The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. ⋯ It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.
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Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. ⋯ Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.
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Federal Indian law is the body of law that defines the rights, responsibilities, and relationships between three sovereigns, Tribes, states, and the federal government. This area of law has defined, oftentimes poorly, the contours of treaty rights, criminal and civil jurisdiction, economic development, among other issues. Much has been documented in terms of the implications of social, legal, political, and economic systems that perpetuate inequities amongst American Indian and Alaska Native populations. ⋯ For years, law has been described as a tool to promote health and even a determinant of health. And while research has explored Tribal health laws and federal Indian health policies, more needs to be analyzed in terms of the role of foundational principles of federal Indian law in perpetuating health disparities. This article argues that federal Indian law is a structural determinant of health by linking health disparities to the constructs of this body of law.