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Full-Text Articles in Health Law and Policy
The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa
The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa
William & Mary Business Law Review
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Faculty Publications By Year
There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …