COVID-19 Viewpoints

Read about the SEC’s amendment to its capital raising rules for Regulation Crowdfunding to promote capital formation and expand investment opportunities.

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the quality of different subsets of tests. Since then, there have been some important policy developments affecting diagnostic and antibody testing. There also has been significant growth in the number of tests authorized by the Food and Drug Administration for point-of-care uses in various patient settings such as clinics, emergency departments, and physician offices. Read on for an update about these developments.

The New York Department of Taxation and Finance has finally provided guidance regarding telecommuting tax liability for nonresident employees working outside of New York because of the COVID-19 pandemic. In short: employees telecommuting because of COVID-19 will generally still be required to pay New York taxes on income they earn.

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational vaccines for COVID-19. This guidance was the subject of intense political debate among the White House, FDA, and other public health officials given the urgent need for a safe and effective vaccine.

Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available. The nuts and bolts of the Final Framework remain largely the same as the Draft Framework we covered previously in our Bioethics Blog Series. After a quick review of the Allocation Phases here, we explore a few areas in the Final Framework the Committee expanded on and responded to stakeholder comments.

Months into the COVID-19 pandemic, many employer telecommuting arrangements remain in place, with several large corporations opting to extend these arrangements well into 2021. The benefits of such arrangements have been clear for many employers during the pandemic, including that they permit continued productivity while keeping employees safe. However, the longer that employees remain out of the office, the more telecommuting-related issues arise, including with respect to taxation of employee income and leave requirements, which we discuss below.

The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating COVID-19 symptoms. Although the regulatory action was announced in the FDA’s daily pandemic update on October 2, 2020, the warning letter issued by the Office of Prescription Drug Promotion (OPDP) is dated September 22, 2020. From our perspective, this public FDA action is notable for two distinct policy reasons.

As predicted, the Department of Justice (DOJ) and other enforcement agencies have acted quickly to bring substantial criminal enforcement actions for fraud against the Paycheck Protection Program (PPP). Acting Assistant Attorney General (AAG) Brian Rabbitt announced recently that the DOJ’s Criminal Division reached the important milestone that day of criminally charging more than 50 individuals for alleged fraud committed to obtain PPP funds.

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.

References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private effort to accelerate COVID-19 countermeasures, such as the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. OWS has ambitious goals. It intends to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 19, 2021. Here, we provide a brief overview of OWS, its current progress, and relevant ethical considerations.

The Department of Labor has again updated its guidance regarding the Families First Coronavirus Response Act ("FFCRA"). 
Below we summarize the DOL’s interpretative guidance, and note in bold where the DOL has either reaffirmed or changed its guidance in light of the federal court decision.  As a reminder, the law expires on December 31, 2020. 

After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine development process, including clinical trials. As a first step, we provide a very brief introduction on how vaccines are developed and tested prior to approval and release.

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.

The reopening of schools during the COVID-19 pandemic continues to present challenges for working parents and the businesses that employ them. Not surprisingly, a one-size-fits-all approach for employers to appropriately manage working parents is likely difficult, if not impossible, to craft. In this post, we highlight some of the risks employers may face while offering some guidance regarding best practices to address these risks.

As you know, the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) was released earlier this week, and we are highlighting its major sections as stakeholders prepare to submit comments by Friday, September 4th. Building on the lessons learned from past allocation frameworks, this post highlights the key provisions of the Draft Framework.

Continuing with our review of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”), this post highlights a number of uncertainties that will be faced in implementing the proposed allocation. For additional background on the Draft Framework, please see our earlier posts in the Bioethics in a Pandemic series. The final chapter of the committee’s discussion draft identifies specific uncertainties that could present obstacles to the proposed allocation plan’s implementation. Ultimately, a vaccine allocation framework must remain flexible and adaptive when faced with updated scientific evidence and developments like those listed above. These considerations, as well as the public comments, will continue to be inform the development of the framework.

On September 3, 2020, the FCC released a Public Notice providing additional guidance to prospective applicants who may wish to seek funding under the FCC’s Connected Care Pilot Program for connected care services.  As we previously reported, that program will make $100 million available over three years to help defray health care providers’ costs of providing connected care services, with a particular emphasis on supporting those services for low-income Americans and veterans.

Earlier this week, a committee of the National Academies sponsored by the CDC and NIH released its Draft Framework for Equitable Allocation of COVID-19 Vaccine. This Draft Framework builds on the successes and challenges of past vaccine allocation frameworks, as well as current frameworks for allocating scarce COVID-19 resources. This blog reviews these past frameworks that laid the foundation for the committee to develop its decision-making framework.

The Johns Hopkins University Center for Health Security (the “Center”) has been providing thought leadership related to the novel coronavirus and the COVID-19 pandemic since the beginning of the year. Two of the Center’s recent reports relate directly to our discussion on vaccine distribution.  The first is an interim framework for COVID-19 vaccine allocation and distribution (the “Report”), and the second focuses on the public’s role in COVID-19 vaccination. Here, we provide a high-level overview of the first report. We’ll dive into the second report in a separate blog post.

As we continue to discuss the ethical considerations related to the distribution of a safe and effective coronavirus vaccine, it is important to consider lessons learned from other pandemics. Though the particular facts of past pandemics of course differ from those of COVID-19, the goal of public health has always been to promote and protect the health and well-being of a population. Similarly, the ethical distribution of resources amid any pandemic is supported by the balance and tension among the four ethics principles: autonomy, justice, beneficence, and nonmaleficence. Here, we look at lessens learned from the poliovirus, ebolavirus, and 2009 H1N1 pandemics, as well as the National Pandemic Strategy related to vaccine distribution.