On December 22, 2018, for the third time in a year, the United States government shut down. Almost two years into his presidency, President Trump, feeling pressure to accomplish one of his many promises from the campaign trail, requested $5.7 billionfrom Congress to fund his proposed wall at the border of the United States and Mexico. Following negotiation efforts by Senate Democrats, the standoff between the President and the Senate ended in a financial default, triggering a partial shutdown. The shutdown became the longest in U.S. history on January 19, 2019, beating the previous 21-day recordset by the 1995-1996 shutdown. The shutdown left an estimated 380,000 government employeeslocked out of work without pay and an even greater 420,000 employees working for no compensation at all, including employees of the IRS. With one of the United States’ most important governmental bodies being almost completely stalled by a lapse in funding, it begs the question: what happens to taxes during a shutdown?
Regulatory compliance requires investment, but it can also mean opportunity. The level of investment looks different depending on the industry. One consistency covering all industries impacted by regulation is the potential benefit resulting from relationships with compliance officers and regulatory officials. Embracing compliance means embracing the relationships that follow.
Arizona and Idaho are the most recent in a long line of states declining to adopt the American Bar Association’s (ABA) new Model Rule 8.4(g), which is being called the “anti-discrimination” rule. This rule was adopted by the ABA to specifically address harassment and discrimination based on race, religion, sex, disability, and LGBTQ status in all conduct related to the practice of law. However, because of the broad construction and application of the rule, many states and attorneys have concerns that compliance with this anti-discrimination rule will infringe on their First Amendment rights of freedom of speech and religion.
Last year the #MeToo movement swept across the country, sparking national attention and debate. Fast forward 11 months and we still grapple with breaking news which exposes the next unsuspecting top executive of workplace misconduct. Victims are finally breaking their silence, leading corporations to reassess corporate culture. In this modern age, compliance is not enough. Corporations might need to reconsider decades old written policies and training programs to ensure safety, success, and growth in the workplace.
In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.
“What is the Future of Compliance in Enterprise Risk Management?” February 15, 2019 Loyola University Chicago School of Law Philip H. Corboy Law Center Power Rogers & Smith Ceremonial Courtroom 25 E. Pearson Street Call for Papers The Center for Compliance Studies at Loyola University Chicago School of Law and The Loyola Journal of Regulatory …