Tuesday, 30 March 2021

• The U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021. This Federal Register Notice announces fees established under the Federal Food, Drug, and Cosmetic Act (FDCA) with respect to OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2021. It includes information regarding facility fee calculations, OMOR fees, fee due dates, and fee payment options and procedures. The Notice includes an exemption for facility fees for firms that first registered with FDA on or after the 27 January 2020 declaration of the COVID-19 public health emergency solely to manufacture OTC hand sanitizer products. As a result of this exemption, firms still subject to facility fees will have to pay 45% more than FDA’s previous assessment in December 2020. OTC monograph drug facility fees for FY 2021 are due on May 10, 2021. Read more online here. (Authored by Heidi Gertner and David Horowitz)

• FDA also reorganized its In Vitro Diagnostics EUAs web page on Friday to make finding specific emergency use authorizations for COVID-19-related tests easier. The agency has made separate informational pages for:

  • Molecular Diagnostic Tests for SARS-CoV-2

  • Antigen Diagnostic Tests for SARS-CoV-2

  • Serology and Other Adaptive Immune Response Tests for SARS-CoV-2

  • IVDs for Management of COVID-19 Patients

• Last week FDA also updated its EUA template for developers making home-use coronavirus serology tests that use fingersticks to collect blood samples. The template, “Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot,” was updated “to add clarity throughout and provide updated recommendations for pre-collection stability,” the FDA said. This modified fingerstick EUA template comes a week after the FDA updated a general template for serology test developers and added a new one for serology tests that detect or correlate to neutralizing antibodies. (Authored by Randy Prebula)

• The roll-out of vaccinations against COVID-19 is gathering pace in the UK, and on the current timetable, all adults will have been offered a first vaccine by the end of July. This note answers UK employers’ FAQ regarding how to balance their health and safety obligations to staff with employees’ employment and data privacy rights. The discussion of possible employment law consequences assumes that an employer will only consider taking action against an employee if they have been offered but refused a vaccination. Younger employees without underlying health conditions may not be offered a vaccination before the end of July and taking action against employees before that point could result in age discrimination. (Authored by Stefan Martin)

• As employers anticipate returning to work in light of increased availability of vaccines, some have considered requiring employees to get a COVID-19 vaccination to return to the workplace. On 4 March 2021, California’s Department of Fair Employment and Housing (DFEH) updated its DFEH Employment Information on COVID-19 to address whether employers may mandate vaccines under the California Fair Employment and Housing Act (FEHA). The FEHA prohibits discrimination against employees based on protected characteristics, including disability and religious beliefs. Read more online here. (Authored by Tao Leung)

• In the 21^st episode of the A Perspective Podcast, Andrew Skipper talks with Charlie Robertson, Global Chief Economist and Head of Macro Strategy at Renaissance Capital. Focused on emerging, Frontier, and Africa markets, Charlie is often rated number 1 for Emerging Europe or Frontier/Africa commentary. Join them as they discuss a wide range of captivating topics including; why the 21st century is going to be better for Africa, what the continent needs to address to achieve industrialization, and the notion of supply chains and added value in Africa post COVID-19 and AfCFTA. Charlie also shares his views on which country has it right on the continent, vaccine diplomacy, why Education underpins all progress on the continent, and rounds off this illuminating conversation by giving us a reason to be cheerful.

Thursday, 25 March 2021

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The Senate voted 52-48 Wednesday to confirm Rachel Levine as Assistant Secretary of Health; and on Tuesday, the chamber passed Vivek Murthy for Surgeon General in a 57-43 vote. In response to AstraZeneca's Monday report of a 79 percent efficacy rate for preventing symptomatic COVID-19 cases, the National Institute of Allergy and Infectious Diseases (NIAID) released a statement saying the Data and Safety Monitoring Board “expressed concern” that AstraZeneca may have included “outdated information” from its U.S. trial, urging the company to work with the DSMB to review the efficacy data. Contract manufacturer Catalent, which is helping to produce Johnson & Johnson's coronavirus vaccine, was cleared Tuesday by the Food and Drug Administration (FDA), and has now started delivering millions of doses. The Biden Administration announced Tuesday that it will extend the special pandemic enrollment period for ObamaCare (ACA) plans until 15 August. Read about these developments online here: 23 Mar. and 24 Mar. (Authored by Ivan Zapien)

• On 19 March 2021, the U.S. Department of Health and Human Services postponed for one year the effective date of the Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET),” which would have required agency regulations, including those issued by FDA to be reviewed every ten years or otherwise expire. The Final Rule was finalized in the last days of the outgoing administration and was due to take effect on 22 March 2021. On 9 March 2021, a lawsuit was filed seeking to overturn the Final Rule on various grounds, including claims that it was not legally authorized, arbitrary, and capricious, and in violation of the Administrative Procedures Act and HHS’s Tribal Consultation Policy. HHS postposed the effective date under 5 U.S.C. 705, which allows an agency “to postpone the effective date of action taken by it, pending judicial review,” when “the agency finds that justice so requires.” Read more online here. (Authored by Joseph Levitt)

Tuesday, 23 March 2021

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The Biden Administration is considering a $3 trillion infrastructure plan that may split the economic recovery proposal into two bills. The proposal comes as the economy struggles through the coronavirus pandemic-caused recession. Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky on Monday urged states to maintain and individuals to adhere to anti-coronavirus restrictions as the U.S. has plateaued at a high level of about 50,000 daily new cases. CDC also released their new guidance for opening schools. The new social distancing guidelines say that students attending in-person instruction only need to stay three feet apart, rather than six, as long as universal masking is maintained. AstraZeneca announced on Monday that its vaccine was 79 percent effective in preventing symptomatic COVID-19 in phase three U.S. testing and 100 percent effective in preventing serious cases and hospitalizations. The Senate confirmed California Attorney General Xavier Becerra as Secretary of Health and Human Services by a 50-49 vote. Read about these developments online here: 18 Mar.;  19 Mar.; and 22 Mar. (Authored by Ivan Zapien)

• As employers are revising their return to work protocols in light of increased vaccination efforts and the prospect of increased on-site work, the U.S. government has been busy implementing additional COVID-19 safety measures for the workplace, including targeted on-site inspections of workplaces where workers may have been or are likely to be exposed to SARS-CoV-2. Among other actions, on 12 March 2021, the U.S. Occupational Safety and Health Administration (OSHA) issued a new National Emphasis Program (NEP), effective immediately, prioritizing inspections for “high-hazard industries or activities” where there is a hazard for contracting COVID-19 at the workplace. The NEP, published alongside an Updated Interim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19) (ERP) is a result of President Biden’s inauguration day Executive Order in which he directed OSHA to focus its enforcement on COVID-19 efforts. Biden’s executive order called for OSHA to consider implementing a potential nationwide Emergency Temporary Standard. We analyzed these new measures online here. (Authored by George W. Ingham)

• In this week’s "A Perspective" podcast, Andrew Skipper talks to the Executive Head of Non-Banking Financial Institutions and Global Markets at Standard Bank Group, Lindeka Dzedze. She is also the project lead for the Standard Bank Group and MiDA Advisors collaboration to connect U.S. investors to impactful capital deployment opportunities on the African continent. In addition, she is the chairperson of the African Women Impact Fund Executive Committee, an initiative of the UN Economic Commission for Africa (UNECA) and its partners. Join them as they discuss the importance of women’s initiatives and championing gender in the African context. They delve into the work of the African Women Impact Fund, its focus on female fund managers, and what exactly sets this particular impact fund apart from others. Lindeka also shares her thoughts on the importance of partnerships between the public and private sector and how COVID-19 has impacted the activities of such initiatives on the continent.

• Mediation has sometimes been described as a bit like marriage counseling. The mediator, like a counsellor, is there to listen to and facilitate discussions between the two parties in an attempt to identify common ground and areas of compromise. With global travel restrictions still in place, parties are increasingly exploring the possibility of holding virtual mediations. To a generation now fully accustomed to the dreaded "you're on mute" – we examine online here how best to handle a virtual mediation in the age of COVID-19. (Authored by Roberta Downey)

Thursday, 18 March 2021

• Yesterday, the U.S. Food and Drug Administration (FDA) granted BioFire Diagnostics LLC marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test. The grant of this De Novo request marks an important step in the FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed by FDA beyond the public health emergency. The BioFire Respiratory Panel 2.1: (a) is a multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab; (b) is for use only for people suspected of respiratory tract infections, including COVID-19; (c) should be used by health care providers in combination with a clinical examination and consideration of patient medical history; and (d) was granted marketing authorization using the De Novo premarket review pathway, meaning the FDA determined that special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for the device. (Authored by Randy Prebula)

Tuesday, 16 March 2021

• On 10 March, the U.S. House of Representatives passed, 220-211, the “American Rescue Plan Act of 2021” (H.R. 1319) as modified by the Senate - the sixth major coronavirus relief package that both chambers of Congress have passed since the U.S. effectively shut down in March 2020. Online here we analyze the American Rescue Plan Act, including its major provisions, timeline for implementation, and the few significant modifications in the Senate-passed bill that was sent back to the House for final passage. Among the Act's many notable implications for life sciences and health care companies: with regards to ACA Marketplaces subsidies, for 2021 and 2022, the bill removes the current cap that makes any family with income above 400% of the poverty level ineligible for any subsidies; the bill also creates a new incentive for the 12 states that have not expanded Medicaid to do so by temporarily increasing the base Federal Medical Assistance Percentage by five percentage points for two years; and the Act provides $7.6 billion for public health departments to hire 100,000 additional full-time employees into the public health workforce. (Authored by Anna Weinstein)

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. President Joe Biden is appointing Gene Sperling to oversee the implementation of the Administration’s $1.9 trillion coronavirus relief plan. National Institutes of Health (NIH) official Dr. Anthony Fauci said Sunday that the Centers for Disease Control and Prevention (CDC) is examining a new study indicating that social distancing measures could be just as effective at 3 feet as at 6 feet. Most people who have received their first dose of the coronavirus vaccine from Pfizer-BioNTech or Moderna are receiving the second dose on time, according to new research from the CDC. Novavax’s coronavirus vaccine is more than 96 percent effective against the original virus and prevents severe COVID-19 illness entirely, the pharmaceutical company announced Thursday. Read about these developments here: 11 Mar.; 12 Mar.; and 15 Mar. (Authored by Ivan Zapien)

Thursday, 11 March 2021

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The House on Wednesday passed a sweeping $1.9 trillion COVID-19 relief package in a 220-211 vote giving President Joe Biden a significant and historical legislative victory. The package includes many provisions beyond the well-known $1,400 direct payments, unemployment benefits extension, funding to reopen schools, and vaccine distribution funding measures.  President Biden announced that the Department of Health and Human Services (HHS) to secure 100 million more doses of Johnson & Johnson’s COVID-19 vaccine. HHS also announced it will be allocating $250 million in federal grants to local governments to address COVID-19 safety and vaccinations in minority communities. The Biden Administration revised its guidelines to allow indoor nursing home visits, regardless of whether guests or residents have been vaccinated in particular cases. Eli Lilly announced Wednesday that its antibody drug cut the risk of hospitalization and death from the illness by 87 percent. The number of drug company inspections conducted by the Food and Drug Administration (FDA) has dropped significantly due to the pandemic, resulting in a delay of new drug approvals. Read about these developments here: and 9 Mar. and 10 Mar. (Authored by Ivan Zapien)

• The New York State legislature recently passed bills (Bill S2588A; A3354B) that would provide all public and private employees in New York with up to four hours of paid leave to obtain the COVID-19 vaccine. The proposed law provides that the paid vaccination leave may not be charged against any other leave that the employee is entitled to, such as any paid sick leave or leave pursuant to any collectively bargained agreement. An employee will be entitled to up to four hours for each COVID-19 vaccination through December 31, 2022. The legislation is expected to be signed by Governor Cuomo soon. Read more online here. (Authored by Kenneth Kirschner)

Tuesday, 9 March 2021

• In the latest episode of our Talking the Cure podcast, David Horowitz, partner in the Hogan Lovells pharmaceutical & biotechnology regulatory practice area, discusses his work bringing hand sanitizers to the market in the U.S.  David explains how to understand the Food and Drug Administration's (FDA's) expectations for the guidance that opened up the hand sanitizer manufacturing market; including denaturants, impurities, and pharmaceutical grade vs. food or industrial grade ingredients. David also discusses his pre-COVID-19 regulatory over-the-counter drug work.

Thursday, 4 March 2021

• Due to the Covid-19 pandemic, which continues to impinge upon everyday life, the German Federal Ministry of Health (Bundesministerium für Gesundheit, “BMG”), after approving the distribution of point-of-care (PoC) rapid antigen tests to certain community facilities, is now also paving the way for the distribution of in-vitro diagnostics for self-testing purposes, intended for direct pathogen detection of the coronavirus SARS-CoV-2 to laypersons and, for the second time ever, is overturning the restriction for use by physicians only, which is provided for under infection control regulations. Read more online here. (Authored by Joerg Schickert)

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. Senate Democrats have opted to narrow the eligibility to receive an individual stimulus payment as part of the coronavirus relief bill, in a change that centrist Democrats had promoted. Under the proposal, individuals and couples making up to $75,000 and $150,000 per year (respectively) will receive a full $1,400 check. More than 200,000 people signed up for health coverage on federal ObamaCare exchanges in the first two weeks of a special pandemic enrollment period, according to federal statistics released Wednesday. An executive order signed by President Biden in January allows uninsured Americans to sign up for coverage on Healthcare.Gov from 15 Feb. through 15 May. On Wednesday, the Senate Finance Committee split evenly on party lines in a vote on advancing Secretary of Health and Human Services nominee Xavier Becerra. In a show of unity, Merck will help manufacture rival Johnson & Johnson’s COVID-19 vaccine. President Biden announced plans to prioritize teachers and childcare professionals for vaccines throughout March. Read more about these developments online here: and 2 Mar.; and 3 Mar. (Authored by Ivan Zapien)

• The "A Perspective" podcast is back for a fourth season, in which Andrew Skipper talks to Agility’s CEO for Africa, Geoffrey White. Geoffrey has been at the helm since 2014 and is focused on developing integrated logistics infrastructure solutions across the continent. Join them as they discuss the strategy and reasoning behind Agility’s investments into Africa, how companies in Africa can navigate infrastructure challenges through simple logistical solutions and the positive impact this is having on future growth and development. Geoffrey goes on to share his thoughts on how the AfCFTA could make a substantial difference in terms of intra-African trade and value addition and also shares his views on the main barriers to success within his business and the potential opportunities and challenges brought about by COVID-19 in the short and long term. To find out more about the future of logistics in Africa, visit Agility’s Emerging Markets page here.

Tuesday, 2 March 2021

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The U.S. surpassed 500,000 deaths from COVID-19 on Monday. The House Budget Committee met to start marking up the $1.9 trillion American Rescue Plan Act of 2021. The committee aims for the House to have a floor vote to pass the legislation by Friday or Saturday. The Senate will vote this week on a $1.9 trillion coronavirus relief bill, Senate Majority Leader Charles Schumer (D-NY) said Monday. Nearly two dozen House progressives on Monday called on Vice President Harris to overturn the Senate parliamentarian’s ruling that a $15 minimum wage could not be included in the Democrats’ $1.9 trillion COVID-19 relief package. The Senate Finance Committee will vote on the nomination of Xavier Becerra on Wednesday. Dr. Anthony Fauci on Sunday said that he would take the newly approved Johnson & Johnson COVID-19 vaccine and urged Americans to take whichever vaccine shot is available to them. The Centers for Disease Control and Prevention’s temporary eviction moratorium is unconstitutional, a federal judge ruled Thursday. On Thursday, the Food and Drug Administration (FDA) announced that it is allowing Pfizer-BioNTech COVID-19 vaccine vials to be transported and stored at normal pharmaceutical freezer temperatures for up to two weeks. Read about these developments here: 26 Feb.; 25 Feb.; and 1 Mar. (Authored by Ivan Zapien)

• As we approach the second year of the pandemic, governments and ethics councils are now grappling with the thorny issue of vaccine passports. Will we need them? Will they be reliable? Are they fair? These are familiar questions to anyone dealing with personal data because their answers have much to do with data protection. How can we make vaccine passports play a fair and safe role in our uncertain future? Online here we analyze how data protection principles can help answer ethical questions surrounding vaccine passports. (Authored by Eduardo Ustaran)

• We are now at an inflection point. COVID-19 has fast forwarded the digitalization of businesses and, following its departure from the EU, the UK now has a free hand to shape its regulatory environment. This is an opportunity to develop further a nurturing, and efficient, environment for financial technology - underpinned by gold standard regulation which maintains the perfect balance between risk management and freedom to innovate. Hogan Lovells is running a webinar series on the FinTech Strategic Review (Policy and Regulation Chapter). Our first webinar is a virtual panel discussion covering key findings from the Policy and Regulation chapter. This panel discussion will be followed by a series of webinars in the next couple of weeks focusing on Cryptoassets, Payments, Digital ID, Open Finance and Artificial Intelligence issues in the UK. Further information is available here. (Authored by Rachel Kent)

Compiled by Aaron Armstrong