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Full-Text Articles in Law
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Michigan Journal of Environmental & Administrative Law
Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …
Establishing A More Effective Safmr System: The Cost And Benefits Of Hud's 2016 Small Area Fair Market Rent Rule, John Treat
University of Michigan Journal of Law Reform
This Note analyzes the new HUD rule finalized in November 2016, which dramatically changed the structure of the Housing Choice Voucher program in select metropolitan areas. In August 2017, HUD suspended automatic implementation of the rule until 2020 for twenty-three of the twenty-four selected metropolitan areas, but in December 2017, a preliminary injunction was granted requiring HUD to implement the rule as of January 1, 2018. The rule as written changes the method for calculating the vouchers from using a metropolitan area-wide average to calculating a separate level for each zip code. Such a change could greatly deconcentrate poverty and …
Third-Party Institutional Proxy Advisors: Conflicts Of Interest And Roads To Reform, Matthew Fagan
Third-Party Institutional Proxy Advisors: Conflicts Of Interest And Roads To Reform, Matthew Fagan
University of Michigan Journal of Law Reform
With the rise of institutional activist investors in recent decades—including a purported 495 activist campaigns against U.S. corporations in 2016 alone—the role that third-party institutional proxy advisors play in corporate governance has greatly increased. The United States Office of Government Accountability estimates that clients of the top five proxy advisory firms account for about $41.5 trillion in equity throughout the world. For several years, discussions have developed regarding conflicts of interest faced by proxy advisors. For example, Institutional Shareholder Services, the top proxy advisory firm in the world, frequently provides advice to institutional investors on how to vote proxies while …
Grasping For Energy Democracy, Shelley Welton
Grasping For Energy Democracy, Shelley Welton
Michigan Law Review
Until recently, energy law has attracted relatively little citizen participation. Instead, Americans have preferred to leave matters of energy governance to expert bureaucrats. But the imperative to respond to climate change presents energy regulators with difficult choices over what our future energy sources should be, and how quickly we should transition to them—choices that are outside traditional regulatory expertise. For example, there are currently robust nationwide debates over what role new nuclear power plants and hydraulically fractured natural gas should play in our energy mix, and over how to maintain affordable energy for all while rewarding those who choose to …
Why Guidance From The Supreme Court Is Required In Redefining The Particular Social Group Definition In Refugee Law, Liliya Paraketsova
Why Guidance From The Supreme Court Is Required In Redefining The Particular Social Group Definition In Refugee Law, Liliya Paraketsova
University of Michigan Journal of Law Reform
One of the most debated topics in refugee law has been the meaning of particular social group (PSG)—one of the five categories used to claim refugee status. In 2006, the Board of Immigration Appeals (BIA) adopted a narrower PSG definition. Since that adoption, a circuit split has persisted over the meaning of PSG. Two circuits in particular have continually refused to adopt this definition—even when the BIA attempted to revise the definition in response to their criticism. This Note proposes a reform that would include a compromise between the two current definitions of PSG by rejecting the BIA’s particularity requirement …
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Michigan Law Review
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …