FDA ruling on support of dissemination (Albert Henderson) ERCELAA@ctrvax.Vanderbilt.Edu 26 Jan 1995 21:06 UTC
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