Showing archive for: “Administrative Law”
FCC’s Digital-Discrimination Rules: An Open Invitation to Flood the Field with Schlock
A half-dozen lawsuits have been filed to date challenging the digital-discrimination rules recently approved by the Federal Communications Commission (FCC). These cases were consolidated earlier this month and will now be heard by the 8th U.S. Circuit Court of Appeals. This has the hallmarks of a significant case that will almost certainly involve the U.S. ... FCC’s Digital-Discrimination Rules: An Open Invitation to Flood the Field with Schlock
The WHO’s Insufficient Curiosity and Humility
Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly agree to amendments to the International Health Regulations (IHRs), which are intended to “prevent, protect against, prepare, control and provide a public health response to the international spread of diseases.” ... The WHO’s Insufficient Curiosity and Humility
Three Problems with Accelerated Access: Will They Be Overcome?
This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain that, legally, the standards of accelerated approval are the same as standard approval. Yet from a risk perspective, the standards are quite different; by shifting risk taking from regulator to ... Three Problems with Accelerated Access: Will They Be Overcome?
Oncology Drives Most Recent Accelerated Approvals
In my most recent post on medicine approvals I explored how the HIV/AIDS crisis drove a reevaluation of what was truly essential to demonstrate a new drug’s efficacy. Allowing HIV patients to take investigational treatments meant that research into rarer conditions—which previously would never have been profitable—might now be financially worthwhile. This post estimates the ... Oncology Drives Most Recent Accelerated Approvals
Where Are the New FTC Rules?
Perhaps more than at any time in its history, the Federal Trade Commission (FTC) under Chair Lina Khan has highlighted substantive rulemaking as a central element of its policy agenda. But despite a great deal of rule-related sound and fury (signifying nothing?), new final rules have yet to emerge, and do not appear imminent. This ... Where Are the New FTC Rules?
A Brief History of the US Drug Approval Process, and the Birth of Accelerated Approval
This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, how disasters drove its expansion and regulatory oversight, and how the epidemic of the human immunodeficiency virus (HIV) changed the approval processes. The Arrival of New Medicines Lone inventors, ... A Brief History of the US Drug Approval Process, and the Birth of Accelerated Approval
Making Sure New Medicines Are Safe, Effective, and Approved Quickly: A Theoretical Approach
This is the first in what will be a series of posts discussing how new medicines are introduced and regulated in the United States, and how the status quo could be improved. As will be established over the course of the series, the current system is slow and leads to poor outcomes for patients. Why ... Making Sure New Medicines Are Safe, Effective, and Approved Quickly: A Theoretical Approach
Net Neutrality and Broken Records
I don’t mean to sound like a broken record, but why is the Federal Communications Commission (FCC) playing a broken record? I’ve been writing a fair bit about Federal Trade Commission (FTC) rulemaking initiatives. On the theory that you deserve a nominal break from all of that, this post is mostly about the FCC. On ... Net Neutrality and Broken Records
I, For One, Welcome Our New FTC Overlords
In this post—the last planned post for this symposium on The FTC’s New Normal (though we will continue to accept unsolicited submissions of responses)—I will offer some summary of the ideas that have been shared here over the past month, before turning to some of my own thoughts. To keep your attention rapt, I will ... I, For One, Welcome Our New FTC Overlords
Net Neutrality II: Electric Boogaloo—Rate Regulation Hiding in Plain Sight
Federal Communications Commission (FCC) Chair Jessica Rosenworcel on Tuesday announced the agency’s proposal to regulate internet services under Title II of the Communications Act. Commonly referred to as “net neutrality,” the chair plans to release proposed rules today, with a vote scheduled for Oct. 19 to begin the rulemaking process. Rosenworcel’s speech identified several areas ... Net Neutrality II: Electric Boogaloo—Rate Regulation Hiding in Plain Sight
Recent Antitrust and Regulatory Changes Both Unravel the Consensus
Presidential administrations over the last 50 years have pursued widely varying policy goals, but they have agreed—at least, in principle—that policies should be efficient and improve social welfare. Now, the Biden administration is taking steps to unravel that bipartisan consensus. We focus on different policy areas (Dudley on regulation and Sullivan on antitrust) and are ... Recent Antitrust and Regulatory Changes Both Unravel the Consensus
The FTC Tacks Into the Gale, Battening No Hatches: Part 1
The Evolution of FTC Antitrust Enforcement – Highlights of Its Origins and Major Trends 1910-1914 – Creation and Launch The election of 1912, which led to the creation of the Federal Trade Commission (FTC), occurred at the apex of the Progressive Era. Since antebellum times, Grover Cleveland had been the only Democrat elected as president. ... The FTC Tacks Into the Gale, Battening No Hatches: Part 1
