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Articles 1 - 4 of 4
Full-Text Articles in Health Law and Policy
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Saint Louis University Journal of Health Law & Policy
Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
All Faculty Scholarship
Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …
Introducing Patient Scope Of Care: Psychologists, Psychiatrists, And The Privilege To Prescribe Drugs, Rachel P. Berland
Introducing Patient Scope Of Care: Psychologists, Psychiatrists, And The Privilege To Prescribe Drugs, Rachel P. Berland
Saint Louis University Journal of Health Law & Policy
No abstract provided.
Independent Clinical Trials To Test Drugs: The Neglected Reform, Marc A. Rodwin
Independent Clinical Trials To Test Drugs: The Neglected Reform, Marc A. Rodwin
Saint Louis University Journal of Health Law & Policy
No abstract provided.