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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 …
Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck
Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck
Faculty Publications
Specialty drugs, often dispensed by specialty pharmacies, are among the most expensive drugs on the market. They are significant contributors to the American health care cost problem, but in many ways they escape public and regulatory scrutiny. Surprisingly, medications are designated as specialty drugs by pharmacy benefit managers (PBMs), entities that are part of the insurance industry, rather than by the Food and Drug Administration or medical authorities.
Specialty drugs have thus far received little attention in the legal literature. Yet, they raise important legal and regulatory questions. For example, there are no federal government rules (and only a handful …