Date: Thu, 26 Jan 1995 12:34:12 -0500 (EST)
From: Albert Henderson <70244.1532@COMPUSERVE.COM>
Subject: FDA ruling on support of dissemination

The Following pertains to the cost of library materials and may be
of interest to your newsgroup. The comment period closes 16 Feb.,
so other interested parties and groups may wish to comment.

Statement of Albert Henderson, Editor, Publishing Research Quarterly,
in response to the Notice in the Federal Register Friday, Nov. 18,
1994, page 59820, "Citizen Petition Regarding the Food and Drug
Administration's Policy on Promotion of Unapproved Uses of Approved
Drugs and Devices; Request for Comments"

TO:
Dockets Management Branch
Food and Drug Administration
Room 1-23       (HFA-305)                         January 30, 1995
12420 Parklawn Drive
Rockville, MD  20857
                               RE: Docket 92N-0434

I wish to confine my comment to answering question 3, "how might the
draft policy statement preclude health care professionals and patients
from receiving important scientific information..." The FDA has
generally overlooked the actual mechanics of dissemination used by
educators and researchers and the central role of research libraries in
that process.

Direct dissemination by manufacturers responding to requests and by
circulation of journals is important but not the major avenue of
dissemination of scientific and educational information. The rising
flood of information has exceeded the capacity of individual
investigators and clinicians to keep abreast of reported research for
over 150 years. Researchers in particular have depended increasingly on
libraries, especially on a relative handful of academic and public
research libraries around the world, to supply the full text of
reports, reviews, symposia papers, and other "enduring" information.
They identify these sources primarily through citations in the
literature, informal contacts, browsing the collections themselves and,
more recently, electronic databases and current awareness services. For
a number of economic reasons, these libraries are unable to keep up
with the flood of published information. Their collections have been
falling behind and failing to supply requested items, as described in
the enclosed article, "The Bottleneck in Research Communications"
(Publishing Research Quarterly 10,4:5-21).

Therefore it would be in the interest of promoting the "common good"
aims of education and research for FDA policy to encourage regulated
manufacturers to support the cost of adding materials of enduring
scientific and educational value to the collections of research
libraries, to support the costs of independent preparation of reviews,
synoptics, databases, and and to underwrite other forms of
communication such as symposia and electronic exchanges that help
investigators to identify information and investigators of interest.

[Signed] Albert Henderson, Editor, Publishing Research Quarterly,
Box 2423 Noble Station, Bridgeport CT 06608-0423 FAX 203-380-1703
Telephone 203-367-1555        INTERNET: 70244.1532@compuserve.com