COVID-19 Viewpoints

On March 23, 2020 the SEC issued a statement warning about the risks of insider trading posed by the COVID-19 pandemic.

As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020.  The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously. 

This alert describes two types of relief loans available to small businesses suffering due to COVID-19: Paycheck Protection Program (PPP) loans and SBA EIDL loans.

As New York State announced that it had confirmed over 2,300 cases of the COVID-19 coronavirus, New York Governor Andrew Cuomo signed into law new requirements for New York State employees affected by the virus.  The new law was swiftly enacted in light of the urgent public health and economic crises facing the state, and goes into effect immediately.  It mandates that New York employers offer paid sick leave and job protections for workers quarantined as a result of the coronavirus outbreak.

On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health emergency began, the United States has experienced a shortage of masks, respirators, and other personal protective equipment (PPE) which are critically needed for health care workers caring for COVID-19 patients in all states. FDA previously created emergency use authorizations (EUAs) for NIOSH-approved disposable respirators for use in health care settings and imported non-NIOSH-approved disposable respirators, but the temporary enforcement policy represents an attempt to open the manufacturing, importation, and distribution flood gates to make more masks and respirators available as quickly as possible.

Congress has now passed the CORONAVIRUS AID, RELIEF AND ECONOMIC SECURITY ACT OR CARES ACT – Federal government’s Phase III response to the health and economic impacts related to the COVID-19 pandemic. President Trump has pledged to sign the Act into law immediately.

The COVID-19 global pandemic presents unique legal and practical challenges for companies across all industries, including with respect to privacy and cybersecurity risks and protections. Join Mintz, ML Strategies, and one of our industry partners, The Crypsis Group, for a webinar addressing these critical issues and the dynamic and evolving cybersecurity threats.

In response to the COVID-19 pandemic and the numerous travel bans and “shelter in place” orders which have been recently announced, the U.S. Citizenship and Immigration Services (USCIS) announced today that it will extend certain filing deadlines by 60 days.

In response to the nationwide COVID-19 emergency, state boards of pharmacy across the country are authorizing waivers of specific provisions of pharmacy laws and implementing policies to address potential staffing shortages and emergency dispensing of pharmaceuticals. Here's a high-level overview of the various actions being taken by state boards of pharmacy.

This alert discusses what companies outsourcing critical business process functions to India should do in light of the Indian government’s order that telecom, IT, and other technology companies should, as far as possible, work from home.

Adding another layer of complexity to sensitively marketing in the COVID-19 environment, YouTube announced on March 11 that it will permit certain creators to monetize (i.e., enable ads on) content relating to coronavirus.  Companies and brands should review their approach in this pandemic, including refining YouTube content exclusion parameters and policing their ad environments, if they do not wish to risk association with potentially undesirable videos. 

While many companies around the world are coping with a global pandemic, some are facing additional challenges in light of a looming deadline triggered by the California Consumer Privacy Act (“CCPA”).  Citing #covid19 concerns, a coalition of more than 60 such companies made a plea this week to California’s Attorney General Xavier Becerra (“AG”) to delay the AG’s enforcement of the CCPA.

Read about the SEC's new Guidance on Manual Signatures Required under Rule 302(b) of Regulation S-T as a Result of Coronavirus (COVID-19).

Read about the SEC’s extension of conditional relief from filing deadlines and mailing obligations as a result of COVID-19 to July 1, 2020.

Read about the SEC’s guidance on disclosures, including those related to COVID-19 and financial reporting issues, as well as on securities trading in light of the pandemic.

On March 23, 2020, the New York Senate proposed legislation that would forever waive rent payment obligations and mortgage payment obligations due from certain residential tenants and small business commercial tenants for 90 days in response to the COVID-19 pandemic.

Due to the national emergency declaration resulting from the COVID-19 pandemic, several states have closed and/or restricted services at DMV offices, precluding millions of people from applying for a REAL ID.  Accordingly, on March 26, 2020, Acting Secretary for the Department of Homeland Security (DHS), Chad Wolf, announced that the deadline for enforcement of the REAL ID Act would be extended by one year to October 1, 2021.

This alert reviews executive orders by New York Governor Cuomo and administrative orders by the New York State courts that have stayed residential and commercial evictions and foreclosures in New York.

As the COVID-19 pandemic continues to spread, so too have concerns about collaboration between competitors attempting to address unmet needs due to this national emergency. Shortages of medical supplies, personal protective equipment (PPE), and health care services pose questions of whether stakeholders can join forces in order to provide these much needed services and supplies.

As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician practitioners via telephone and that it will expedite pending enrollment applications submitted by all other providers and suppliers, including DMEPOS.  CMS made the announcement on March 13th and followed up with the publication of FAQs related to enrollment relief earlier this week.