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Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
Robin C Feldman
The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a …
Whose Body Is It Anyway? Human Cells And The Strange Effects Of Property And Intellectual Property Law, Robin C. Feldman
Whose Body Is It Anyway? Human Cells And The Strange Effects Of Property And Intellectual Property Law, Robin C. Feldman
Robin C Feldman
Whatever else I might own in this world, it would seem intuitively obvious that I own the cells of my body. Where else could the notion of ownership begin, other than with the components of the tangible corpus that all would recognize as "me?" The law, however, does not view the issue so neatly and clearly, particularly when cells are no long in your body. As so often happens in law, we have reached this point, not by design, but by the piecemeal development of disparate notions that, when gathered together, form a strange and disconcerting picture.
This article examines …
The Intellectual Property Landscape For Ips Cells, Robin C. Feldman
The Intellectual Property Landscape For Ips Cells, Robin C. Feldman
Robin C Feldman
Beginning in 2006, induced pluripotent stem cells have raised the tantalizing possibility that stem cell research could move forward without the significant moral and ethical dilemmas that have paralyzed the field. These cells, known as iPS cells, originate from adult somatic cells, but function in a manner that is almost equivalent to embryonic stem cells. If iPS cell research lives up to its promise, stem cell research, diagnostics, and treatment could be accomplished without destroying or in any way interfering with human embryos or their development.
While we may be entering a historic moment in stem cell research, we are …