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Articles 1 - 3 of 3
Full-Text Articles in Law
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman
Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman
Articles
A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.
The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite
The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite
Articles
On the thirty-fifth anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set …