Measuring the Effectiveness of the 340B Program

From: Center for Regulatory Effectiveness via SSRN

Bruce Levinson


Virtually every aspect of the 340B drug discount program has been evaluated except its effectiveness at improving healthcare access for medically underserved populations. This paper seeks to fill this information gap by using federal data to measure changes in the ability of impoverished and uninsured patients to afford needed healthcare, relative to the general population. The paper finds that the 340B program is harming the relative affordability of needed prescription drugs, needed medical care, and needed dental care for the most medically underserved communities. The causes of this decline in affordability is traced to a three-fold process that 340B hospitals are using to take maximum advantage of the program’s financial incentives.

Soft Law for Hard Problems: The Governance of Emerging Technologies in an Uncertain Future

From: Colorado Technology Law Journal via SSRN

Ryan Hagemann, Jennifer Skees, Adam D. Thierer


For a great many emerging technologies, as well as many existing ones, we are witnessing the twilight of the traditional regulatory system and its gradual replacement by an amorphous and constantly-evolving set of informal “soft law” governance mechanisms. This has profound ramifications for the future of statutory law, administrative regulation, and the evolution of a wide variety of technology sectors.

OMB Leveraging the CRA to Add to Its Oversight of Independent Regulatory Agencies

From: Notice & Comment | A Blog from the Yale Journal on Regulation and the ABA Section of Administrative Law & Regulatory Practice

William Funk


Despite the language of the CRA that clearly includes guidance documents as rules subject to its provisions, many, if not most, agencies did not send guidance documents to the House and Senate as the CRA required. The Government Accountability Office opined in 2017 that guidance documents were subject to the CRA, and at least two district courts have entertained suits claiming that an agency violated the CRA by not submitting guidance documents to Congress. The new OMB memo specifically notes that guidance documents are subject to CRA requirements.

Extraterritoriality in the Public and Private Enforcement of U.S. Regulatory Law

From: Indiana Legal Studies Research Paper No. 408

Forthcoming in The Continuing Relevance of Private International Law and Its Challenges (F. Ferrari & D. Fernandez Arroyo eds., Elgar)

Hannah L. Buxbaum

Indiana University Bloomington Maurer School of Law

Date Written: 2019

Improving Regulatory Impact Analysis: The Role of Congress and Courts, Part 1

From: Notice & Comment | A Blog from the Yale Journal on Regulation and the ABA Section of Administrative Law & Regulatory Practice

by Reeve Bull and Jerry Ellig

Part I—The Rise of Regulatory Impact Analysis

The concept of disciplining regulatory choices through the application of benefit-cost analysis to regulatory decisionmaking is largely an American innovation.  As Jim Tozzi has shown, the idea of economic assessment of proposed rules goes back to the Johnson Administration.  Presidents Carter and Reagan issued the executive orders that created the modern system of regulatory impact analyses (RIAs) and executive review within the Office of Information and Regulatory Affairs (OIRA), which has been reaffirmed by every subsequent administration.

Ill-Considered Tax Credit Regulation May Put the Squeeze on Charities, Taxpayers

From: Real Clear Policy

By Jerry Ellig

The White House Office of Information and Regulatory Affairs (OIRA) has started reviewing a draft of a final Internal Revenue Service regulation that seeks to prevent taxpayers from avoiding the cap on state and local tax deductions (colloquially known as the “SALT cap.”) Unfortunately, the version of the regulation the IRS proposed last August would also impose collateral damage on legitimate charities and taxpayers who are below the SALT cap. The administration can remedy those problems if it uses the OIRA review process to enforce some basic principles that have guided executive branch regulatory development for four decades.

Do the Results of the EU Better Regulation Program Match Its Ambitions?

Editor’s Note: “Strategic planning with political oversight halved the number of regulatory proposals….” Perhaps the Better Regulation program is a de facto regulatory budget under another name.

From: The Regulatory Review

Elizabeth Golberg

The Better Regulation program, built over the past two decades, has allowed the EU to regulate more effectively.