American Journal of Law & Medicine. Summer-Fall, 2018, Vol. 44 Issue 2-3, p269, 22 p.
Government regulation, United States. Department of Health and Human Services -- Standards, United States. Food and Drug Administration -- Standards, Medical equipment -- Laws, regulations and rules, Medical equipment -- Political aspects, Medical equipment -- Standards, Physiological apparatus -- Laws, regulations and rules, Physiological apparatus -- Political aspects, Physiological apparatus -- Standards, Pharmaceutical policy -- Laws, regulations and rules, Pharmaceutical policy -- Political aspects, and 21st Century Cures Act of 2015
I. INTRODUCTION In late 2016, Congress enacted, and President Obama signed, the 21st Century Cures Act ('Cures Act') to promote access to new technology and pharmaceutical products.' The [...]
American Journal of Law & Medicine. Winter, 1998, Vol. 24 Issue 4, p443, 1 p.
Genetic discrimination -- Laws, regulations and rules and Medical records -- Access control
Great medical advances also call for legislation barring genetic discrimination by employers and health insurers, barring mandatory genetic testing and protecting the confidentiality of individuals' genetic information. The Genetic Privacy and Nondiscrimination Act of 1997 and the Genetic Confidentiality and Nondiscrimination Act of 1997 should be reintroduced and enacted.The speed of genomic discoveries will probably call for subsequent legislation but these laws are a good start.
American Journal of Law & Medicine. Summer-Fall, 2015, Vol. 41 Issue 2-3, p483, 22 p.
Government regulation, Generic drugs -- Labeling, Exclusive and concurrent legislative powers -- Laws, regulations and rules, Drug approval -- Laws, regulations and rules, Drug Price Competition and Patent Term Restoration Act of 1984, Food, Drug and Cosmetic Act, and Pliva, Inc. v. Mensing (131 S. Ct. 2567 (2011)
I. INTRODUCTION Generic drugs occupy a unique position in the U.S. pharmaceuticals market. On one hand, generics are a product of basic free-market economic reasoning. Congress enacted the [...]
American Journal of Law & Medicine. Winter, 1989, Vol. 15 Issue 4, 461-482.
United States. Patent and Trademark Office -- Laws, regulations and rules, Genetic engineering -- Intellectual property, and Microorganisms -- Intellectual property
The availability of patents for genetically altered animals raises questions about the patentability of human beings. Genetic research will produce beings who fall halfway between what we currently think of as 'animal' and 'human.' It is unclear on which side of the legal line these creatures will fall. In April 1988, Congress revised the Patent Act with a statement that human beings are not to be considered patentable subject matter. Congress, however, failed to supply a definition of the term 'human being.' A definition will clarify the legal status of sub-human creatures. The author addresses this problem and proposes a definition of 'human being' as an amendment to the Patent Act.