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Medicinal Products and the Law  

This research guide provides information on selected print and online resources dealing with the regulation of pharmaceuticals, biologics, and other medicinal treatments.
Last Updated: Sep 7, 2014 URL: http://libraryguides.cwsl.edu/medicinal Print Guide RSS Updates
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Scope

This research guide is not all-inclusive. It does, however, present resources available at the CWSL library and online regarding legal issues associated with the development and marketing of pharmaceuticals and biologics. It is designed to provide the researcher with guidance as to the location of materials dealing with this subject. Additional research can be conducted by using the KIM system, legal periodical indices, and other finding aids.  Access to licensed databases is limited to students and faculty at CWSL.  We welcome suggestions for improvement on this and other research guides.  Please consult the Reference Librarian with suggestions and further research questions.  This research guide was originally compiled August 1998.  It was most recently revised in July 2010.

 

General Reference

Print Resources

Physicians' desk reference: PDR. Oradell, NJ: Medical Economics Co.
Location: Reserve
Call No.: RS250 .P4

PDR for nonprescription drugs, dietary supplements and herbs, 29th ed.. Montvale, NJ: Thomson Health Care. 2008.
Location: Reference
Call No.:  
RM671.A1 P48 2008

Bio-science law review. [Oxford?] : Lawtext Publishing Ltd., c1997-
Location: International 3rd Floor-Periodicals
Call No.: K1519.B54 A15


Internet Sites

RxList - The Internet Drug Index
http://www.rxlist.com

·         This site is searchable by keyword. It provides information on a drug's description, use, interactions, adverse reactions, and possible dependency.

Medline
http://www.ncbi.nlm.nih.gov/pubmed/

·         This site is produced by the National Library of Medicine. It is a database of medical journal article citations, some with abstracts. This resource can be used to find current research on pharmaceutical products.   PubMed Central at http://www.pubmedcentral.nih.gov/ provides free access to full-text journal articles.

 

Licensed Databases

These resources are available only to CWSL students and faculty.  If you have questions on accessing these services, please see a Reference Librarian.

 Lexis-NexisLexis-Nexis’ Medical & Health Care Library contains many useful resources in the area of health care law.  This database has a large variety of primary legal resources, secondary sources, and nonlegal items.  To access these resources, click on the News & Business tab, next click on “Science & Technology,” and thenMedical & Health Care.” You can then choose from a list of sources available on this topic.


Westlaw: 
Westlaw also contains a large variety of primary and secondary legal sources, as well as some interdisciplinary files.  Relevant databases on Westlaw include the following:
1.            Pharmaceutical Business News:  Database ID:  PHARMBUS.  Contains abstracts of articles.
2.            Pharma Japan:  Database ID:  PHARMAJ.  Contains abstracts of articles.
3.            Biological Therapies in Dentistry:  Database ID:  BIOTHERDENT.  Contains full-text articles.

 

JSTOR:  This database provides full-text access to multidisciplinary journal articles.  You can limit your access by checking “Health Policy” in the “Advanced Search” mode.

 

Development and Regulation

Print Resources

Epstein, Richard A.  Overdose : how excessive government regulation stifles pharmaceutical innovation.  New Haven : Yale University Press, c2006.
Location:  3rd Floor
Call No.:  HD9666.6 .E68 2006

 Hawthorne, Fran.  Inside the FDA : the business and politics behind the drugs we take and the food we eat.  Hoboken, N.J. : J. Wiley, c2005.
Location:  3rd Floor
Call No.:  RA401.A3 H39 2005

 Journal Articles

--Peter Lurie & Allison Zieve, Sometimes the silence can be like the thunder:  access to pharmaceutical data at the FDA, Law and Contemporary Problems, Summer 2006, at 85. [Journal title available in 3rd Floor Periodicals section of the library and on Hein Online.]

--Robert Rogoyski, The Orphan Drug Act and the Myth of the Exclusivity Incentive, 7 Colum. Sci. Tech. L. Rev. 1 (2005) [Available in full-text from Index to Legal Periodicals and Books (online)}

Internet Sites

U.S. Food and Drug Administration
http://www.fda.gov   
The FDA is an agency important to the pharmaceutical industry. Its web site provides links to a site index, regulatory docket information, and a site-specific search engine.

CenterWatch
http://www.centerwatch.com/
This page is divided into two sections – resources for patients and resources for the industry. Links are provided to information on clinical trials, new FDA approvals, and industry news.

ClinicalResearch.com, Introduction to How Drugs are Developed (2009) [video], http://www.youtube.com/watch?v=wvDvAEmq-cM&feature=related
This short video presents and easy-to-understand outline of the drug approval process.

 

Intellectual Property

Print Sources

Barfield, Claude E., and John E. Calfee.  Biotechnology and the patent system : balancing innovation and property rights.  Washingon, D.C. : Published for the American Enterprise Institute [by] AEI Press, c2007.
Location:  4th Floor
Call No.:  KF3133.B56 B37 2007

Hope, Janet.  Biobazaar:  the open source revolution and biotechnology.  Cambridge, Mass.:  Harvard University Press, 2008.
Location:  3rd Floor
Call No.:  K1519.B54 H67 2008

Patenting lives : life patents, culture and development.  Aldershot, England ; Burlington, VT : Ashgate Pub., c2008.Location:  3rd Floor
Call No.: 
K1519.B54 P378 2008 

Internet Sites

U.S. Patent and Trademark Office
http://www.uspto.gov/
Another federal agency important to the pharmaceutical industry is the U.S. Patent and Trademark Office. The PTO's web site provides links to a site index and a site-specific search engine

U.S. Dept. of Health and Human Services, Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (2010), at http://alturl.com/v7qm 
This lengthy government report analyzes this issue of patenting genetic material and its impact on health care access.

 

Medical Marijuana

Print Resources

Mack, Alison.  Marijuana as medicine?:  the science behind the controversy.  Washington, DC:  National Academy Press, 2001.
Location:  3rd Floor
Call No.:  RM666 .C266 M325 2001

Journal Articles

--Alex Kreit, Comment, The Future of Medical Marijuana: Should the States Grow Their Own?, 151 U. Pa. L. Rev. 1787 (2003) [Available in 3rd Floor Periodicals section of the library and on HeinOnline]

  

--Kathleen T. McCarthy, Conversations about medical marijuana between physicians and their patients.25 J. Legal Med. 333 (2004).[Available on Lexis]

 

Internet Sites

 

City of San Diego, Medical Marijuana Task Force
http://www.sandiego.gov/medicalmarijuana/

 

Americans for Safe Access
http://www.safeaccessnow.org/

 

National Organization for the Reform of Marijuana Laws
http://www.norml.org/

 

Partnership for a Drug-Free America
http://www.drugfree.org/

 

U.S. Drug Enforcement Administration, Speaking Out Against Drug Legalization (2003), http://www.justice.gov/dea/demand/speakout/speaking_out-may03.pdf

 

 

 
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