Administrative

By Ben Rubin on June 21, 2019

For over three decades, most property owners have been relegated to state courts when pursuing a takings claim against a state or local agency. In a 5-4 decision issued this week, the U.S. Supreme Court reversed itself and opened the door to the federal courthouse, allowing property owners to bypass the state courts and file a Fifth Amendment takings claim in federal court in the first instance. Knick v. Township of Scott, 588 U.S. __ (June…

Gulf States Gaming Law

Mississippi Gaming Commission Posts Meeting Minutes for June 2019

By Tommy Shepherd on June 21, 2019

The minutes for the Mississippi Gaming Commission’s meeting held on June 20, 2019, can be reviewed by clicking here.…

Gulf States Gaming Law

Update on Sports Wagering in Louisiana

By J. Kelly Duncan, Tommy Shepherd & Chris Ulfers on June 21, 2019

We write with an update on the status of sports wagering in Louisiana. In our May 2019 article titled “Sports Wagering in Louisiana Might Be on the Horizon,” we provided an overview of Senate Bill 153, sponsored by Senator Danny Martiny (R-Metairie), and its efforts to legalize sports wagering in Louisiana. As of May 22, the date on which our prior article was published, the Senate had passed Senate Bill 153 by a 24-15…

FCA Update

DOJ Preserves Its Options in Cooperation Credit Guidance

By Tony Maida & Rebecca C. Martin on June 21, 2019

Last month, the Civil Division of the Department of Justice (DOJ) announced the release of formal guidance to DOJ civil attorneys on how to award “cooperation credit” to defendants who cooperate with the Department during a False Claims Act (FCA) investigation. The formal policy, added to the Justice Manual Section 4-4.112, identifies the type of cooperation eligible for credit. As announced by Assistance Attorney General Jody Hunt, DOJ believes the guidance reflects “important steps…

Focus on Regulation

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

By Lynn Mehler & Yetunde Oni on June 21, 2019

Agency seeks input on “comparative advantage” requirement for new opioids Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing whether a new opioid drug application meets the statutory standard for approval. FDA also announced it will hold a public meeting on September 17 to discuss this benefit-risk assessment…

Inside Government Contracts

NIST Announces and Seeks Public Comment on 800-171 Update and Related Documents

By Susan B. Cassidy, Ashden Fein, Moriah Daugherty & Melinda Lewis on June 20, 2019

On June 19, 2019, the National Institute of Standards and Technology (“NIST”) announced the long-awaited update to Special Publication (“SP”) 800-171 Rev. 1, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations, which includes three separate but related documents.…

The Antitrust Attorney Blog

Why You Should Consider Filing an Amicus Brief in an Appellate Case

By Bona Law PC on June 19, 2019

Author: Jarod Bona An amicus curiae brief is filed by a non-party—usually in an appellate court like the US Supreme Court—that seeks to educate the court by offering facts, analysis, or a perspective that the party briefing doesn’t present. The term amicus curiae means “friend of the court,” and that is exactly what the parties that file these briefs are. They aren’t objective, but they are—without pay—helping out the court, like a friend might.…

Inside Political Law

In Major Blow To Its Opponents, SEC Pay-to-Play Rule Survives D.C. Circuit Challenge

By Zachary G. Parks on June 19, 2019

The U.S. Court of Appeals for the D.C. Circuit yesterday issued a long-awaited opinion upholding, on the merits, a recent update to the SEC’s pay-to-play rule. While the case involved only a narrow piece of the rule, the decision’s logic is worded more broadly and could apply to the SEC rule as a whole, making future challenges to the rule much more difficult, at least in the D.C. Circuit. For years, opponents of the SEC…

Food & Drug Law Access

Court Rules Indian Tribe Cannot Regulate Hemp Production (Yet)

By Kristi Wolff & Bez Stern on June 19, 2019

As we’ve written about several times, the 2018 Farm Bill legalized hemp but specified that it must be done pursuant to a state or tribal plan, known as a 279B plan. Such a plan is not effective until approved by the Secretary of Agriculture. The USDA has not yet issued its own hemp plan, and has stated that it will not approve any state or Indian tribe’s plan until after it issues its own.…

Focus on Regulation

The European Commission releases an updated Borderline Manual for medical devices

By Fabien Roy & Alexander Wenzel on June 19, 2019

Introduction The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).…