Monthly Archives: June 2017

FDA Advisory Committees and Industry-Funded Patient Advocacy

by Patti Zettler — Friday, June 23, 2017@pzettler

Cross-posted on Objective Intent and Stanford’s Law and the Biosciences Blog. Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry […]

“Passing the Buck” in Agency Adjudication, by Bijal Shah

by Guest Blogger — Friday, June 23, 2017

Agencies often share their power with one another—the operative word being ‘share.’ For instance, they engage in “joint rulemaking” with other agencies on the basis of shared statutory authority. They also participate in “coordinated interagency adjudication,” in which they subdelegate portions of their power to adjudicate administrative claims or otherwise share the responsibility of furthering an adjudication process on […]

Mortazavi on Computer Analysis of Rulemaking Comments (AdLaw Bridge Series)

by Emily Bremer — Friday, June 23, 2017@emilysbremer

Technology has promised big benefits for public participation in notice-and comment rulemaking, but it has also presented new challenges for agencies.  For example, as the number of rulemaking comments has increased, so too has the administrative burden of reviewing those comments.  Can an agency use computer software to help ease this burden while still discharging its obligations under the APA?  Melissa Mortazavi addresses […]

“Not a One-Person Show”: Trump as Administrator-in-Chief of the Immigration Bureaucracy, by Ming H. Chen

by Guest Blogger — Wednesday, June 21, 2017

[6/28/2017 Update: When the travel ban is heard in the Supreme Court’s October 2017 term, the core issue will be the President’s leadership of the executive branch, an issue mired in administrative law as much as immigration and Constitutional law.] Recent events paint a portrait of what President Trump is like as a boss. It […]

The Challenges of Performance-Based Regulation: Lessons from Two Diesel Emissions Scandals, by Cary Coglianese & Jennifer Nash

by Guest Blogger — Tuesday, June 20, 2017

When the Volkswagen diesel emissions scandal erupted recently—resulting in a precipitous drop in the company’s stock price, the resignation of its CEO, a $14.7 billion judgment against the company, and extensive environmental harm—we were reminded of an eerily similar environmental scandal from about 20 years ago. In 1998, the US Environmental Protection Agency (EPA) brought […]

Frozen Charters, by Scott Hirst

by Guest Blogger — Monday, June 19, 2017

In 2012, the New York Stock Exchange changed its policies to prevent brokers from voting uninstructed shares on corporate governance proposals. Although the change was intended to protect investors and improve corporate governance, it has had the opposite effect: a significant number of U.S. public companies are no longer able to amend important parts of […]

Supporting FDA Product Reviews with User Fees Alone

by Erika Lietzan — Saturday, June 17, 2017@lietzan

Cross Posted on Objective Intent. Budget documents released by the White House and FDA in May suggest the Administration intends to restructure medical product user fees, so that a greater percentage of the agency’s work is fully user fee funded.  The Secretary’s May 15 letter, explaining the President’s earlier Budget Blueprint, suggests the goal is […]

Chevron’s Political Dynamics (AdLaw Bridge Series)

by Chris Walker — Friday, June 16, 2017@chris_j_walker

Last July Kent Barnett and I posted a draft of the first paper from our years-long coding project of every publish circuit court decision over an eleven-year period that dealt with Chevron deference. That paper is forthcoming in the Michigan Law Review later this year. I blogged about it here, and Dick Pierce reviewed it over […]