Browsing by Subject "healthcare law"

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    Biologics Price Competition and Innovation Act: Striking a Delicate Balance Between Innovation and Accessibility
    (Minnesota Journal of Law, Science and Technology, 2014-02-20) Lu, Ude
    The Biologics Price Competition and Innovation Act of 2009 (BPCIA, also known as the Biosimilar Act) was signed into law in 2010 by President Barack Obama as part of the healthcare reform bill. The central mission of the BPCIA is two-fold: (1) providing sufficient incentives for continuous innovations in biologic therapies (i.e., promoting innovation); and (2) lowering the price of biologic therapies (i.e., promoting accessibility). To promote innovation, the BPCIA provides twelve-year Food and Drug Administration (FDA) exclusivity to innovator biologics. This twelve-year FDA exclusivity prevents generic biologics, also known as follow-on biologics (FOBs), from being approved. To promote accessibility, the BPCIA provides an abbreviated pathway for FOBs—the abbreviated biologic license application (ABLA). The ABLA allows FOB manufacturers to cut short the time and the expensive cost of clinical testing by referring to innovator biologics’ clinical data to establish safety and efficacy. The goal of this Note is to discuss the advantages and drawbacks of the mechanisms established in the BPCIA and to suggest modifications to strike a better balance between innovation and accessibility. Part I of this Note introduces the legal and scientific background of the BPCIA and Hatch-Waxman Act in order to engage in further analyses. Part II of this Note analyzes the competing interests of innovation and accessibility and suggests a novel six-year data exclusivity and a six-to-twelve-year market exclusivity regulatory scheme. This Note concludes that the current design of the BPCIA tips too favorably toward innovation and compromises accessibility. The suggested six-year data exclusivity and six-to-twelve-year market exclusivity regulatory scheme potentially strike a better balance between innovation and accessibility.
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    Developing a Durable Right to Health Care
    (2013-02-12) Fuse Brown, Erin C.
    The Patient Protection and Affordable Care Act’s (ACA) signature accomplishment was the creation of a statutory right to health care for the uninsured. This is a momentous change in policy, addressing one of the most vexing social issues of our time and affecting millions of people and billions of dollars of the U.S. economy. This ambition and the degree of societal and political debate leading up to the Act’s passage suggests that it is a “superstatute,” a rare breed of statute that can, among other things, create rights and institutions more typically thought to be the province of constitutional undertaking. Nevertheless, the structure of the ACA’s right to health care makes it fragile and reduces its chances of becoming a durable right. The ACA may end up as a “quasi-superstatute:” a statute that aspires but fails to become a superstatute through a failure of political and public entrenchment. The problem is that the right to health care is to be delivered largely through changes to the private health insurance market, requiring the collective action of many reluctant actors, including unwilling states and recalcitrant individuals. Even though it survived legal challenge before the Supreme Court, the ACA’s right to health care faces significant political and market challenges that threaten to retrench rather than entrench its benefits in the public’s mind. The vulnerability of this right to health care is concentrated early in its lifespan, and if it survives these early years, forces such as the endowment effect may strengthen the right’s durability as its benefits take hold. The fragility of the ACA’s right to health care and its uncertain path to durability provide lessons to future framers of a right to health care regarding the long timeframe for implementation, uncertainty, complexity, and structure. The risk of becoming a “quasi-superstatute” highlights the importance of how such social reforms ought to be structured to achieve entrenchment and durability after the ink is dry on the new legislation.