X-Vmsmail-To: smtp%"medlib-l@ubvm.cc.buffalo.edu"
Newsgroups: bit.listserv.medlib-l
Date:         Mon, 12 Oct 1992 15:47:40 -0500
From:         "(LANGMAN, MARY)" <MLANGMAN@LIFE.JSC.NASA.GOV>
Subject:      FDA EMBARGO

TO:      MLA Board of Directors, AAHSLD ListServ, MEDLIB-L
FR:	 Carla J. Funk\
RE:	 FDA Embargo
DATE:	 October 12, 1992
CC:	 Naomi Broering, MLA Governmental Relations Committee, Kent Smith,
	 Lois Ann Colaianni, EDO 3.1.1 FDA Advertising Regs

MLA headquarters staff have worked with Lois Ann Colaianni and Kent
Smith of NLM, MLA Governmental Relations Committee chair Sara Jean Jackson,
and BMLA editor Naomi Broering to monitor comments and coordinate a response
concerning the embargo of journal supplements advertising drugs not having
FDA approval.

The FDA has provided us with the following statement:

Question:  Why has the FDA embargoed supplements to some journals?

Answer:  There is no FDA "embargo" on any journal supplements.  Libraries
are free to obtain and use journal supplements from any source without fear
of regularity action by FDA.

Decisions regarding distribution of supplements in the United States are
made by the distributors of the supplements.  In certain circumstances,
companies that fund supplements may choose not to distribute the supple-
ments in the United States to avoid possible liability under the Federal
Food, Drug, and Cosmetic Act.  Journal supplements can be subject to
regulation by the FDA as labeling or as advertisements if the supplements
appear to promote a company's products and are funded and controlled by that
company.  Companies can be liable for labeling or advertising that is false
or misleading or that promotes an unapproved use for their products.

Decisions by these companies or their distributors to restrict distri-
bution of the supplements in the United States do not constitute or reflect
any FDA embargo.  FDA does not embargo supplements, nor does it regulate the
use of promotional materials by individuals and institutions not involved
in product promotion.  Libraries are thus free to obtain and use such
materials from any source without fear of regulation or oversight by the
FDA, regardless of whether the FDA deems journal supplements or other
materials to be improper labeling or advertising, or whether companies
choose to support the distribution of such supplements.

Actions Being Taken:

Since libraries are not prohibited by FDA regulation to obtain copies of
journal supplements, actions are being taken to secure information on how
to order these supplements.  Some of these actions have been reported
in previous e-mail messages.

(1)  The Journal on Oncology is sending Lois Ann Colaianni the supplements
that were recently witheld.

(2)  Lois Ann is working with the FDA to gather material that libraries
can use to contact the journals directly to request the supplements.  This
information will be posted to AAHSLD and MEDLIB-L listservs.

(3)  Academic Medicine is considering an editorial on the issue.  Naomi
Broering is gathering comments.  If you wish to submit comments, they can
be sent to Naomi at BROERINN@GUNELIB.GEORGETOWN.EDU

(4)  MLA staff will continue to monitor this issue and communicate new
findings over e-mail.

We appreciate the efforts of everyone involved in gathering information
and taking action on this issue.
Comments: Gated by NETNEWS@AUVM.AMERICAN.EDU