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Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011-2023: a cross-sectional analysis
No full textObjectives To assess the specificity of postmarketing requirement (PMR) statements and associations between PMR statement specificity and PMR study characteristics, timeliness and regulatory decisions. Methods and analysis This was a cross-sectional analysis of publicly available Food and Drug Administration (FDA) databases to characterise PMR statements for oncology accelerated approvals (AAs) between January 2011 and July 2023. Characteristics of trials supporting AA and PMR studies were identified from product labels on the Drugs@FDA database and ClinicalTrials.gov. Main outcomes and measures included PMR statement characteristics, PMR study submission timeliness (on-time vs late) and regulatory decision (regular approval vs withdrawal). Results We analysed 181 PMR statements for 161 oncology indications. Most PMR statements specified target population (98%), endpoints (81% (44% included clinical endpoints; 37% surrogate endpoints only)), use of randomisation (63%) and comparator (54%). Fewer PMR statements specified a particular trial or protocol (45%), follow-up duration (30%), enrolment targets (26%), multicentre trial (24%), double-blinding (13%) or enrolment diversity (8%). PMR statements for indications granted regular approval were more likely than those for withdrawn indications to specify follow-up duration \u3c 1 year (27% vs 0%, p\u3c 0.001), allow endpoints other than overall or progression-free survival (27% vs 4%, p=0.01) and mention a specific trial or protocol (71% vs 36%, p=0.003). Compared to those submitted late, on-time PMR studies had fewer sites (110 vs 156, p=0.03), less use of blinding (20% vs 42%, p=0.02), more use of a continuous trial for AA and PMR (37% vs 8%, p=0.003) and more use of primary endpoints other than overall or progression-free survival (37% vs 6%, p\u3c 0.001). Conclusion PMR statement specificity for oncology AAs varies substantially. Less rigorous PMR statement and study characteristics were associated with timely PMR study submission and transition to regular approval but with important trade-offs. Given that AAs are granted without demonstrated clinical benefit, improving the balance between PMR study timeliness and rigour should be a priority when negotiating PMR statements
Dollars at War: Unraveling the Paradox of China\u27s Military Procurement
Full text linkIn the era of great power competition between China and the United States, one assumption is that China is unencumbered by the same constraints as the United States’ acquisition system, which includes considerations such as veterans’ preference and open competition. A closer look at China’s laws and regulations for military procurement, analyzed under the modernization theory of economic growth, suggests that existing legal incentives may not set conditions for a sufficiently innovative defense industrial base for technological procurement, though massive state investment and market forces can explain its successes in the area. To address the demands of great power competition, the United States has already undertaken measures to enhance its procurement processes. However, it is equally crucial to perform alternatives analysis to assess whether less sophisticated technologies can yield comparable outcomes as advanced technologies, especially in situations where cost-effectiveness is paramount
Corporate Criminal Liability in Taiwan: Challenges, Innovations, and Evolving Legal Frameworks
No full textTaiwan is grappling with challenges regarding the reform of corporate criminal liability laws. Rather than having general provisions in the Criminal Code, corporate criminal liability in Taiwan is mainly prescribed in various specific laws, such as the Banking Act and the Trade Secret Act. Moreover, it lacks the fundamental rules for establishing criminal liability, such as determining the mental state of a legal person. Hence, Taiwan has adopted a unique “double punishment” mechanism that allows for multiple penalties for a single offense, i.e., punishing both natural persons and the legal entities to which they belong. The high-profile case, Micron vs. UMC, highlights the importance of how Taiwanese courts handle matters involving corporate criminal liability and how companies assert their defense claims. This case exemplifies corporate criminal liability defense under the Trade Secret Act, offering insights into the legal complexities. Recent amendments, including those to the National Security Act and Civil Torts Law, demonstrate ongoing efforts to strengthen Taiwan’s corporate liability framework. These efforts emphasize the need for a robust framework for analyzing corporate behavior and misconduct, highlighting the importance of corporate criminal liability in safeguarding public interests
The Law and Politics of International Recognition
No full textWho is the government of a sovereign state in the eyes of the world? Recent crises across multiple continents have violently demonstrated that the answer to this question is sometimes contested. In these situations, one state may recognize (or not recognize) a particular individual or group as the government of another. But recognition does not have a single agreed- upon meaning. Scholars and states have described it in various ways. The result of this conceptual confusion is that when one state recognizes the government of another, it is not always clear what consequences may follow. Decision-makers—in the United States, the President—need guidance about what they can and cannot legitimately accomplish with recognition if they wish to provide a satisfactory response to disputes about who governs.
In this Article, I articulate a novel conceptual framework for understanding how recognition can legitimately operate in the international system of law and power. I argue that recognition exhibits a conceptual symmetry between its inputs and its effects that implies limits on what the act may accomplish. I then argue that the recognition practice of the United States, as illustrated by its approach to crises in Libya, Venezuela, and Afghanistan, is distinctly asymmetrical. For reasons with roots in constitutional authority and domestic legislation, the United States tends to make discretionary decisions on recognition whose consequences violate international law.
However, the decision-maker’s task is not ended by a verdict of unlawfulness. The United States’ approach to recognition must account for the national interest as well as international law’s interest in promoting public order and human dignity. I argue that these interests would generally be better served by recognizing symmetrically. As evidenced by the United States’ actual practice, refraining from the sorts of interventions that asymmetrical recognition entails may be politically difficult in the short term. In a complicated world of imperfect options, however, it will often be the wiser choice over the long term
This Land is My Land (and Definitely Not Yours): Special Interests and Restrictions on Foreign Land Ownership
No full textA wave of legislation preventing and limiting land ownership by foreigners is making impact across the United States. Unfortunately, restrictions on land ownership have often been vulnerable to serving special interests rather than the noble interest they are “intended” to serve. Special interests plague the suboptimal legislation that many states are adopting. Restrictions on foreign land ownership are not unique to the United States, and many jurisdictions around the world have taken unique approaches to this type of legislation and regulation. That being said, none are perfect and many fall victim to the classic bootleggers and Baptists story in which the noble intentions are overshadowed by special interests. The United States must acknowledge the vulnerability of this type of legislation and seek to avoid the common characteristics that historically limit the optimality of legislation that limits foreigners’ right to purchase and own land. A failure to do so has great potential to result in the same suboptimal results already seen in state legislation and across the globe.
A Free State
No full textIn 1856, fourteen people held as slaves—two adult women, their eleven children, and one grandchild—appeared in a Los Angeles courtroom. They were the subjects of a writ of habeas corpus, the most powerful legal tool available to abolitionists. Theirs was the largest freedom suit California history. The controversy surrounding the case affected the judge and the small free Black population of Los Angeles. Latter-day Saints, proslavery southern migrants to southern California, elite Californios, and even the governor were also drawn into the dramatic confrontation between slavery and freedom in Los Angeles. The 1850 California constitution outlawed slavery. Why was a seemingly straightforward freedom suit so hotly debated? Slavery was protected in California, thanks especially to its Supreme Court. Racialist proslavery and abolitionism converged in California in the mid-1850s, in ways that can be seen by exploring new sources and making connections between more familiar records that previously had not been placed in conversation. This article illuminates the importance of gender, faith, migration, and the changing place of localism in American life and law before the Civil War. This history highlights proslavery law and attitudes in 1850s California, and the success of the slave colony, San Bernardino. The freedom of all fourteen people claimed as slaves was an unexpected result, given the legal and political dominance of proslavery forces in the region. The defendant apparently had no stomach for a court battle, however, and he skipped town
Using Experience Smartly to Ensure a Better Future: How the Hard-Earned Lessons of History Should Shape The External and Internal Governance of Corporate Use of Artificial Intelligence
No full textArtificial intelligence or “AI” has transformative potential. But that reality should not obscure the fact that our society has longstanding experience with the corporate development of novel technologies that pose the simultaneous potential to better human lives and to create massive harm. This article, prepared for the occasion of the 50th anniversary of the Journal of Corporate Law and for the Rome Conference on AI, Ethics, and the Future of Corporate Governance, looks backward at the prior experience with corporate profit-seeking through the development and use of transformative technologies to suggest policy measures that might help ensure that the benefits of AI’s development by for-profit business entities to society far exceed its downside
Bonham\u27s Case and Judicial Duty
No full textBonham’s Case is perhaps one of the most famous cases in the common law tradition. It is also one of the most poorly understood. Chief Justice Edward Coke appears to endorse a power of judges to invalidate acts of Parliament that violate reason, natural law, or some other higher law. This reading is wrong. Proving why, however, has challenged the academy for the past hundred years. This paper takes up that labor.
Part I summarizes the case, the opinion, and the surrounding literature. Part II surveys the early modern conventions of statutory interpretation, including competing theories of voidance and hermeneutics deployed in contract and property law. Part III reconstructs Coke’s drafting process by focusing on the neglected prefatory clause of the famous passage (“And it appeareth in our Books, that . . .”). By focusing on the start of the famous passage, we find that Coke likely drew from his own theory of repugnant acts in The Case of Alton Woods. Part IV compares the two cases, showing that Coke intended the famous passage to be narrowly understood as limited to specific impossibility scenarios. Often overlooked is the role of confirmatory acts of Parliament, acts which traditionally receive special interpretive treatment. Part V, finally, assesses Coke’s essential judicial commitments and harmonizes his views in Bonham’s Case with his broader theory of judicial duty. Judges are obliged to apply the law of England, which sometimes aligns and sometimes does not align with the law of nature
Spirit
Full text linkThe Founders were not textualists. The letter of the law mattered quite a bit. But, as William Blackstone noted, interpretation also required the consideration of purpose, reason, and intent—what he and many others called “spirit.” This Article makes several contributions. First, spirit was a potent factor, for it not only helped resolve textual ambiguities, it also could trump the letter of the law. Specifically, spirit could extend the meaning of the law beyond its letter—extensive interpretation. And spirit could restrict the meaning suggested by the letter of the law—restrictive interpretation. Second, spirit was a familiar tool, applicable to constitutions, laws, treaties, judicial precedents, and even executive rules. Third, spirit was not the peculiar province of the courts. Instead, spirit was more democratic, for everyone made free use of it. Early federal legislators, including James Madison, invoked spirit to make sense of the Constitution. Executives, including George Washington, Alexander Hamilton, Thomas Jefferson, and many others, utilized spirit to make sense of the Constitution, laws, and treaties. John Marshall deployed spirit to trump the letter before he was Chief Justice and continued invoking spirit while on the bench. This excavation of Founding-era practices bears on modern debates. To begin with, the Founders eschewed the extreme fixation on text that characterizes modern textualism. Relatedly, given that the Founders routinely considered spirit, textualists should reassess their claim that the Constitution mandates modern textualist precepts. One should not use a late twentieth-century theory to make sense of late eighteenthcentury documents, including the Constitution. Lastly, originalists of all stripes should refine their understanding of originalist methodology, for a proper conception of originalism should perhaps reflect the actual practices of the Founders. Public meaning originalists, original methods originalists, and every other species of originalist must reckon with spirit’s central role in early American practice. For too long, we have been in the thrall of a textualism that is at war with the pervasive use of spirit at the Founding