Month:

August 2020

The Road to Regulation

The implications arising from fuel consumption and greenhouse gas emissions standards set by the Environmental Protection Agency (“EPA”) and the Department of Transportation (“DOT”) in the early 2010s spelled out a cautionary tale for automotive manufacturers wondering how to comply with increasingly strict regulations.

DEA Proposes New Rules Aimed to Increase Federal Cannabis Research

On Monday March 24, the Drug Enforcement Agency (DEA) proposed amending the rules under the Controlled Substance Act to expand cannabis research in accordance with a 2016 policy statement. Among these changes includes directing the DEA to take title and physical possession of cannabis plants and increasing the number of entities permitted to manufacture cannabis for research.

Regulatory Shortcuts Taken in Creation of 737 Max Jets

Boeing’s fleet of 737 Max jets remain grounded in the wake of two crashes that occurred shortly after takeoff and within five months of each other. Both crashes killed all passengers on board, a total of 346 people, and the jets’ black box data recorders have revealed many similarities between the two incidents. Both jets were equipped with Boeing’s newly implemented stall-prevention software called the Maneuvering Characteristics Augmentation System (MCAS). The system automatically adjusts the pitch of the aircraft, but it malfunctioned in both crashes when MCAS seized control from the pilots and plunged the jets into the ground. The Federal Aviation Administration (FAA) has not yet announced when these jets will be allowed to fly again, although test flights have recently been conducted.

NCAA and Agent Representation: The Policy Implications of Agent’s Roles Pertaining to Proposed Name, Image, and Likeness Legislation

With changes to the regulations of the National Collegiate Athletic Association (NCAA) student-athlete model looming overhead, the role of athlete representation is significant in the conversation relating to name, image, and likeness (NIL) of the student athlete. The NCAA has a long-standing “no-agent” rule that forbids student-athletes from being represented by an agent or organization in the marketing of his or her athletic ability until after the completion of their last intercollegiate contest. The NCAA determines a student-athlete’s eligibility based partly on their amateurism status, a term which is not expressly defined by the NCAA, although guided by several factors. Among those factors that would remove an athlete’s eligibility from NCAA competition, is a binding agreement to be represented by an agent at any time before or during a student-athletes collegiate career, however, there are a few exceptions to this factor.The underlying purpose of the “no-agent” rule is to protect student athletes from exploitation in the open market. To further regulate potential issues, the NCAA adopted the Uniform Athlete Agents Act, which effectively criminalizes contact between agents and athletes before the athletes completion of their last intercollegiate contest. 

Corporate Cybersecurity: Managing Data in the Era of Cyberattacks

Within the last decade, data has surpassed oil as the world’s most valuable commodity. Earlier this year the Securities and Exchange Commission (SEC) released its observations made during audits that detailed the methods used by corporations to secure their data. This included the kinds of cybersecurity practices employed by companies as well as advice on how to better deal with sensitive data and protect against potential cyberattacks. The SEC’s observations coincide with a recent announcement from the National Security Agency (NSA) that showcases an increased concern surrounding cybersecurity in the corporate world.

The Future of Police Accountability in Chicago

In the wake of mass protests across the country, many cities are grappling with how to hold their police accountable.  In Chicago, the Committee on Public Safety has been debating two proposals, the Grassroots Alliance for Police Accountability (GAPA) and the Civilian Police Accountability Council (CPAC), for the past few months. Both ordinances would supersede the Civilian Office of Police Accountability (COPA) with a fully elected board of community members. The key difference between the two proposals is that CPAC would be independent of the mayor’s office and would have complete hiring and firing control of Chicago Police Department (CPD) officers and the police superintendent, while the GAPA ordinance would only give the board power to make recommendations to the mayor and the police superintendent. The Chicago City Council will debate and vote on these ordinances in the coming months.

Bipartisan Bill Seeks to Force Chinese Companies to Play by the Rules

On Wednesday May 20, the Senate unanimously passed legislation aimed to curb the ability of Chinese companies to avoid audit requirements. The bill was introduced by Republican Senator John Kennedy of Louisiana and Democratic Senator Chris Van Hollen of Maryland. Senator Kennedy provided the following comment in a press release announcing the legislation: “It’s asinine that we’re giving Chinese companies the opportunity to exploit hardworking Americans—people who put their retirement and college savings in our exchanges—because we don’t insist on examining their books. I hope my colleagues in the House will immediately send this bill to the President’s desk so we can protect Americans and their savings.”

Income Share Agreements; a Solution to Increasing Educational Debt in America or Just Another Student Loan?

In times of economic recession, Americans historically have sought additional education to mitigate minimal employment prospects and retrain for an evolving job market. Coding bootcamps may be especially attractive in the era of COVID as they provide vocational training in a growing field and many programs are offered remotely by design. These programs may become even more enticing because of a new financing instrument called an income share agreement (“ISA”).

Voting in the 2020 Election

Most United States citizens have certain expectations when they go to their polling station; voters expect to stand in a line, to be handed a ballot by an official, or to vote on a touch screen system. Yet, amid COVID-19, for many Americans, going to a polling station presents too many opportunities for the transmission of the virus. As a result of the danger of voting in-person and the desire to vote by mail, it is projected that the United States Postal Services (hereinafter “USPS”) will deliver an unprecedented number of mail-in ballots.

Pre-Approval Access and Pathways to Investigational Drugs

The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.