Drug Approval in a Learning Health System By W. Nicholas Price II. Full Text Here. The current system of Food and Drug Administration (FDA) approval seems to make few happy. Some argue that FDA approves drugs too slowly; others, too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to…

Regulatory Silence at the FDA By Jordan Paradise. Full Text Here. Action speaks louder than words, but silence often speaks loudest. Where statutory language specifically directs a federal administrative agency to act, the agency must adhere to the conditions and timeframe provided by Congress. Yet the statute may instead give general authority to an agency,…

Dangerous Times: The FDA’s Role in Information Production, Past and Future By Amy Kapczynski. Full Text Here. The FDA faces many current threats to its power as a drug regulator. Many so-called right-to-try bills have passed at the state level, and versions have been introduced federally that could reduce or eliminate the Agency’s ability to oversee…

Delinking Reimbursement By Rachel E. Sachs. Full Text Here. Over the past few years, calls for the Food and Drug Administration (FDA) to approve pharmaceuticals more speedily have grown louder. At the same time, many have argued that America’s drug pricing problems can be solved if only Congress were to give Medicare the authority to…

What Makes Ensuring Access to Affordable Prescription Drugs the Hardest Problem in Health Policy? By Michelle M. Mello. Full text here. Prescription drug costs have risen to an unsustainable level in the United States, accounting for one out of every six dollars spent on health care and compromising many patients’ ability to afford the pharmaceutical…

Infamous Misdemeanors and the Grand Jury Clause By Gabriel J. Chin & John Ormonde. Full text here. Under an overlooked body of constitutional law, many more federal offenses must be prosecuted by grand jury indictment than is now the practice. Current rules provide that felonies must be prosecuted by grand jury indictment, but misdemeanor charges…

Dean David Wippman: Strong Leadership in a Challenging Time By Fionnuala Ní Aoláin & Brett McDonnell. Full text here. David Wippman graduated from Yale Law School in 1982. Within ten years of graduating, he became co-managing partner of a boutique law firm. His love of research and scholarly work, however, drew him to Cornell Law…

Keeping Promises and Meeting Needs: Public Charities at a Crossroads By Allison Anna Tait. Full text here. When a charitable institution cannot fulfill the terms governing a gift agreement, it must decide whether to keep a promise or meet a need. If an institution chooses to keep a promise to a donor, it might not…

By Robert J. Rhee. Full text here. Shareholder primacy is one of the most fundamental concepts in corporate law and corporate governance. It is widely embraced in the business, legal, and academic communities. Economic analysis and policy arguments advance a normative theory that corporate managers should maximize shareholder wealth. Academic literature invariably describes shareholder primacy…

Administrative Answers to Major Questions: On the Democratic Legitimacy of Agency Statutory Interpretation By Blake Emerson. Full text here. This Article critiques the legal and theoretical premises of the major questions doctrine, and proposes a revision to the doctrine that better comports with the institutional structure and ideological origins of our administrative state. The major…