FDA Struggles to Pinpoint Impacts of Proposed Rule
In February, the Food and Drug Administration (FDA) released a long-awaited proposed rule creating national standards for companies in the prescription drug supply chain.
Our Commentaries and Insights are short-form publications intended to distill long-form research and synthesize current policymaking activity into easily understood concepts.
FDA Struggles to Pinpoint Impacts of Proposed Rule
In February, the Food and Drug Administration (FDA) released a long-awaited proposed rule creating national standards for companies in the prescription drug supply chain.
In recent years, the Chinese government has increasingly flexed its economic, political, and military muscles around the world. Close to its mainland home has been no exception, as the Chinese government has taken actions to pressure officials in Hong Kong and Taiwan.
Possibilities and Perils of Deepfake Technology
While the potential for deepfake technology to disrupt society has been clear for years, its growing accessibility and high-profile instances of use have increased concerns over their capabilities. In the first of a planned series discussing deepfake regulation, this post summarizes some of the most significant costs and benefits of the technology.
Memos to the New OIRA Administrator
President Biden’s Modernizing Regulatory Review memorandum signals continuity in some regulatory practices and big shifts in others.
Supervising the Guantanamo Tribunal Supervisor after Arthrex
The Supreme Court held in United States v. Arthrex that administrative patent judges’ decisions must be subject to agency-head review because they were not appointed as principal officers.
Important Changes at the Intersection of Antitrust and Administrative Law
The Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice will soon publish new joint guidelines applicable to mergers that raise horizontal issues in the same market and to mergers that raise vertical issues in the same supply chain.
National Academies Workshop on Methadone Regulations
A recent National Academies workshop on the federal rules governing methadone treatment explored how these rules restrict patient access to life-saving treatment for opioid use disorder. As the overdose epidemic rages on, these regulations need an overhaul. Recent research from the Regulatory Studies Center, with support from the Pew Charitable Trusts, sheds light on promising pathways for reform.
EPA's New Science Advisory Process
EPA’s new process for engaging its science advisors would embed them in every step of the rulemaking process, which risks diminishing the independence of their review and possibly foreclosing consideration of important research, perspectives, and policy options.
Notice and Comment Policymaking During Uncertain Times
The notice and comment process—in which governments make public draft policies and solicit feedback on these proposals—is seen as a vehicle for promoting transparency, participation, and responsiveness in policymaking.
Comparing Regulatory Uncertainty with Other Policy Uncertainty Measures
Economic research shows that increased uncertainty can lead to significant reductions in hiring, investment, consumption, and output in the economy. Among many types of uncertainty, policy uncertainty has gained increased attention during recent years.