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open access

Genetic Exceptionalism: Genetic Information and Public Policy

Description: This report provides an overview of the nature of genetic information and its implications for individuals, family, and society. Individuals utilize genetic information to guide health care and other decisions, when possible, and may experience anxiety as a result of genetic test results. Genetic test results for an individual may often be informative for other close family members and thus influence their care decisions. Society must grapple with the effect genetic information may have on our … more
Date: February 14, 2008
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department
open access

Medical Malpractice Liability Reform: H.R. 5, 109th Congress

Description: This report discusses H.R. 5, which would preempt state law regarding some aspects of medical malpractice liability and liability for defective medical products, including drugs. The legislation would among other things, place caps on noneconomic and punitive damages (in states that have not enacted and do not enact caps), eliminate joint and several liability, modify the collateral source rule, limit lawyers' contingent fees, enact a federal statute of limitations, and provide for periodic pay… more
Date: January 18, 2006
Creator: Cohen, Henry
Partner: UNT Libraries Government Documents Department
open access

Influenza Antiviral Drugs and Patent Law Issues

Description: This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Date: August 16, 2007
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
open access

Stem Cell Research: Ethical Issues

Description: This report discusses the ethical arguments that surround human embryonic stem cell research (ESR). Human stem cell research is controversial not because of its goals, but rather because of the means of obtaining some of the cells.
Date: April 28, 2009
Creator: Williams, Erin D. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

FDA Regulation of Follow-On Biologics

Description: This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
Date: February 24, 2009
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Food Labeling: Allergy Information

Description: Media attention to food allergies is the result of the recent tracking of food allergy sufferers and a clear rise in the number of affected individuals. Several efforts are underway to improve the ability of individuals who have a food allergy to avoid products that cause symptoms that can range from mild to serious. The Food and Drug Administration (FDA) and the Food Allergy Issues Alliance each have released guidelines to address the issues of labeling and cross-contamination. Nine state atto… more
Date: September 19, 2005
Creator: Porter, Donna V.
Partner: UNT Libraries Government Documents Department
open access

The Public Health and Medical Response to Disasters: Federal Authority and Funding

Description: This report examines (1) the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for financing the costs of a respo… more
Date: August 1, 2008
Creator: Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

Background and Legal Issues Related to Stem Cell Research

Description: This report discusses issues regarding stem cell research. With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to "the more than 60" existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the deri… more
Date: October 26, 2004
Creator: Shimabukuro, Jon O.
Partner: UNT Libraries Government Documents Department
open access

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: December 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Partner: UNT Libraries Government Documents Department
open access

Medicare Prescription Drug Proposals: Estimates of Aged Beneficiaries Who Fall Below Income Criteria, by State

Description: This report discusses bills related to Medicare benefits, which include additional assistance for low-income beneficiaries. The assistance would have been in the form of reduced, subsidized or eliminated premiums, deductibles and other cost-sharing. Proposals in the 108th Congress will probably also include some of these features for low-income beneficiaries.
Date: February 11, 2003
Creator: Peterson, Chris L. & Morgan, Paulette C.
Partner: UNT Libraries Government Documents Department
open access

The Public Health and Medical Response to Disasters: Federal Authority and Funding

Description: This report examines, first, the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; second, mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and finally, existing mechanisms, potential gaps, and proposals for financing the cos… more
Date: June 23, 2008
Creator: Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

The Public Health and Medical Response to Disasters: Federal Authority and Funding

Description: This report examines (1) the authorities and coordinating mechanisms of the President and the Secretary of Health and Human Services (HHS) in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for fi… more
Date: August 1, 2008
Creator: Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: August 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Partner: UNT Libraries Government Documents Department
open access

Animal Identification: Overview and Issues

Description: This report provides information about animal identification and proposed solutions. Livestock industry groups, animal health officials, and the U.S. Department of Agriculture (USDA) have been working to establish a nationwide identification (ID) system capable of quickly tracking animals from birth to slaughter, to deal with animal diseases and/or to satisfy foreign market specifications. Some consumer groups are among those who believe ID also would be useful for food safety or retail labeli… more
Date: February 19, 2009
Creator: Becker, Geoffrey S.
Partner: UNT Libraries Government Documents Department
open access

The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases

Description: This report discusses the April 2009 outbreak of the influenza strain known as H1N1, or swine influenza. This report describes the distribution of the virus and the statistics of affected areas, as well as international and U.S. efforts to treat infected persons, respond to outbreaks in various countries, and prepare for a possible influenza pandemic.
Date: May 26, 2008
Creator: Salaam-Blyther, Tiaji
Partner: UNT Libraries Government Documents Department
open access

The 2009 Influenza Pandemic: Selected Legal Issues

Description: Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine legal issues surrounding this emerging public health threat. This report will provide a brief overview of selected legal issues.
Date: May 4, 2009
Creator: Swendiman, Kathleen S. & Jones, Nancy L.
Partner: UNT Libraries Government Documents Department
open access

The 2009 Influenza Pandemic: Selected Legal Issues

Description: Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine legal issues surrounding this emerging public health threat. This report will provide a brief overview of selected legal issues.
Date: May 6, 2009
Creator: Swendiman, Kathleen S. & Jones, Nancy L.
Partner: UNT Libraries Government Documents Department
open access

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Partner: UNT Libraries Government Documents Department
open access

Prescription Drug Coverage Under Medicaid

Description: Medicaid is a joint federal-state entitlement program that pays for medical services on behalf of certain groups of low-income persons. It is the third largest social program in the federal budget, exceeded only by Social Security and Medicare and is typically the second largest spending item for states. This report discusses prescription drug policies under the program.
Date: March 12, 2004
Creator: Hearne, Jean & Grady, April
Partner: UNT Libraries Government Documents Department
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