Category:

Journal of Regulatory Compliance

The NEPA: Environmental Impact Statements, Compliance, and an Impending Threat to Environmental Regulation

On March 25, 2020, a judge for the United States District Court in the District of Columbia held that the Army Corp of Engineers (hereinafter the Corp) failed to comply with the standards of the National Environmental Policy Act (hereinafter “the Act”) by failing to prepare an Environmental Impact Statement (EIS) before deciding to approve federal permits for construction of a portion of the Dakota Access Pipeline which ran under the Mississippi River.  The ruling came four years after the Standing Rock Sioux Tribe brought the original action in 2016.  The Act is meant to ensure the public that agencies have considered the environmental consequences of a potential project before going forward with it, and so requires agencies to consider any and every significant environmental impact that could result from the project through completion of an Environmental Assessment, and, in some cases, an Environmental Impact Statement (EIS).

Financial Regulation During COVID-19

Coronavirus (COVID-19) has shaken the world economy, not the least of which the financial industry.  As the financial industry has adapted to work-from-home life under the coronavirus pandemic, industry regulators such as the SEC and the Financial Industry Regulatory Authority (FINRA) have been forced to adapt rules to changing circumstances and shift their enforcement priorities to pandemic related fraud. 

Standardization and Cooperation Needed to Fix Crumbling Infrastructure

Northeastern Michigan was already facing a pandemic on May 19 when a breach in the Edenville dam forced 10,000 residents to flee their homes in the face of deadly floodwater. The dam failure elevates the need for state and federal regulators to standardize regulations and collaborate on their enforcement to prevent similar incidents. 

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. 

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.

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.

Establishing Expanded Use Programs

The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.