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Does anyone know the legality of lengthy quotes from a package
insert? Is it copyrighted? I would like to extract drug interaction
and toxicity tables and make minor formatting changes for a review
article. Source would be referenced of course.
Thank you very much.
--
Michael Neely, MD
Assistant Professor
Division of Pediatric Infectious Diseases
1640 Marengo St., #300
Los Angeles, CA 90033
Laboratory of Applied Pharmacokinetics
2250 Alcazar St. CSC 134B
Los Angeles, CA 90033
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The following message was posted to: PharmPK
Dear Dr. Michael Neely,
You can copy from Package inserts and Summary of product
characteristics. These are scientific information provided by the
companies to general public and healthcare professionals, which are
freely assessable in the regulatory agencies and concerned company
websites. You can quote from both PILs and SmPCs in your review article.
Alternatively you can also download toxicity data (Both RTECS and MSDS)
from the following websites.
http://ccinfoweb.ccohs.ca/rtecs/search.html
http://ccinfoweb.ccohs.ca/msds/search.html
You can assess these toxicity data for free of cost for 7 days by
registering for free trial in the following web link.
http://www.ccohs.ca/products/ordering/freetrial/
Regards,
Dr.S.Gunasakaran, MBBS, MD.
Medical Affairs
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The following message was posted to: PharmPK
Michael;
The answer depends on the country. The information below does NOT
apply to labels from the European Union. But since you are from
California I will assume you are talking about FDA-approved labeling.
The US government takes the stance that government documents like FDA-
approved labels are in the public domain. You can either cite DailyMed
or Drugs.aaa.FDA like any other internet resource. Use in a review would
be considered fair use. Below is a statement from the NLM DailyMed
site (the FDA has a similar statement):
NLM Copyright Information
Government information at NLM Web sites is in the public domain.
Public domain information may be freely distributed and copied, but it
is requested that in any subsequent use the National Library of
Medicine (NLM) be given appropriate acknowledgement. When using NLM
Web sites, you may encounter documents, illustrations, photographs, or
other information resources contributed or licensed by private
individuals, companies, or organizations that may be protected by U.S.
and foreign copyright laws. Transmission or reproduction of protected
items beyond that allowed by fair use as defined in the copyright laws
requires the written permission of the copyright owners. Specific NLM
Web sites containing protected information provide additional
notification of conditions associated with its use.
Sincerely,
Carol Collins MD
University of Washington
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The following message was posted to: PharmPK
Hi Michael!
> Does anyone know the legality of lengthy quotes from a package
> insert? Is it copyrighted? I would like to extract drug interaction
> and toxicity tables and make minor formatting changes for a review
> article. Source would be referenced of course.
According to the 1996 amendments to the Freedom of Information Act
(FOIA) information (including the label) are in the public domain. See
here:
http://www.fda.gov/RegulatoryInformation/FOI/default.htm
Labels given at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
are accessible from the site above.
best regards,
Helmut
Ing. Helmut SchAtz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.aaa.bebac.at
web http://bebac.at/
contact http://bebac.at/Contact.htm
forum http://forum.bebac.at/
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The following message was posted to: PharmPK
Hi Michael
The package insert is typically copyright material but as long as it
is properly cited and used in a fair manner it should be fine to cite.
As a manuscript reviewer, however, I would strongly suggest not
citing the package insert. Package insert themselves are a review of
the data so if one wanted more information on the details of how the
data was derived, the package insert usually does not have these
details. It may be more work, but I think it is preferable to cite
publications or conference abstracts that provide that information.
Of course, some of this may not be available in that format in which
case I suppose the package insert may be the only source. Another
reason not to cite the package insert is that the package insert
sometimes reflects the local Health Authorities interpretation of the
data which may vary from region to region. There are several examples
of drugs where drug interaction recommendations are entirely different
in the US than in Europe or other parts of the world (but based on the
same data!). You need to consider this if your intended audience is
global.
Regards,
Thomas Kakuda, Pharm.D.
Director, Human Pharmacokinetics
Tibotec, Inc.
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