K-12 Schools Returning In-Person During COVID-19

Posted on September 3, 2020Categories Uncategorized

During February 2020, COVID-19 hit the United States and disrupted many lives all throughout the country. Many states shut down most businesses, stores, and restaurants except for all essential services. By March, schools were forced to create unconventional forms of teaching methods for the remainder of the school year such as e-learning and sending students lesson packets for the week. As the school year approaches, many school districts are still determining their instruction mode for the upcoming school year. The Centers for Disease Control and Prevention (CDC) provided guidelines to reopening schools and advised school districts to work closely with local and state health officials to determine the best practices for reopening.
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Voting in the 2020 Election

Posted on August 24, 2020Categories Uncategorized

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.
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Pre-Approval Access and Pathways to Investigational Drugs

Posted on August 13, 2020Categories Drugs & Devices, Uncategorized

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.
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Welp, The New Title IX Regulations Are Here

Posted on August 13, 2020Categories Uncategorized

Earlier this May, Betsy DeVos, the US Secretary of Education, announced the new Title IX regulations that were to be implemented by the beginning of August. DeVos argued that the regulations did not provide due process to students accused of sexual assault. Victim advocacy groups contended that her amended rules discourage victims from reporting their sexual assaults or harassment. Victim advocacy groups also state that schools are unprepared to implement many of the changes to Title IX. Students, women’s rights organizations and educational groups have come together and have filed a law suit to stop the new relegations from taking effect. This is only one of many suits that have been filed to stop the regulations. When people think of sexual assault on college campuses, many people automatically think of Title IX. However, many states around the country have their own state laws that also regulate how colleges and universities are supposed to handle sexual assault and harassment cases. These state laws will also have to be amended to follow the new Title IX regulations.
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Title IX Reform

Posted on August 4, 2020Categories Athletic Regulation

On May 6, 2020, Secretary Betsy Devos, through the Department of Education (the “Department”) issued the new Title IX regulations (the Final Rule) scheduled to take effect August 14, 2020. The U.S. Department of Education’s Office for Civil Rights (OCR) enforces Title IX of the Education Amendments of 1972. The statute states that “No person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving Federal financial assistance”, yet it does not define sexual harassment. The Final Rule is heavily contested due to its demanding provisions and implementation period during the pandemic.
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New Title IX Rules for Schools

Posted on August 3, 2020Categories Uncategorized

On May 19, 2020, the Department of Education published a final Title IX regulation that changes the rights and responsibilities for schools, complainants, and respondents. In summary, these regulations respond to the need to provide a prompt and just response to individuals who have suffered sexual harassment and provide due process for an alleged perpetrator. These changes create a standard grievance process, define conduct that constitutes sexual harassment, outline conditions that activate a school’s obligation to respond, impose a minimum standard of school response, and establish procedural due process protections.
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Establishing Expanded Use Programs

Posted on July 17, 2020Categories Drugs & Devices

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.
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Clinical Trials and Human Participants

Posted on July 16, 2020Categories Uncategorized

This past spring the world locked down. Stores were closed, everyone was required to work from home, and masks became the latest fashion trend. This shift occurred because a virus, Covid-19, began making its way around the world. It has been about 4 months since our society locked down for the protection of its people and while it is slowly opening back up there are fears that without a vaccine or cure for Covid-19 it is going to keep spreading and we are going to have to remained locked down. Many pharmaceutical companies are working night and day to create a vaccine that can be widely distributed to help stop the spread of Covid-19. A drug that is for humans needs to be tested on humans to ensure it works before it can be approved and sold.
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Illinois Unemployment Benefits for Academic Personnel

Posted on June 29, 2020Categories Uncategorized

During the expedited legislative session on May 20-24, the Illinois General Assembly passed HB 2455 which was signed into law as Public Act 101-633 on June 5, 2020. While well-intentioned, this Act could create a huge liability for school districts depending on how the Illinois Department of Employment Security (“IDES”) interprets the law. School districts are already facing an uncertain financial future and this law is adds more uncertainty and possibly more financial insecurity.
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New Rules for Illinois Firearms Dealers

Posted on June 26, 2020Categories The Art of Compliance, Uncategorized

The Firearms Dealers License Certification Act (also known as the Combating Illegal Gun Trafficking Act) was signed into law on January 18, 2019 and requires all Federal Firearms License (FFL) dealers engaged in the business of transferring firearms to have their FFL certified by the Illinois State Police. Nevertheless, many areas of the regulations remain in dispute and strong opposition has led to the delay of dates for required compliance. The Act is also being challenged by the Illinois State Rifle Association and a number of gun dealers in Illinois who deem that the Act is an unconstitutional infringement on their right to keep and bear arms.
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