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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One fundamental barrier to eliminating health disparities, particularly with regard to the determinants of health, is the persistence of discrimination. Civil rights law is the primary legal mechanism used to address discrimination. ⋯ The research on state civil rights laws, while more limited, is growing. This article will highlight a few examples of how some states are using civil rights laws to combat discrimination, particularly in more expansive ways and in the interest of new populations, presenting tools that can target determinants and address the goal of reducing health disparities.
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This article explores challenges to accessing opioid treatment programs in rural areas, and offers solutions that would ease these problems.
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This article highlights local government responses to the opioid crisis in Northern Kentucky through a series of interviews with county-level officials. The author's discussions with civic leaders reflect the challenges faced by local communities and the new approaches implemented to stem the epidemic.