to give promotional dinner talks and the
like.
Such speakers are likely, of course, to include discussion of recently
published studies, alternative uses, and alternative dosing regimens, though
the drug manufacturer cannot explicitly tell the speaker what to talk about.
Anything else is contrary to FDA regulations, i.e., it is illegal.
2. The PDR is an advertisement.
Drug manufacturers must pay to have their package inserts published
in the PDR. No payment = not published in the PDR. Of course, most
manufacturers do pay for their non-generic prescription drugs to be
included."
Rhoda Taylor and Paul Lazenby
Vancouver Island, Canada

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