Thursday, 29 April 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. On Tuesday, the Centers for Disease Control and Prevention (CDC) eased its guidelines on wearing masks outdoors, saying fully vaccinated Americans don’t need to mask up unless they are in certain crowded settings and venues. The Pfizer and Moderna vaccines were 94 percent effective in preventing hospitalization for COVID-19 among people age 65 and older, according to a CDC study released Wednesday. The Department of Labor’s Office of Occupational Safety and Health Administration (OSHA) submitted a draft of temporary workplace safety standards to prevent the spread of COVID-19 to the White House Office of Management and Budget (OMB) for review after weeks of delay; the draft safety standards were before being printed in the Federal Register. The National Institutes of Health (NIH) and CDC health officials testified yesterday before the House Energy and Commerce Committee on how the government should respond to the influx of so-called “long haulers”: Americans suffering from COVID-19 symptoms that linger for months or years after being infected. NIH is preparing to offer more than $1 billion in grants within the next three weeks to further research issue. Read more about these developments online here.  (Authored by Ivan Zapien)

• On 28 April, FDA updated the Emergency Use Authorization (EUA) Authorized Serology Test Performance page on the agency's website. FDA's Center for Devices & Radiological Health (CDRH) provided information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5 percent to 50 percent. These estimates may help health care providers interpret these antibody test results for their patients. Additionally, the updated web page clarifies the use of serology tests when assessing a patient’s adaptive immune response. (Authored by Randy Prebula)

Tuesday, 27 April 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 Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on 23 April lifted the recommended pause on the use of Johnson & Johnson’s coronavirus vaccine, saying the benefits of the shot outweigh the risk of a rare blood clot disorder. Also on 23 April, the CDC said for the first time that the agency recommends pregnant people get the COVID-19 vaccine. President Biden is expected to announce on 27 April updated CDC guidance on masking. On Monday, the Biden Administration announced it will donate millions of doses of the AstraZeneca vaccine to other countries after pressure from lawmakers and experts. Moderna announced that Sanofi will help produce up to 200 million doses of Moderna's COVID-19 vaccine starting in September. The University of California-San Francisco reported the first known case of a male in the U.S. developing a blood clot after receiving the Johnson & Johnson vaccine. Read more about these developments online here: 23 April and 26 April. (Authored by Ivan Zapien)

• On 20 April 2021, the U.S. Occupational Safety and Health Administration (OSHA) updated its FAQs with guidance stating that employers who require their employees to get vaccinated as a condition of employment may need to record employees’ adverse reactions to the COVID-19 vaccine on OSHA work-related illness logs. Importantly, the guidance also clarifies that, at this time, OSHA is exercising its discretion not to require employers to record adverse vaccine reactions if the employer recommends but does not require vaccination. OSHA will consider the vaccine to be required if employees would suffer repercussions (such as affecting an employee’s performance rating or professional advancement) due to their choice to not receive the vaccine. Read more online here. (Authored by Michael E. DeLarco)

Thursday, 22 April 2021

• On 16 April, the U.S. Department of Health and Human Services (HHS) and FDA published a notice of withdrawal of their proposal to exempt 84 medical device types – for which the normal regulatory process was temporarily waived or made more lenient during the COVID-19 public health emergency – from FDA’s 510(k) notification requirement. In its notice, FDA cited a “flawed” reliance by HHS, which issued the original notice, on FDA's Manufacturer and User Facility Device Experience (MAUDE) database for adverse event reporting. However, this withdrawal does not override the exemptions for seven class I medical devices, all of which were gloves. Read more online here. (Authored by Jodi Scott)

• 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 Biden said Wednesday that he expects the U.S. will share surplus coronavirus vaccine doses with Canada and Central American countries. Also yesterday, while touting a milestone of surpassing 200 million coronavirus vaccine doses administered on his 92nd day in office, Biden urged employers to give workers paid leave to get the COVID-19 vaccination. Federal health agencies say it could take two weeks or longer to gather and analyze enough data to conclude whether there is a link between Johnson & Johnson’s coronavirus vaccine and reports of rare but severe blood clots in recipients. The chief medical officer of BioNTech said Wednesday that people will likely need a third shot of the Pfizer-BioNTech vaccine as immunity wanes. Europe's drug regulator said Tuesday that it's recommending a warning be added to the Johnson & Johnson vaccine about a possible link to blood clots, but noted they are "very rare" and the benefits still outweigh the risks. Read more about these developments online here. (Authored by Ivan Zapien)

• On 4 December 2020, the Hong Kong Monetary Authority (HKMA) announced that it is collaborating with the Digital Currency Institute of People's Bank of China (PBOC) in a pilot testing scheme for using China's sovereign digital currency and electronic payment (DC/EP) for cross-border payments. The use of the digital currency will offer customers an additional cross-border payment option as the sovereign digital currency will soon enjoy the same status as cash in mainland China. Online here we look at what DC/EP is, explain how it works and how it compares to other digital payment products in the market, and what this collaboration means for payments in Hong Kong. With the COVID-19 pandemic and the need for social distancing, the DC/EP provides for near-contactless transactions whereby users can carry out transactions by simply tapping their phones together. (Authored by Mark Parsons)

Tuesday, 20 April 2021

• On 14 April, FDA released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency,” describing remote interactive tools the agency may use to conduct “remote interactive evaluations” of facilities during the COVID-19 pandemic. According to the guidance, remote interactive evaluations may be considered for any drug inspectional program, including Good Manufacturing Practice (GMP), Bioresearch Monitoring (BIMO), and 503B outsourcing facility inspections. Although participation in a remote evaluation will be voluntary, the guidance notes that failing to agree to a remote evaluation may “impede” timely regulatory decision making. The guidance states that FDA will use remote evaluations to meet user fee goal dates, preclude the need for a for cause inspection, and inform future inspectional priorities, among other things. Read more online here. (Authored by Jim Johnson)

• In an FDA “Voices” blog post, the agency’s Center for Devices and Radiological Health (CDRH) discussed how it has prioritized its workload since the start of the COVID-19 pandemic, touting how it has both received a record number of both standard and emergency submissions and authorized a record number of novel medical devices in 2020. The Center also has issued 10-fold more EUAs during COVID-19 than all other previous public health emergencies combined. Yet, the pandemic-related work has left CDRH with a backlog of non-COVID-19 premarket files pending review. CDRH said its biggest review challenges have been in the IVD product space, where it has delayed review of in vitro diagnostic (IVD) pre-submissions unless they are related to: a) COVID-19; b) companion diagnostics; c) a breakthrough designation request; or d) that otherwise have a “significant public health impact.” As a result, CDRH announced that for the remainder of 2021, it will be declining IVD pre-submission requests that don’t fall into one or more of these four categories. In addition, non-COVID-19 IVD premarket submissions are experiencing longer-than-typical review timelines and delays in initiation of review. However, CDRH anticipates eliminating review initiation delays on non-COVID-19 IVD files within the next 8 weeks. CDRH is also seeing review delays in non-IVD product areas: for divisions reviewing files for PPE, ventilators, and general hospital equipment, CDRH said it anticipates pre-submissions to be completed within 120 days, rather than the usual 70. Meanwhile, premarket submission reviews and pre-submissions in other product areas are generally continuing under typical timelines, “although a small number of submissions may experience delays on a case-by-case basis,” CDRH said. (Authored by Randy Prebula)

• In the latest episode of our "Talking the Cure" podcast, we speak with Suzanne Levy Friedman and Michael Penners about how both the U.S. and Germany have witnessed significant legal/regulatory activity around advertising and promotion of COVID-19 test kits. Suzanne and Michael provide an overview of those regulatory efforts, and analyze the legal authority with respect to regulating advertising and promotion of medical devices/products in the two jurisdictions. They say that one area in particular where this issue frequently arises with clients is the promotion of devices on social media.

Thursday, 15 April 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. On 13 April, the Centers for Disease Control and Prevention (CDC) and Federal Drug Administration (FDA) paused the use of the Johnson & Johnson vaccine after six women in the U.S. developed a rare blood clotting disorder within about two weeks of receiving the vaccine. White House coronavirus coordinator Jeff Zients said Tuesday that FDA's recommendation to pause the use of the Johnson & Johnson COVID-19 vaccine would not hinder the Biden Administration's distribution strategy. A panel of vaccine experts that advises the CDC was deadlocked Wednesday on whether to limit the use of the Johnson & Johnson’s vaccine based on age or sex, requiring more time to assess the risks involved. FDA released guidance on Wednesday outlining how it will conduct remote, voluntary evaluations of drug, biologic, and veterinary firms during the pandemic, and how the agency will use those findings. Denmark on Wednesday announced that it would no longer be administering Astra Zeneca’s coronavirus vaccine amid concerns on links to rare blood clots. Read more about these developments online here. (Authored by Ivan Zapien)

• In response to the economic effects of the COVID-19 pandemic and market uncertainty, a plethora of financing measures were introduced at EU level, German federal level, and German states levels. In their joint effect, these measures are aimed at shielding enterprises from the crisis by offering different liquidity programs for overbridging temporary, crisis-evoked liquidity shortages. Our note summarizes our understanding of the key EU, German federal, and German states’ financial and state aid measures. This note includes updates to our initial version published on 1 April 2020, which relate, among other things, to the criteria of KfW-Sonderprogramm 2020 and the relevant financing products available on German state levels. Questions remain about the scope of some of these measures. (Authored by Katlen Bloecker)

Tuesday, 13 April 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. Congress returns this week from their two-week spring recess. The Senate will continue its consideration of President Biden’s health care nominees. President Biden released his $1.52 trillion FY 2022 discretionary budget request on 9 April, focusing on domestic programs. The HHS budget request asks Congress to anticipate the next pandemic and provides more than a 23 percent increase for HHS over the 2021 enacted level. On 15 April, HHS Secretary Xavier Becerra will testify before the House Appropriations subcommittee on the FY fiscal 2022 HHS budget request. Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky told reporters on 7 April that the highly contagious B.1.1.7 variant is now the main form of COVID-19 in the U.S. A late-stage clinical trial of 1,500 people suggests that the antibody cocktail made by Regeneron reduced the risk of symptomatic COVID-19 by 81 percent in people living with a person infected with the virus, the company said Monday. Read about these developments online here. (Authored by Ivan Zapien)

• On 9 April, the U.S. Food and Drug Administration (FDA) recommended that health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators currently available to facilitate this transition, FDA and CDC said they believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. FDA recommends that health care personnel and facilities: (1) limit decontamination of disposable respirators, as decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new FFRs or if you are unable to obtain any new respirators; (2) transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other FFRs; and (3) increase inventory of available NIOSH-approved respirators — including N95s and other FFRs, elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room, and powered air-purifying respirators (PAPRs). (Authored by Randy Prebula)

• On 6 April 2021, the U.S. Department of Labor Secretary Marty Walsh placed a “hold” on the implementation of a potential U.S. Occupational Safety and Health (OSHA) COVID-19 Emergency Temporary Standard (ETS), which would set a national COVID-19 safety standard for OSHA-covered employers throughout the United States. While President Biden’s inauguration day Executive Order directed OSHA to focus its enforcement on COVID-19 efforts and set a 15 March deadline for determining whether an ETS was necessary and issuing it, Secretary Walsh stated that any ETS needs to “reflect the latest scientific analysis of the state of the disease” and is delaying its implementation until such scientific review is completed. At this time there isn’t any more information regarding how long the review period will last, and we don’t yet know when (if?) an ETS will ultimately be issued. That said, Walsh ordered a “rapid update based on [CDC] analysis and latest information regarding the state of vaccinations and the variants” stating that it would hopefully be turned over to the “next level” (presumably the White House’s Office of Information and Regulatory Affairs for review) “very soon.” (Authored by George W. Ingham)

Thursday, 8 April 2021

• Our Asia Pacific Data Protection and Cybersecurity Guide 2021 will take you through the developments and key initiatives of APAC countries and discuss the implications of an ever-shifting landscape. Our Guide discusses (1) the impact of COVID-19 on data protection and cybersecurity in APAC; (2) key legislative and regulatory developments in 2020 and looking forward into 2021; (3) APAC data protection regulatory heat map; and (4) individual country data protection developments. Online here you can download the full version of the Asia Pacific Data Protection and Cyber Security Guide 2021 and the Snapshot of our APAC data protection and cybersecurity practice. (Authored by Sherry Gong)

• On Tuesday, the U.S. Food and Drug Administration (FDA) granted its first emergency use authorization (EUA) to an at-home serology test. Symbiotica Inc.’s prescription-only COVID-19 Self-Collected Antibody Test System permits people 18 and older to use a fingerstick to collect their own blood sample, and an adult must collect a sample for people ages 5 to 17. However, FDA said the Symbiotica test “should not be used to diagnose or exclude acute SARS-CoV-2 infection” because “[a]t this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.” (Authored by Randy Prebula)

• In the U.S. Consolidated Appropriations Act, 2021, are significant changes to intellectual property law and practice, touching upon trademarks, copyrights, patents, domain names, false advertising, and more. Owners of these assets and those with an interest in enforcing in these fields must take note of the changes. We analyze the copyright implications of the U.S. appropriations law online here, and the trademark and brand implications online here. (Authored by Anna Shaw)

• On 12 March 2021, U.S. President Biden signed the American Rescue Plan Act (ARPA) into law, aiming to provide relief to individuals and businesses suffering from the COVID-19 pandemic. ARPA impacts employer-sponsored health plans in several ways, including the implementation of a COBRA premium subsidy. Employers should be aware of the actions they must take in response to this change, which we analyzed online here. (Authored by Kurt L.P. Lawson)

Tuesday, 6 April 2021

• The U.S. Food and Drug Administration (FDA) said last week that it is concerned that virus mutations could lead to false results with certain COVID-19 tests, and that it has found some tests are prone to lower sensitivity, publishing a new FDA webpage that aggregates information to spotlight concerns about mutations that could lead to lower test sensitivity and false results. FDA singled out four molecular tests that have been given emergency use authorization (EUA) that may be prone to giving false results due to emerging mutations. Separately, FDA authorized several over-the-counter (OTC) COVID-19 antigen tests for use without a prescription on Thursday, offering a way for schools, workplaces and other groups to conduct rapid screening. Rapid antigen tests will be especially useful for serial testing, which involves "testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test," FDA said. FDA has also indicated in public meetings that additional OTC submissions are under review. (Authored by Randy Prebula)

• New York state passed legislation on 12 March 2021 to provide employees in the state with up to four hours of paid leave for each COVID-19 vaccination injection they receive. On 21 March, the New York Department of Labor released Frequently Asked Questions (FAQs) that clarify several aspects of the new NY paid vaccination leave law; for example, if an employee took time off to get the COVID-19 vaccination prior to 12 March, employers may voluntarily provide paid leave benefits, but the new law does not require employers to provide the benefits retroactively. We analyze these new clarifications online here. (Authored by Kenneth Kirschner)

• On 19 March 2021, California Governor Newsom signed into law SB 95 (adding sections 248.2 and 248.3 to the Labor Code), which requires employers to pay California employees up to two weeks of COVID-19 supplemental paid sick leave (COVID-19 SPSL). This new law revives and expands the supplemental paid sick leave law that expired on 31 December 2020. As a result of these changes from the prior iteration of California’s Supplemental Paid Sick Leave law, many more California employers will be required to provide, and many more employees will be eligible for, COVID-19 SPSL. We analyze the new law online here.  (Authored by Tao Leung)

Compiled by Aaron Armstrong