COVID-19 Viewpoints

In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical laboratory testing in general during the COVID-19 public health emergency. We highlighted at the time an August 2020 Trump Administration order barring FDA from requiring premarket review for any LDT unless the agency goes through formal rulemaking procedures. We also speculated that although “the regulatory framework and policies surrounding LDTs will be a prominent topic of debate in 2021…there will be no quick resolution of these issues, either at a legislative or agency policy level, in the short term and that LDTs will likely remain in a gray area of FDA regulation and policy for the foreseeable future.”

In this episode of our Exclusive Rights podcast series, Mintz IP attorneys Daniel Weinger and Todd B. Buck, PhD, discuss the recent decision by the Biden Administration to signal US approval of a proposal to waive intellectual property rights related to COVID-19 vaccines currently under review at the World Trade Organization (WTO).

As the COVID-19 pandemic continues to upend our daily lives, the promise of a vaccine offers hope that life may, in the not-too-distant future, return to some version of normalcy. The path to getting a safe, accessible vaccine to market, however, presents a variety of its own challenges. As we’ve been exploring in our Bioethics in a Pandemic blog series, the pandemic has presented a host of bioethics issues pertinent to the vaccine development and distribution process. Mintz's Bridgette Keller recently shared her insights into how bioethics can (and should!) influence research and development at the M2D2 Challenge Awards. A video of her presentation is now available to view online.

Updated: The EEOC has provided employers with supplemental guidance on navigating the COVID-19 outbreak, addressing issues such as COVID-related harassment and screening employees who are reporting to work. The EEOC reminded employers that while the anti-discrimination laws, including the ADA and the Rehabilitation Act, continue to apply during the COVID-19 pandemic, these laws do not interfere with, or prevent employers from following, the guidelines and suggestions issued by the CDC or state and local public health authorities regarding COVID-19.

As we noted in our previous post, the Johns Hopkins University Center for Health Security (Center) has been hard at work studying and providing thought leadership regarding the COVID-19 pandemic from a variety of angles. The Center, in conjunction with Texas State University and the Working Group on Readying Populations for COVID-19 Vaccine, recently released a report exploring the public’s role in COVID-19 vaccination (Report). The Report provides recommendations to U.S. policymakers, practitioners, and other stakeholders about how to advance public understanding of, access to, and acceptance of vaccines that protect against COVID-19.

On May 18, 2020, the Baker-Polito Administration revealed its four-phased approach to reopening the Massachusetts economy and getting people back into the workplace in a safe manner, all while gradually easing social restrictions in order to minimize the negative health impacts of COVID-19.

Facing the many challenges posed by the COVID-19 pandemic, employers are considering their obligations to their workforce in the event of a reduction in force related to COVID-19 (“COVID-19”). This post provides an overview of an employer’s WARN Act obligations in the event a COVID-19-related closure or reduction in force.

In Part Seven of our Roadmap Series, we take a closer look at the impact of COVID-19 on employee mental and physical well-being, and what employers can do to assist their workforce.

As we continue to plan and prepare for the reopening of businesses, Part Six of our Roadmap series examines the when, what, where, and how of returning to work. Given the many considerations this process entails, we encourage employers to begin engaging with these issues now and to consult with counsel so that plans are in place and the groundwork is laid for the eventual reopening of the workplace, whenever that may be.

In Part 5 of our Roadmap Series, we take a closer look at COVID-19 screening and testing, including best practices and legal implications, as potential tools to maintain a safe workplace.

Given the challenges presented by COVID-19, many businesses must consider large-scale, transformational changes to their operations. As social distancing continues and safety concerns pervade the public consciousness, adjustments to the physical workspace and business travel practices will be necessary to reflect these new considerations. In Part 4 of our COVID-19 Roadmap Series, we outline important planning steps and concerns employers need to consider relating to physical workspaces and business travel.

In Part 3 of our Roadmap Series, we outline important guidance, procedures, and concerns employers need to consider to successfully and safely bring back employees to their worksite. As authorities begin reopening economies and traditional workplaces once again open for business, employers are facing difficult challenges regarding reorganizing and protecting their places of business. However, the exact measures appropriate and effective for each workspace will depend heavily on the outcome of a worksite risk assessment.

With the reopening of the economy on the horizon, employers are looking ahead to welcoming employees back to the traditional workplace. Business operations will look vastly different during and after the COVID-19 pandemic. In Part 2 of our Roadmap Series, we outline important operational planning steps and actions employers can take now to successfully and safely bring employees back to the workplace. Future posts in this series will address many of these issues more in-depth, so be sure to stay tuned.

New York State issued guidance on March 20th detailing answers to many frequently asked questions about the newly implemented COVID-19 quarantine leave law. We summarized the key components of the emergency law, which was enacted on March 18, 2020 and became effective immediately, in a previous blog post. In short, employers are immediately obligated to provide certain paid/unpaid leave (with duration and pay status varying based on the employer’s size), job protection, and expanded paid family leave and disability benefits to employees who are subject to a government-issued order of mandatory or precautionary quarantine or isolation due to COVID-19.

The U.S. Department of Labor (“DOL”) has released its 124-page temporary regulations of the Families First Coronavirus Response Act (“FFCRA”).

The rapid onset of the coronavirus crisis stripped many employers of the opportunity to prepare an orderly retreat from the physical workplace. While we do not know what the “normal” post-pandemic American workplace will look like, employers should plan now for this transformation.  The Mintz Employment, Labor and Benefits section is pleased to provide this Roadmap for the Post-Pandemic Workplace series that will provide guidance on critical issues employers should focus on as they prepare for what promises to be a very different workplace.

In response to the spread of COVID-19, on March 23, 2020, President Trump signed Executive Order 13910 (Order) to prevent the hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States. Through the Order, the President delegated his authority under the Defense Production Act of 1950, 50 U.S.C. § 4512 (Act) to the Secretary of Health and Human Services (HHS). The Order authorizes HHS to protect scarce and threatened health care and medical items by designating particular items as protected under the Act (Designated Items). Once an item is designated, the Act makes it a crime for any person to accumulate Designated Items: (i) in excess of the reasonable demands of business, personal, or home consumption; or (ii) for the purpose of resale at prices in excess of prevailing market prices. In this post, we discuss four things to know in connection with the Order.

The US Cybersecurity and Infrastructure Security Agency (CISA) of the Department of Homeland Security has issued a rare joint alert with the UK’s National Cyber Security Centre (NCSC) regarding coronavirus-related threats. The alert warns that cybercriminals and nation -state hackers are trying to take advantage of the pandemic for criminal gain.

In response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 25, 2020. In addition to the $2 trillion made available for medical countermeasure development, business relief, and other measures, the CARES Act amends the drug shortage reporting requirements and creates new requirements related to medical device shortages. With increased demand for products used to diagnose and treat COVID-19 patients and the stress placed on the manufacturing and delivery of vital products, having more information about drug, drug ingredient, and device shortages is becoming more critical.