COVID-19 Viewpoints

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.

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.

Read about SEC C&DIs that provide guidance on its COVID-19 Order, which gives certain issuers relief from deadlines as a result of the coronavirus pandemic.

In part one of our two part series we discussed a number of the menu options that may be available to commercial landlords and tenants to help them protect their businesses during the COVID-19 pandemic, but few of those options we discussed in part one are without their own unique set of hurdles.

One important question the Families First Coronavirus Response Act (“FFCRA”) and other recent legislative changes raise for employers is how to track and account for employee leaves. While most employers already have systems in place to track employee absences, employers should review their pre-pandemic recordkeeping to account for the “new normal” and new laws. These updates are not only to account for the FFCRA and any other federal or state laws – including the potential application for tax credits – but also, just as importantly, in anticipation of the return to work of the employer’s workforce.

As the COVID-19 outbreak continues to disrupt normal workplace operations, an increasing number of employers are facing the reality of employees testing positive for the virus – particularly in industries like healthcare, construction, transportation, or retail, where workers cannot necessarily telecommute. Employees may also report to work sick, or become sick at work, and show COVID-19 symptoms. Even though employers may be hoping for the best, it is best to have a plan for the worst. Employers should have clear plans and procedures in place to address confirmed or presumptive COVID-19 cases in the workplace, which will enable employers to take swift, appropriate actions to minimize risk for their employees and operations. The following are guidelines for steps to take in addressing these situations:

In accordance with Governor Cuomo’s Executive Order 202.6 issued on March 7, 2020, and the Guidance on Executive Order 202.6 issued on March 27, 2020, all non-essential construction is suspended in the State of New York.

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.

On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public health emergency. The revisions address two key omissions from the initial policy, which was released on March 25, 2020 and which we summarized in a prior blog post. Specifically, the agency has now provided guidance on: (1) the importation of respirators not approved by the National Institute for Occupational Safety and Health (NIOSH) and (2) the manufacture and distribution of face shields. FDA also added a question and answer about respirators manufactured in China to the KN95 air filtering standard (the Chinese equivalent of the U.S. government’s N95 standard) to its FAQ page on the personal protective equipment shortage and issued an emergency use authorization for non-NIOSH-approved respirators made in China.

This advisory provides a drafting guide for purchase and sale agreements in the post–COVID-19 era.

On March 16th, Attorney General William Barr issued a memorandum to all United States Attorneys directing each U.S. Attorney’s Office (USAO) to “prioritize the detection, investigation, and prosecution of all criminal conduct related to the current pandemic,” noting that “the pandemic is dangerous enough without wrongdoers seeking to profit from public panic.”  It appears that USAOs have wasted no time in prioritizing such cases, as the owner of a Georgia-based marketing company that generated leads for medical-testing companies was arrested earlier this week and charged with conspiracy to commit health care fraud and conspiracy to violate the Anti-Kickback Statute.

Over the past several weeks, the Firm has received a number inquiries from clients (on both coasts) who are interested in manufacturing or selling test kits, respirators, masks, and other PPE in response to the COVID-19 pandemic, with respect to potential liability risks associated with such activities.

The interruption to business-as-usual in the commercial real estate industry brought about by the COVID-19 pandemic has been unprecedented and, while hopefully only temporary, the full extent of the impact may not be entirely understood for some time to come. Below, we explore just some of the options both landlords and tenants will want to consider when looking to answer that question.

On March 24, we posted a summary of California’s “shelter in place” order issued on March 16, 2020, and in particular discussed the relationship between it and the Bay Area county orders already in effect at the time. As expected, the Bay Area counties have since lengthened the duration of their shelter in place orders to May 3, 2020 (except Solano County, which extended to April 30) and implemented tighter restrictions.

We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public health emergency. At the same time, however, the agency has also been taking various steps to help medical product sponsors and consumer product manufacturers and distributors prioritize their ongoing regulatory compliance activities during this challenging period for business-as-usual.

As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.

As we reported here, FINRA issued guidance to member firms and their associated persons earlier this month to remain “vigilant in their surveillance against cyber threats and take steps to reduce the risk of cyber events.”

In response to the COVID-19 outbreak, the United States, like many states has reacted by providing certain multifamily landlord and tenants with economic benefits during this unprecedented global pandemic. On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). Section 4023 of the CARES Act contains several provisions that assist borrowers of federally backed multifamily mortgage loans due to the COVID-19 outbreak.

In a Statement on April 2, the Chairman of the Securities and Exchange Commission (SEC), Jay Clayton, announced that the June 30, 2020 timeline for implementation of Regulation Best Interest (“Reg. BI”) will remain.

Back in March, we wrote a blog post regarding the FTC and DOJ’s joint statement on antitrust guidance for COVID-19 public health efforts. As part of the press release, the Agencies announced that companies could request an expedited staff opinion on requests for review of collaborative COVID-19-related business efforts. The Agencies would endeavor to respond to all requests within seven business days. On Saturday, the DOJ issued its first business review letter, allowing to come to fruition a joint effort by McKesson, Owens & Minor, Cardinal Health, Medline, and Henry Schein (the “Medical Supplies Distributors”) to expedite and increase manufacturing, sourcing, and distribution of personal-protective equipment (PPE) and COVID-19-related medication.