COVID-19 Report for Life Sciences and Health Care Companies (October 2021)

Wednesday, 27 October 2021

• This past week, the U.S. Food and Drug Administration (FDA) authorized the tenth over-the-counter (OTC) COVID-19 test, reissued the emergency use authorization (EUA) for another OTC COVID-19 test, and updated the EUA templates for test developers seeking an EUA for OTC tests. The EUA is for the Celltrion Diatrust COVID-19 Ag Home Test, an OTC COVID-19 diagnostic antigen test. FDA has reissued the EUA for the Quidel QuickVue At-Home OTC COVID-19 Test to authorize use by people with COVID-19 symptoms as a single test without a health care provider prescription. Last, FDA also updated the test labeling recommendations for test instructions and product labeling in the EUA templates for test developers to support authorization of more COVID-19 tests for use without a health care provider prescription. The updated templates are the Molecular and Antigen Home Use Test Template and the Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing.

• In addition, last week, FDA amended the EUAs for COVID-19 vaccines to allow for the use of a single booster dose as follows:

  • The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals 65 years of age and older, and 18 through 64 years of age at high risk of severe COVID-19 or with frequent institutional or occupational exposure to SARS-CoV-2;

  • The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older;

  • The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine; and

  • To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. (Authored by Randy Prebula)

Wednesday, 20 October 2021

• Last week, the U.S. Food and Drug Agency (FDA) posted information about an assessment of the Emergency Use Authorization (EUA) process implemented to help authorize COVID-19 tests during the public health emergency. This assessment focuses on how FDA's Center for Devices and Radiological Health (CDRH) prioritized processing of EUA requests, review times, accuracy & reliability of COVID-19 tests, a comparison to prior public health emergencies, and requestors’ perspectives. The web posting includes Booz Allen Hamilton’s EUA Assessment and recommendations and CDRH’s perspectives and next steps. (Authored by Randy Prebula)

• The FDA issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and risk management options factor into FDA’s regulatory decisions related to drugs and biological products, from premarket approval through the postmarket setting. The guidance highlights the agency’s ongoing effort to advance patient-focused drug development (PFDD), addressing the need to better enable patients to provide meaningful input into development through “patient experience data.” The guidance notes that a higher degree of uncertainty is common in drug development programs for rare diseases, where the prevalence of disease, and consequent limitations of study size, can limit the precision of safety and efficacy characterizations. Thus, as noted in the guidance, FDA “often exercises greater regulatory flexibility in these cases." Separately, HHS and FDA have also offered drug sponsors greater flexibility on human subjects protection regulations during the COVID-19 pandemic. FDA is accepting comments on the guidance through 29 November, and we have analyzed the new guidance online here. (Authored by Lowell Zeta)

• More than a year on from the emergence of COVID-19, the European insurance industry is continuing to feel the effects of the pandemic. The impact on the market has been deep and is likely to be lasting, even once the immediate threat from the pandemic subsides. The COVID-19 experience has posed difficult questions for the insurance industry, such as: What is the role of (private sector) insurance in the face of a systemic risk event where losses do not respect any geographical boundaries and permeate all aspects of commercial and private life? What does the COVID-19 experience tell us about how the insurance industry might best respond to the climate threat or cyber risks? What changes do we need to see in the market to adapt for the future? Our European team has analyzed these questions and more in a new piece online here. (Authored by Dr. Sebastien Gros)

Wednesday, 13 October 2021

• Yesterday, the U.S. Food and Drug Administration (FDA) announced that it intends to withdraw, effective 31 Dec. 2021, guidance documents originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency. Companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products as of 31 December.  Also, last week, FDA posted updated templates for COVID-19 tests intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes.  (Authored by Randy Prebula)

• On 5 October 2021, the Office of the United States Trade Representative (USTR) issued a Notice and Request for Comments to consider the reinstatement of expired product exclusions from the China Section 301 tariffs. The USTR process, which could impact 549 lapsed tariff exclusions, will start on 12 October and will last until 1 December 2021. All of these 549 exclusions have expired, with the exception of certain exclusions related to the COVID-19 pandemic. Exclusions for most of these products expired by December 31, 2020, and the remainder on March 25 and April 18, 2021. Companies with lapsed exclusions to the China Section 301 tariffs should promptly contact the Hogan Lovells trade team to assess whether their imports from China are eligible for renewed exclusion from the 25% Section 301 tariffs. Read more online here. (Authored by Deen Kaplan)

• Brazil is currently experiencing an unprecedented surge in the number of initial public offerings (IPOs) registered with the Brazilian Securities Commission ("Comissão de Valores Mobiliários," or the "CVM"). This recent wave of CVM registered equity offerings has been ongoing for the last two years and the market continues to show signs of high levels of activity. After a long period of reduced activity, the Brazilian capital markets saw over 20 companies register IPOs in 2020 and over 35 IPOs have been completed in 2021 as of today. The current wave of IPO activity can be primarily explained by the excess of liquidity in global markets as a result of monetary and fiscal measures implemented by governments and central banks throughout the world to mitigate the effects of the recent global recession and as well as the impact caused by the COVID-19 pandemic. Online here we have analyzed the reasons for, lessons learned from, and what to expect from the Brazilian IPO Surge. (Authored by Isabel da Costa Carvalho)

Wednesday, 6 October 2021

• Last week, the U.S. Food and Drug Administration (FDA) authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at the Emergent facility. To date, a total of nine batches of Janssen COVID-19 vaccine that were manufactured at the Emergent facility have been authorized. Also, on Monday, FDA issued an EUA for ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test. It can be used to test both symptomatic and asymptomatic individuals without the need for repeat testing over several days, known as serial testing. Separately, last week, FDA also issued a warning letter to Strategia Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims.  (Authored by Randy Prebula)

• After a long debate, the Italian government issued Law Decree no. 127/2021 providing the obligation for all kind of Italian workers to show the Green Pass to enter any workplace, included third-party workplace. The Green Pass is a QR code generated by the Health Minister confirming alternatively: (i) the COVID-19 vaccination; (ii) a negative COVID-19 test result (both molecular and rapid antigen test included in the European List are valid); or (iii) recovery from COVID-19. To such extent, all employers must implement by 15 October 2021 appropriate organizational procedures ruling how they will verify compliance with Green Pass by the workers. In case of non-compliance, besides possible ordinary disciplinary measures, administrative sanctions are provided by the Decree. We analyzed this decree in greater depth online here. (Authored by Vittorio Moresco)

• In a new analysis online here, we look at current trends and developments at the intersection between insolvency and dispute resolution in the UK, including a rundown of some of the latest legislative changes, and issues to consider when litigating against parties in financial distress. The coronavirus pandemic had ushered in a much-awaited reform of UK insolvency legislation, in the form of the Corporate Insolvency and Governance Act 2020 (CIGA 2020). As its explanatory notes record, the policy objective behind CIGA 2020 is to provide businesses with necessary flexibility and breathing space in the light of the effects of the coronavirus pandemic to maximize their chances of survival.  (Authored by John Tillman)

Compiled by Aaron Armstrong