COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

In this week's Report: FDA authorizes AstraZeneca & Regeneron antibody shelf-life extensions, GAO sees need for “Public Health Situational Awareness Network,” FDA advisers recommend updating vaccines, and an analysis of how lifting the state of epidemic in Poland is affecting economic entities.

Wednesday, 29 June 2022

  • The state of epidemic for COVID-19 in Poland was lifted and replaced by the state of epidemic emergency. Special regulations of a substantive and procedural nature related to the epidemiological situation were introduced during the period of this epidemic state. An analysis of these provisions shows that a number of them only apply up until a particular time after the epidemic state has been revoked, whereas others apply until the complete revocation of the state of epidemic emergency. This distinction can be very important in terms of the proper application of the regulations and the fulfilment of tax obligations. Online here we have analyzed how lifting the state of epidemic in Poland is affecting economic entities. (Authored by Andrzej Debiec)

  • Yesterday, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. This followed FDA’s Monday authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together (REGEN-COV). FDA also held a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified; FDA advisers voted 19-2 in favor of updating coronavirus vaccines by Pfizer and Moderna to improve efficacy against the omicron strain, though they did not specify which substrain of omicron the vaccines should target. (Authored by Randy Prebula)

  • Last week, the U.S. Government Accountability Office (GAO) issued a report on “Pandemic Lessons Highlight Need for Public Health Situational Awareness Network.” Also last week, HHS published a report on “Office of Refugee Resettlement's Influx Care Facility and Emergency Intake Sites Did Not Adequately Safeguard Unaccompanied Children From COVID-19.” Meanwhile, the U.S. Centers for Disease Control and Prevention (CDC) announced it is rescinding the “Requirement for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery from COVID-19 for All Airline or Other Aircraft Passengers Arriving Into the United States From Any Foreign Country.” (Authored by Cybil Roehrenbeck)

 

Wednesday, 22 June 2022

  • Last week, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. For the Moderna COVID-19 Vaccine, FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. In total, as of Friday, 438 tests and sample collection devices are authorized by the FDA under EUAs. (Authored by Randy Prebula)

  • Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping stem cell clinics that put patients at risk. Recent court rulings in favor of the agency, including the Eleventh Circuit affirming the lower court’s decision in US Stem Cell Clinic that the unproven stem cell therapy is subject to FDA regulation, likely will lead to increased enforcement action against unapproved stem cell therapies. While cell-based regenerative medicine has the potential for significant public health benefits, FDA has made clear that the agency “cannot allow unproven products that exploit the hope of patients and their loved ones.” This summer and beyond, we expect stepped up enforcement actions by FDA against parties marketing unapproved stem cell products, especially as FDA returns to full operational capacity and barriers to inspections arising from the COVID-19 pandemic wane. Read more online here. (Authored by Lowell Zeta)

  • During the last decade, the shape and source of capital flows and investment have fundamentally shifted. Private capital continues to flow into all asset classes including real estate, infrastructure, private credit, and private equity. The COVID-19 pandemic has most recently brought both challenges and opportunities for private capital investors. To minimize the risk and optimize the return on investments, efficient structuring of carried interest schemes has become more important than ever. With high amounts of money at stake and a coming global economic recovery, fund managers will want to receive their carried interest and co-investment returns in the most tax effective way - whether structured as classic carried-interest, ratcheted carry, hybrid carry, diverted carry, multi-waterfall carry, super carry or as a single performance-based fee. Take a look at our carried interest for fund managers toolkit, which highlights the main tax structuring products available for carried interest payments to fund managers in the major fund jurisdictions - France, Germany, Luxembourg, the Netherlands, Spain, the UK, and the U.S. (Authored by Cristina Arumi)

 

Wednesday, 15 June 2022

  • On Friday, the U.S. Food and Drug Administration (FDA)  issued an emergency use authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system, which is the first COVID-19 test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages. Yesterday, FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss requests to amend the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age, and to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age; an FDA report showed the Pfizer vaccine as safe and effective for children younger than five, and FDA also said the Moderna shot is safe and effective for infants and young children. Separately, an FDA Independent Vaccine Advisory Committee voted to recommend that regulators authorize the Novavax's Covid-19 vaccine for emergency use in adults. Also last week, Moderna reported that its Omicron-specific mRNA booster shot produced a robust immune response against the variant. Meanwhile, Sanofi and GSK said their experimental booster vaccine delivers a more powerful immune response against coronavirus variants than their competitors’. (Authored by Randy Prebula)

  • Telehealth providers should prepare to comply with the HIPAA health privacy law once the federal public health emergency (PHE) ends, HHS said in a guidance Monday. The Senate HELP Committee will hold a hearing tomorrow on “An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning.” A 9 June letter to Senate Minority Leader Chuck Schumer (D-NY) called for a permanent extension of COVID-19 era Affordable Care Act Tax Credit (APTC) that made health insurance more affordable for millions of Americans during the pandemic. The U.S. threw out 82.1 million COVID vaccine doses from Dec. 2020 through mid-May; vaccine providers say declining demand, large minimum orders, and multidose vials make it hard to avoid waste while still offering shots to anyone who wants them. Last week, the Biden Administration released details of its COVID-19 vaccination plan for children under 5, the last age group in the country without access to the vaccine. The World Trade Organization (WTO) is holding a long-delayed ministerial conference to craft a response to the pandemic, but the issue generating the most debate is a highly controversial proposal to temporarily waive IP rights for vaccines. (Authored by Cybil Roehrenbeck)

 

Wednesday, 8 June 2022

  • Germany is one of the most important and developed health care markets in the world. Legal developments are complex and often connected, whether in the areas of advanced therapies, digital health solutions, supply chain management, licensing transactions/collaborations/M&A, or COVID-19. Hogan Lovells Partners Andreas von Falck, Martin Pflüger, Jörg Schickert, and Matthias Schweiger share their insights on the trends and developments for the German market in the latest Chambers Life Sciences 2022 guide.

  • The U.S. Food and Drug Administration (FDA) held a virtual meeting yesterday of the Vaccines and Related Biological Products Advisory Committee to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. FDA concluded that the Novavax vaccine was about 90% effective at preventing mild, moderate, and severe COVID-19 when tested in a study involving about 30,000 volunteers ages 18 and older. Yesterday, FDA published a notice of withdrawal of its Q&A guidance on “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices,” effective 7 July. Last week, Pfizer/BioNTech asked FDA to authorize three doses of their vaccine for children under 5. On Friday, FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19 online here.  Also last week, FDA said in a blog post that it now has the staff it needs to review pre-submissions for devices that aren’t related to the pandemic. (Authored by Randy Prebula)

  • Last week, U.S. Reps. Jason Smith (R-MO), Jim Jordan (R-OH), Blaine Luetkemeyer (R-MO), and Kevin Brady (R-TX) wrote a letter to U.S. Attorney General Merrick Garland asking to be updated about reports of COVID-19 related fraud and what actions Associate Deputy Attorney General Kevin Chambers, who is to serve as Director for COVID-19 Fraud Enforcement, is planning to take. On 31 May, the Government Accountability Office (GAO) issued a report regarding private health insurance, headlined: “Limited Data Hinders Understanding of Short-Term Plans' Role and Value During the COVID-19 Pandemic.” The Centers for Medicare & Medicaid Services (CMS) released an updated public use file (PUF) that presents a preliminary, high-level overview of Medicare utilization and spending information from Medicare FFS claims related to the administration of COVID-19 vaccines. (Authored by Cybil Roehrenbeck)

 

Wednesday, 25 May 2022

  • NIH has awarded approximately $577 million to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern; the AViDD centers will conduct innovative, multidisciplinary research to develop candidate COVID-19 antivirals, especially those that can be taken in an outpatient setting, as well as antivirals targeting specific viral families with a high potential to cause a pandemic in the future. An NIH-supported research team has identified characteristics of people with long COVID and those likely to have it. On 19 May, CDC recommended that children ages 5 to 11 should receive Pfizer COVID-19 booster shots; the vote tally was 11-1 with one abstention. The Biden Administration announced that Americans can order additional free at-home, rapid tests at COVIDTests.gov. The HHS Office of the Assistant Secretary for Preparedness & Response released an update on COVID-19 Therapeutics Distribution. (Authored by Cybil Roehrenbeck)

  • FDA’s vaccine advisers are expected to meet June 15 to discuss Pfizer’s and Moderna’s COVID-19 vaccines for kids ages 6 months to 4 years and 6 months to 5 years, respectively, FDA announced Monday. Last week, FDA published the refreshed Know Your Treatment Options for COVID-19 Consumer Update with the latest information on COVID therapies. The FDA has approved two drug treatments for COVID-19 and has authorized others for emergency use during this public health emergency. (Authored by Randy Prebula)

 

Wednesday, 18 May 2022

  • On Monday, the U.S. Food and Drug Administration (FDA) authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19. This product is the first direct-to-consumer (DTC, non-prescription) multi-analyte COVID-19 test authorized by FDA, and the test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, commonly known as the flu, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2. Yesterday, FDA had amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the vaccine. (Authored by Randy Prebula)

  • The U.S. Department of Health & Human Services (HHS) will extend the COVID-19 public health emergency (PHE) past July, a person familiar with the matter told Bloomberg. The U.S. House Oversight and Reform Subcommittee on the Coronavirus Crisis held a hearing on “Underpaid, Overworked, and Underappreciated: How the Pandemic Economy Disproportionately Harmed Low-Wage Women Workers.” At the second Global COVID-19 Summit last week, U.S. President Biden announced that NIH has licensed 11 COVID-19 research tools and early-stage vaccine and diagnostic candidates to the Medicines Patent Pool (MPP) through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). The licenses will allow manufacturers from all around the world to work with MPP and C-TAP to use these technologies for the potential development of COVID-19 vaccines, treatments, and diagnostics to benefit people living in low- and middle-income countries. The White House released a fact sheet about the 2nd Global COVID-⁠19 Summit; additional new commitments including more funding for pandemic preparedness at the World Bank. (Authored by Cybil Roehrenbeck)

  • The COVID-19 pandemic remains a dominant theme in our forward looking view for companies in the life sciences and health care industry, as the past year has continued to create challenges and a seemingly endless stream of lockdowns and viral surges. While uncertainties abound, we remain hopeful that the innovations necessitated by our collective pivot to pandemic life will become a part of our new normal. Our annual Life Sciences and Health Care Horizons publication identifies a number of evolving trends such as precision medicine, AI, virtual health solutions, advanced analytics, and related cybersecurity measures that are shaping the future of the industry. With perspectives from around the world in Asia-Pacific, Europe, Latin America, and the U.S., its provides creative strategies for your most promising opportunities and integrated solutions that protect and support your business when issues arise. (Authored by Lynn Mehler)

  • Germany is one of the most important and developed healthcare markets in the world. Legal developments are complex and often connected, whether in the areas of advanced therapies, digital health solutions, supply chain management, licensing transactions/collaborations/M&A, or COVID-19, to name a few. Read the full chapter on trends and developments in the German market in the Chambers Life Sciences 2022 Guide online here. (Authored by Andreas von Falck)

 

Wednesday, 11 May 2022

  • FDA News: Yesterday, the U.S. Food and Drug Administration (FDA) approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). FDA also said last week it is limiting the use of certain COVID-19 vaccines, citing findings of potential rare side effects. FDA published revised guidance on “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions” during the COVID-19 Public Health Emergency (PHE). CBER Director Peter Marks recently told lawmakers that FDA might accept less than 50% efficacy for COVID-19 vaccines for kids, especially if the vaccines mirror the efficacy for adult vaccines, as the agency faces pressure to authorize a vaccine for children under the age of 5. Sen. James Clyburn (D-SC) said FDA is willing to move up the tentatively held meeting dates of its independent vaccine advisory panel should agency reviewers complete their analyses of data on pediatric COVID-19 vaccines more quickly than expected. (Authored by Randy Prebula)

  • Other U.S. News: The Biden Administration’s concerns about a coming COVID-19 wave continue, as do funding requests for vaccine administration and other measures, and President Biden is planning his second global vaccine summit, which Press Secretary Jen Psaki said will highlight that "our job is not done." The CDC released updated mask guidance recommending that everyone aged 2 and older wear a mask or respirator in indoor areas of public transportation and transportation hubs. The Senate Appropriations Subcommittee on State, Foreign Operations, and Related Programs will hold a hearing today on the global food security and COVID-19 crises. FEMA will also hold a meeting today under the Pandemic Response Voluntary Agreement under Section 708 of the Defense Production Act to establish a national strategy for the coordination of national multimodal health care supply chains to respond to COVID-19. U.S. Senators wrote a letter to CMS Administrator Chiquita Brooks-LaSure supporting CMS’s efforts to empower pharmacists to serve as Medicare providers “to increase access to testing and get shots in arms.” Also last week, other Congressmen wrote to companies contracting with states to assist in determining who is eligible for Medicaid and Children’s Health Insurance Program (CHIP) coverage at the end of the COVID-19 PHE. (Authored by Cybil Roehrenbeck)

 

Wednesday, 4 May 2022

  • The U.S. Food and Drug Administration (FDA) announced plans to hold meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers, including meetings regarding vaccines manufactured by Novavax, Pfizer-BioNTech, Moderna, and one meeting on whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. On Thursday, Moderna became the first vaccine maker to ask the FDA to authorize a COVID-19 shot for kids under age 6; Pfizer is expected to also soon submit an emergency use application for its vaccine for young children. On Friday, FDA warned there are counterfeit versions of the Flowflex COVID-19 Test Kits and iHealth COVID-19 Antigen Rapid Test Kits, which are at-home over-the-counter (OTC) COVID-19 diagnostic tests. FDA also updated its At-Home COVID-19 Diagnostic Tests FAQ to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test. Also last week, FDA updated the Digital Health Policies and Public Health Solutions for COVID-19 web page to include the FDA’s current policies that may support public health innovation in COVID-19-related digital health technologies and the response to COVID-19. Meanwhile, Celltrion is recalling certain Point of Care (POC) DiaTrust COVID-19 Ag Rapid Tests because they may have been distributed to unauthorized users. (Authored by Randy Prebula)

  • Lawmakers questioned HHS Secretary Xavier Becerra about the apparent end of the COVID-19 pandemic, noting at a hearing last week that more than two years of addressing COVID-19 have added to public mistrust of health officials. Secretary Becerra was also asked to explain what Republicans consider an inconsistency in the Administration’s domestic pandemic policy and its treatment of migrants on the southwestern border. The panel’s Democratic chairwoman, addressing the FY-2023 HHS budget that Becerra was there to justify, expressed concern about the use of health research appropriations. Meanwhile, the White House and House Democrats' plan to link a $33 billion aid package for Ukraine to a COVID-19 supplemental funding bill is receiving bipartisan opposition. HRSA held a meeting today and tomorrow of the National Advisory Council on Nurse Education and Practice on the nursing workforce, nursing practice improvement, nursing education, and the response to the COVID-19 pandemic. U.S. Reps. Cynthia Axne (D-IA) and Richard Hudson (R-NC) introduced the “Telehealth Extension and Evaluation Act,” which aims to ensure key telehealth services offered during the COVID-19 pandemic will continue for two years after the end of the COVID-19 public health emergency. A new CDC study shows that most Americans have already had COVID-19. (Authored by Cybil Roehrenbeck)

  • On 9 September 2021, a panel of experts convened to discuss the use of immunoglobulin (Ig) therapies, detail the therapeutic benefits of Ig therapies for various disease states, offer practitioner insights on the impact of the COVID-19 global pandemic on patient treatment, and discuss how policies can play a role in optimal patient treatment with Ig therapies. Online here, we have summarized key takeaways emerged from the presentation and the subsequent roundtable conversation among clinicians. You can view the full report here. (Authored by Stuart Langbein)

  • Over the past decade, China’s life sciences and health care sector has experienced unprecedented growth. China presents real opportunities for life sciences and health care companies, but knowing the evolving laws, regulations, rules and relevant guidance, and being able to navigate them successfully, require deep insights and experience. Hogan Lovells’ APAC life sciences and health care lawyers will host a series of webinars throughout 2022 that will look at the trends and challenges that companies in the life sciences and health care industry may be facing when planning or conducting business in Greater China. Partly in response to feedback from our clients, the series will feature informative presentations, cutting-edge analysis and engaging discussions, covering topics including in-country and cross-border handling and transfer of human generic resources and other personal data, cross-border license transactions, pandemic related issues, and key intellectual property issues such as patent linkage and patent term extension. We are delighted to invite you to the inaugural session of our APAC life sciences and health care webinar series on Tuesday, 17 May 2022, for which you can register online here. (Authored by Dr. Frederick Ch'en)

  • The COVID-19 crisis called for governmental responses of unprecedented scale, scope, and speed. Flexible regulatory approaches emerged by necessity to allow FDA and USDA to respond to the public’s need for access to food, personal protective equipment, and other critical items. Designated “critical infrastructure sectors,” key industries required decisive shifts in how these agencies traditionally go about the business of regulation to protect public welfare during the evolving pandemic. Viewing agency actions through the lens of the food industry, our latest article in the Food and Drug Law Journal analyzes the key regulatory flexibility strategies used by FDA and USDA (in conjunction with CDC and other agencies), identifies key learnings from how those strategies worked in the initial phase of the COVID-19 crisis, and explores ways for regulatory agencies to build on those processes, both for future crisis response and day-to-day regulatory activities. (Authored by Brian D. Eyink and Elizabeth B. Fawell)

 

Wednesday, 27 April 2022

  • On Monday, the U.S. Food and Drug Administration (FDA) expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, making Veklury the first approved COVID-19 treatment for children less than 12 years of age. Biden Administration chief medical adviser Anthony Fauci said FDA may wait until June to consider authorizing COVID-19 vaccines for kids under 5, though officials want to make Pfizer’s and Moderna’s products available simultaneously to minimize confusion. (Authored by Randy Prebula)

  • In an article published last week, BioSpace explained how life sciences firms will need to revert to normal operations post-pandemic, including adherence to the antitrust regulations that were waived during the public health emergency (PHE). The actual end of the pandemic and its legal end are different, Philip Katz, partner in the pharmaceuticals & biotechnology regulatory practice at Hogan Lovells, told BioSpace. Katz forecast that FDA will not be in a hurry to declare an end to the PHE justifying emergency use authorizations (EUAs); but nevertheless, the end of the PHE will affect FDA’s ability to be lenient regarding the extension of product expiration dates, deviations in good manufacturing practices, and allowing prescription products to be dispensed without individualized prescriptions. Katz explained how in the future, “There’s going to be a difficult public discussion about when we start treating COVID-19 like the flu.” You can read more of Katz’s insights online here.

  • Sponsors of clinical trials in the U.S. have a regulatory responsibility to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every clinical trial site participating in the study. The COVID-19 pandemic made in-person monitoring impossible and pushed remote monitoring to the forefront. In March 2021, FDA published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” which suggests the use of “central and remote monitoring programs to maintain oversight of clinical trials” if on-site monitoring is not possible. Remote monitoring has proven to be a useful and cost-effective tool during the COVID-19 pandemic and it will likely continue to be used by Sponsors and CROs for monitoring clinical studies. However, it is not always easy to obtain remote access to a clinical site’s electronic health records. Hospitals are subject to various state and federal privacy laws, which impose privacy and security obligations on health information. We have analyzed the key issues related to remote monitoring terms in Clinical Trial Agreements online here. (Authored by Elizabeth McGuire)

  • Following a two-week recess, Congressional lawmakers returned to Washington, DC to consider FY-2023 appropriations and additional COVID-19 funding. The Democratic majority may attempt to tie the COVID-19 relief bill to the legislation that would provide additional support for Ukraine, raising its prospects for additional consideration. On Friday, the House Oversight & Reform Coronavirus Crisis Subcommittee will hold a hearing on "Ensuring Scientific Integrity at Our Nation's Public Health Agencies." Today, FEMA will hold a meeting under the Pandemic Response Voluntary Agreement Under Section 708 of the Defense Production Act to establish a national strategy for the coordination of national multimodal health care supply chains to respond to COVID-19. The Biden Administration announced a series of initiatives aimed at increasing the use of antiviral pills to treat COVID-19. Sens. Sheldon Whitehouse (D-RI) and Ed Markey (D-MA) are pressing the NIH to respond about the slow pace of research into “long COVID,” or “Post-Acute Sequelae of SARS-CoV-2 infection.” (Authored by Cybil Roehrenbeck)

  • In the latest edition of our securities, shareholder, and M&A litigation outlook for 2022, we analyze key developments from 2021 and discuss how the most important cases from Delaware may impact companies now and in the year to come. Among the themes observed in Delaware courts, which we expect to continue in 2022, is courts addressing the continued impact of COVID-19, issuing two significant decisions on COVID-19 and M&A transactions. (Authored by Ryan M. Philp)

 

Wednesday, 20 April 2022

  • The U.S. Secretary of Health and Human Services (HHS) has renewed its determination that a public health emergency exists in light of the continued consequences of the COVID-19 pandemic. The determination has been in place since 31 January 2020, and was set to expire on 16 April 2022. Temporary flexibilities and enforcement discretion put in place by the Food and Drug Administration (FDA) in response to this determination are expected to remain in effect for the duration of the public health emergency. Read more about this online here. (Authored by Elizabeth Fawell)

  • FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test, which is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. In March, FDA had amended the Moderna COVID-19 vaccine EUA, and now the Centers for Medicare and Medicaid Services (CMS) has issued new codes for the Modern vaccine booster and administration, available online here. (Authored by Randy Prebula)

  • The U.S. House recently passed a $10 billion COVID-19 relief bill, but the Senate adjourned without passing the measure. Senate Republicans are objecting to the supplemental that would provide more therapeutics, vaccines, and testing supplies and by trying to push through an amendment that would prevent the Biden administration from ending Title 42, which is a federal health order limiting border crossings during public health emergencies. Outgoing White House COVID-19 Response Coordinator Jeff Zients released a statement calling on Congress to pass funds when it returns next week, saying, "The virus is not waiting on Congress to negotiate." (Authored by Cybil Roehrenbeck)

 

Wednesday, 13 April 2022

  • The COVID-19 pandemic revealed many potential supply chain shortages in the United States, and in response, the U.S. Department of Defense (DOD) has issued its long-awaited report in response to last year’s Executive Order 14017, Securing America’s Supply Chains, which called for a comprehensive review of supply chains in critical sectors, including the defense industrial base (DIB). The report, titled “Securing Defense-Critical Supply Chains,” assesses supply chains in the DIB and sets out DOD’s plan to align its priorities and capabilities to strengthen the industrial base and to establish a network of domestic and allied supply chains to meet national security needs. We have analyzed the report online here. (Authored by Michael Mason)

  • On 20 April, the U.S. Food and Drug Administration (FDA) will host the next virtual Town Hall for SARS-CoV-2 test developers. On 7 April, FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. On the same day, FDA authorized two over-the-counter (OTC) at-home COVID-19 antigen tests; one to Osang for their OHC COVID-19 Antigen Self-Test, and one to Xiamen Boson Biotech for their Rapid SARS-CoV-2 Antigen Test Card. Also last week, FDA issued a warning letter to Sensory Cloud, Inc for selling unapproved products with unproven COVID-19 claims. On 11 April, the U.S. Centers for Medicare and Medicaid Services (CMS) issued its fiscal year (FY) 2023 Skilled Nursing Facilities Prospective Payment System (SNF PPS) proposed rule; announcing the proposed rule, CMS Administrator Chiquita Brooks-LaSure said, “The COVID-19 pandemic has highlighted serious problems at some of the nation’s nursing homes that have persisted for too long. And we have seen the tragic impact that inadequate staff resources can have on residents and staff.” (Authored by Randy Prebula)

 

Wednesday, 6 April 2022

  • U.S. news: Yesterday, U.S. President Joe Biden tasked the U.S. health department with developing a national action plan to tackle the looming health crisis of long COVID; it will be called the National Research Action Plan and released within 120 days. Biden’s FY-2023 budget request includes $81.7 billion for pandemic efforts over five years. The Administration is also preparing for additional booster shots after greenlighting a second mRNA booster dose for everyone over the age of 50. The new COVID-19 subvariant isn’t yet causing concern among public health officials, but Omicron subvariant BA.2 is at least 30% more transmissible than the original strain and is already the dominant variant in the U.S. The Biden Administration and hospitals are gearing up for another potential case surge. The Administration announced on 4 April that Medicare will cover over-the-counter COVID-19 tests at no upfront cost to beneficiaries through a national demonstration program. In a study published 21 March in Lancet, researchers found that people who had COVID-19 were about 40% more likely to develop diabetes within a year after recovering, compared to participants in a control group. (Authored by Cybil Roehrenbeck)

  • FDA news: Today, the U.S. Food and Drug Administration (FDA) is holding meeting today of the Vaccines and Related Biological Products Advisory Committee to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants. On Thursday, FDA finalized its vaccine EUA guidance, adding information about its evaluation of clinical data to support effectiveness of a modified vaccine, focusing on immunogenicity analyses. Yesterday, FDA announced sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. FDA also posted new Q&A for Spikevax (COVID-19 Vaccine mRNA). A large study published last week in the New England Journal of Medicine found that the anti-parasitic drug ivermectin was ineffective in reducing the risk of hospitalization for COVID-19. (Authored by Randy Prebula)

  • Italy’s recent Law Decree No. 24/2022 (available, here, in Italian), entered into force on 25 March 2022, updating employment related anti-COVID-19 measures. The Decree provides for an extension until 30 June 2022 of the so called “simplified agile work” policies in Italy. We have analyzed the Decree online here. (Authored by Vittorio Moresco)

  • The UK published new guidance on reducing the spread of respiratory infections, including COVID-19, in the workplace. This replaces the earlier working safely during coronavirus guidance and reflects the fact that now that widespread COVID-19 testing has ended, it will be more difficult to know if a worker has COVID-19, or another respiratory illness. We have analyzed that guidance online here. (Authorized by Ed Bowyer)

 

Wednesday, 30 March 2022

  • FDA news: The U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. FDA issued warning letters to Iodine Products Inc. and Applied Biological Laboratories Inc. for selling unapproved products with unproven COVID-19 claims. FDA also issued warning letters to seven companies for selling CBD products using research studies to claim or imply misleadingly that their CBD products will cure, mitigate, treat or prevent COVID-19: Cureganics; Heaven’s Organics LLC; Functional Remedies, LLC D/B/A Synchronicity Hemp Oil; Greenway Herbal Products LLC; CBD Social; UPSY LLC; and Nature’s Highway. Also this past week, FDA added to its Q&A web page information about leveraging validation data from a study on the adequacy of pediatric self-swabbing to collect a sample for COVID-19 diagnostic testing. (Authored by Randy Prebula)

  • COVID-19 budget update: U.S. President Biden unveiled his $5.8 trillion FY-23 budget request on Monday, including $81.7 billion for pandemic-related activities over five years. Congress is still wrestling with how to authorize additional funding for COVID-19 after failing to include it in the FY-22 consolidated appropriations bill, as the government has run out of funds for some of its programs, including the uninsured fund. On 6 April, the Health Resources and Services Administration (HRSA) will stop reimbursing providers who vaccinate uninsured people. COVID-19 Response Coordinator Jeffrey Zients said that funding for a possible fourth dose of the vaccine is also at risk as the U.S. Centers for Disease Control (CDC) warns about the Omicron sub-variant. U.S. Sens. Tim Kaine (D-VA), Chuck Schumer (D-NY) Mitt Romney (R-UT), and Sen. Roy Blunt (R-MO) are holding bipartisan discussions on new ways to offset $15 billion or more in supplemental COVID-19 aid. The Administration is still pushing for $22.5 billion it says is needed soon for the government to continue procuring therapeutics, testing supplies, and vaccines for Americans to get a fourth booster shot later this year. Meanwhile, Reps. Ron Kind (D-WI), Nanette Barragán (D-CA), Buddy Carter (R-GA) introduced the Equitable Community Access to Pharmacist Services Act, which would provide coverage for pharmacist services under Medicare Part B, including vaccinations for COVID-19 and influenza, testing for COVID-19, Influenza, Strep Throat, and Respiratory Syncytial Virus and treatment for COVID-19, Influenza, and Strep Throat. Last week, HRSA announced it will distribute $413 million in Provider Relief Fund (PRF) Phase 4 payments to more than 3,600 health care providers impacted by COVID-19. (Authored by Cybil Roehrenbeck)

  • Other U.S. news: Republican lawmakers are pressuring the Biden Administration to lift the public health emergency (PHE) declaration this year as COVID-19 case counts decline. The PHE is set to expire on 16 April, but the U.S. Health and Human Services Department (HHS) said it would give at least 60 days’ notice before ending it. On 22 March, the Occupational Safety and Health Administration (OSHA) announced a partial reopening of the comment period for the COVID-19 emergency temporary standard for the health care industry, and OSHA said it intends to hold a public hearing on COVID-19 prevention policy for health care providers on 27 April before finalizing the rule. On Thursday, the U.S. House Committee on Space, Science, and Technology will hold a hearing on “The New Normal: Preparing for and Adapting to the Next Phase of COVID-19.” The Africa, Global Health, Global Human Rights Subcommittee of House Foreign Affairs Committee will hold a hearing on "Present Challenges and Progress on COVID-19 in Africa” on Thursday as well. The CDC reported on the use of at-home COVID 19 tests, finding a rapid increase in U.S. at-home test use between the SARS-CoV-2 Delta- and Omicron-predominant periods; at-home test use was lower among persons who self-identified as Black, were aged ≥75 years, had lower incomes, and had a high school level education or less. (Authored by Cybil Roehrenbeck)

  • Effective 24 March 2022, the Virginia occupational safety and health standard on COVID-19 has been revoked. The standard established protocols that Virginia employers were required to follow to control, prevent, and mitigate the spread of COVID-19 in the workplace and was the first such occupational safety and health standard in the U.S.  In place of the standard, the Virginia Department of Labor and Industries (DOLI) is now directing employers to the DOLI’s new nonbinding guidance entitled “Guidance for Employers to Mitigate the Risk of COVID-19 to Workers.” Virginia employers should review the new guidance (including any updates resulting from public comment), as well as safety guidance issued by the Virginia Department of Health. Read more online here. (Authored by George Ingham)

 

Wednesday, 23 March 2022

  • FDA news: The U.S. Food and Drug Administration (FDA) issued an FAQ on at-home COVID-19 diagnostic tests on Friday. FDA announced Monday it will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 6 April to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Moderna is seeking approval for a fourth vaccination shot, pending a grant for emergency authorization use from the FDA, the company announced Thursday. On Monday, FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes, which are in shortage because of an increase in demand during the COVID-19 PHE. (Authored by Randy Prebula)

  • Other U.S. news: The Biden Administration continues to push for additional COVID-19 funding, as the budget for uninsured persons to receive COVID-19 treatments will expire unless Congress passes supplemental legislation. President Biden will deliver his FY-23 budget request on 28 March, which will likely give an indication of the Administration's pandemic policy priorities. Given the temporary extension of certain public health emergency (PHE) items in the omnibus funding bill (e.g., certain telehealth flexibilities), it is anticipated that other COVID-related regulatory items may be addressed in forthcoming CMS annual rulemaking. Last week, GAO released a report on COVID-19 emergency relief funds that warned “significant improvements are needed to ensure transparency and accountability.” (Authored by Cybil Roehrenbeck)

 

Wednesday, 16 March 2022

  • FDA news: The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) posted new items on FDA.gov this week, including revised, reissued, and updated Emergency Use Authorizations (EUAs). On Monday, FDA issued a Class I recall for COVID-19 antigen and IgG/IgM antibody tests by LuSys Laboratories because they are not FDA cleared, authorized, or approved. On the same day, FDA also announced it revoked the EUAs issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions Medical Corporation for the Omni COVID-19 Assay by RT-PCR. (Authored by Randy Prebula)

  • Other U.S. news: The U.S. Congress passed the Consolidated Appropriations Act of 2022 (H.R. 2471) last week, which extends a number of COVID-19 Medicare telehealth flexibilities for 151 days after the end of the Public Health Emergency (PHE), and defers several CMS regulatory actions. It did not include COVID-19 supplemental appropriations, but funding was introduced as a separate stand-alone bill; the House plans to vote on the supplemental measure this week. Without the funds, the Biden Administration says its stockpile of testing supplies and antiviral drugs will be depleted. Yesterday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a markup of the "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics” (PREVENT Pandemics) ACT. Sens. Thomas Carper (D-DE) and Tim Scott (R-SC) also introduced a bill called the “Hospital Inpatient Services Modernization Act,” which would extend CMS waiver flexibilities brought on by the pandemic to bring hospital-level care directly to patients in their homes. CMS published guidance on clinical laboratory improvement amendments (CLIA) for temporary testing sites under the multiple site exception, which clarifies the PHE-related enforcement discretion as it relates to remote testing. The National Institute of Allergy and Infectious Diseases (NIAID) is conducting a clinical trial designed to help understand rare but potentially serious systemic allergic reactions to COVID-19 mRNA vaccines. CDC invited comments on a proposed information collection project titled “Assessing the Availability of COVID–19 Testing at U.S. Airports.” CDC also issued a report last week on effectiveness of 2-dose BNT162b2 (Pfizer-BioNTech) mRNA vaccine in preventing SARS-CoV-2 infection among children and adolescents. (Authored by Cybil Roehrenbeck)

 

Wednesday, 9 March 2022

  • U.S. President Biden is pushing for $22.5 billion more in supplemental COVID-19 funding, as the White House says the U.S. will run out of critical medical supplies in the coming months unless additional funds are provided; however, many Republicans oppose additional funding given that there is COVID-19 relief money that has not been spent. The White House also published a “National COVID-19 Preparedness Plan” that lays out the roadmap to combat COVID-19 in the future, and public health experts anticipate the Biden Administration will move cautiously in setting new pandemic policies due to the fast-spreading BA.2 Omicron subvariant. Yesterday, the U.S. House Judiciary Subcommittee on Crime, Terrorism and Homeland Security held a hearing on "Reimagining Public Safety in the COVID-19 Era." Last week, the U.S. Centers for Disease Control and Prevention (CDC) released updated guidance for antigen testing for SARS-CoV-2 for health care providers testing individuals in the community. It also released additional guidance and resources to help states maintain Medicaid and Children’s Health Insurance Program (CHIP) coverage for individuals after the COVID-19 public health emergency ends, or transition them to other affordable coverage options. Last, CMS issued a memorandum on 3 March to state health officials regarding continuity of coverage and distributing eligibility and enrollment workload upon conclusion of COVID-19 health emergency. (Authored by Cybil Roehrenbeck)

  • The American Bar Association’s annual white collar crime conference is often a favorite place for the U.S. Department of Justice to announce new policies and programs, and this year’s meeting in San Francisco was no exception. On 3 March, Attorney General Merrick Garland announced a DOJ hiring spree intended to bolster enforcement of white collar crime. His remarks also emphasized that holding individuals accountable, particularly those engaged in pandemic-related fraud, is a top priority for DOJ. At the same conference, the head of DOJ’s Criminal Division, Assistant Attorney General Kenneth Polite, discussed several programs designed to benefit victims of white collar crimes. Read more online here. (Authored by Peter Spivack)

  • On 17 March, Hogan Lovells Life Sciences & Health Care Senior Associate Madeline Gitomer will be featured in a panel discussion during the “Data Privacy & Public Health: The Impact of Covid-19 & Where We Go From Herewebinar hosted by the Executives for Health Innovation. This panel is the second in a series of online events focused on modernizing the public health system. Read more about our upcoming privacy & cybersecurity events online here.

 

Wednesday, 2 March 2022

  • The UK government’s Living with COVID plan removes the legal requirement in England for people who have COVID to self-isolate. However, government advice remains that those testing positive should stay at home and avoid contact with other people. This means that employers’ approaches to managing COVID risk in the workplace are unlikely to change significantly, at least in the short term. (Authored by Ed Bowyer)

  • FDA News: Yesterday, the U.S. Food and Drug Administration (FDA) issued three safety communication warnings over the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging, the SD Biosensor STANDARD Q COVID-19 Ag Home Test, and the ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Last week, FDA had revised the emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. FDA also updated its FAQ web page on antibody tests for SARS-CoV-2, as well as its antibody testing information page. Last week, CDRH also added meeting materials to its Virtual Town Hall Series web page.  (Authored by Randy Prebula)

  • U.S. News: President Biden discussed updated COVID-19 guidelines and getting the U.S. workforce back to work during last night’s State Of The Union address. Biden has extended the national emergency declaration for the COVID-19 pandemic, and the administration said it does not plan to terminate the separate “public health emergency” (PHE) designation used for Medicaid and entitlement program waivers on 15 April; instead, it will give health care groups at least 60-days’ notice when it plans to do so. The National Institute for Health Care Management Foundation held a virtual discussion yesterday on "Addressing Rural Health Needs: COVID-19, Equity and Access to Care." Last week, the Centers for Disease Control and Prevention (CDC) published a report on “Hospitalizations of Children and Adolescents with Laboratory-Confirmed COVID-19,” as well as a report on “Pediatric Emergency Department Visits Before and During the COVID-19 Pandemic.”  On 25 Feb., CDC relaxed its mask guidance for communities where hospitals are not under high strain. Also last week, Sanofi and GlaxoSmithKline said they intend to seek regulatory authorization for their COVID-19 vaccine in the U.S. and Europe amid the release of data they say is comparable to those from other authorized vaccines.  (Authored by Cybil Roehrenbeck)

 

Compiled by Aaron Armstrong

 

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