Wednesday, 24 November 2021

• On 15 November, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed tests (LDTs) developed by high complexity clinical laboratories, including LDTs for diagnosis of COVID-19. In the statement announcing this change, HHS Secretary Xavier Becerra said that the withdrawal is intended to help “ensure that COVID-19 tests are accurate, reliable, and available.” FDA also recently updated its emergency use authorization (EUA) policies for COVID-19 tests. In the updated policy, FDA expects newly offered COVID-19 tests, including LDTs, to have an EUA, or traditional marketing authorization such as a granted De Novo or cleared 510(k) Notice, prior to clinical use. We have summarized these changes online here. (Authored by Randy Prebula and Brooke Bumpers)

• The current transition out of the COVID-19 pandemic and withdrawal of financial support provided by governments to cope with the pandemic is likely to lead to an increasing stream of entities that need to go through some form of financial restructuring. It may take time for these situations to be resolved, whereas the need of cash is often urgent. To address this need, the EU Directive on preventive restructuring frameworks, which we have analyzed online here, introduced harmonized mechanisms to provide lenders with more comfort lending into distressed situations. (Authored by Astrid Zourli and David Simonds)

• No country, business, organization or individual has been unaffected by the COVID-19 pandemic. This is also true for competition law and, in particular, cooperation and collaboration arrangements between competitors (co-opetition) to address challenges created by the pandemic. This article surveys the guidance given, and other actions taken, by multilateral organizations and individual competition authorities in relation to these arrangements. It also looks at the impact this experience is likely to have in the future as the worlds starts to return to the - new - normal. (Authored by Rachel Brandenburger)

• Last week, FDA amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. On Monday, FDA issued an update to the Resiliency Roadmap for FDA Inspectional Oversight, which was originally published in May 2021. Yesterday, FDA added an electronic clinical thermometer to the list of Discontinued Medical Devices During the COVID-19 Public Health Emergency: the Tympanic Temperature Module manufactured by Philips Medizin Systeme Böblingen GmbH’s. The agency also authorized yesterday three over-the-counter (OTC) COVID-19 antigen diagnostic tests: the InBios SCoV-2 Ag Detect Rapid Self-Test, the Access Bio CareStart COVID-19 Antigen Home Test, the Becton, Dickinson and Company BD Veritor At-Home COVID-19 Test. (Authored by Randy Prebula)

• While the U.S. Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for drug manufacturers that report prices into the Medicaid Drug Rebate Program (MDRP) and the Medicare Part B programs, respectively. The Centers for Medicare and Medicaid Services (CMS) finalized its proposal to delay the effective date of changes to the regulatory definition of “best price” at 42 C.F.R. § 447.505(a), which will expressly enable the reporting of multiple BPs for  value-based purchasing (VBP) arrangements; we have analyzed this change online here. CMS’s stated purpose of the delay is “to provide more time for CMS, states, and manufacturers to make the complex system changes necessary to implement the new BP and VBP program, and assure patient access and quality of care, given the current need to devote resources to the public health emergency (PHE) relating to COVID-19 that has been in effect, and will likely remain in effect at least through 2021.” (Authored by Alice Valder Curran and Ken Choe)

Wednesday, 17 November 2021

• As we first reported here, on 5 November 2021, the U.S. Occupational Safety and Health Administration (OSHA) published its long-awaited Emergency Temporary Standard (ETS) requiring private sector employers with 100 or more employees to mandate COVID-19 vaccination or weekly testing for employees. A federal court of appeals in Louisiana has temporarily stayed the OSHA COVID-19 vaccine-or-test mandate for larger employers. Online here we address what to expect next from U.S. courts interpreting the OSHA ETS and how covered employers can protect their interests in the meantime. (Authored by Sean Marotta)

• On 12 October 2021, a court in the Northern District of New York preliminarily enjoined the New York State Department of Health’s (DOH) COVID-19 vaccination rule for health care employees to the extent it required employers from denying religious exemptions. On 4 November, the United States Court of Appeals for the Second Circuit reversed the injunction, leaving the DOH’s rule intact. However, the Second Circuit’s opinion makes clear that the NY vaccination rule does not eliminate employers’ obligations to consider accommodations for religious objectors. We have analyzed this case online here. (Authored by Michael DeLarco)

• Online here, our new Asia insurance regulatory tracker for Q1/Q2 2021 covers a range of developments occurring as a result of the COVID-19 pandemic, including a decision by the Chinese authorities relaxing the rules for foreign investment in life insurance companies, a new guideline issued by the Hong Kong Insurance Authority on group supervision, regulatory amendments published by the Singaporean authorities in relation to the United Kingdom – Singapore Free Trade Agreement, and proposed amendments to the Law on Insurance Business by the Vietnamese authorities. (Authored by Andrew McGinty)

Wednesday, 10 November 2021

• On 4 November 2021, the U.S. Occupational Safety and Health Administration (OSHA) announced its long-awaited Emergency Temporary Standard (ETS) that requires employers with 100 or more employees, among other things, to mandate COVID-19 vaccination or weekly testing for most of their employees. The ETS became effective upon publication in the Federal Register on 5 November 2021. The deadline for employees to receive their final vaccine dose or begin testing is 4 January 2022; other requirements go into effect 6 December 2021. We summarized online here key features of the OSHA ETS — including how it interacts with the vaccine mandate for federal government contractors and a new rule promulgated by the Centers for Medicare and Medicaid Services (CMS) requiring vaccines for health care workers in Medicare and Medicaid certified facilities — and discuss next steps for employers covered by the ETS. (Authored by George Ingham)

• On 1 November 2021, the Biden Administration issued several new frequently asked questions (FAQs) for federal contractors subject to the President’s executive order mandating COVID-19 vaccinations for covered contractor employees. Among other things, the latest FAQs clarify that contractors will have some flexibility on the vaccination deadline for employees with pending accommodation requests and that contractors that fail to achieve perfect compliance are unlikely to face significant penalties so long as they are engaged in good faith compliance efforts. We've summarized these FAQs online here. (Authored by William Ferreira)

• The U.S. Food and Drug Administration (FDA) posted an updated template to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. The template online here includes updated recommendations and additional clarity for test developers, and is intended to help test developers provide validation data and other information to FDA. Last week, the agency also authorized another over-the-counter (OTC) COVID-19 test: FDA issued an emergency use authorization (EUA) for the iHealth COVID-19 Antigen Rapid Test, an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. (Authored by Randy Prebula)

Wednesday, 3 November 2021

• An expert panel advising the U.S. Centers for Disease Control and Prevention (CDC) recommended Tuesday that Pfizer’s pediatric vaccine should be used in children ages 5 to 11. The recommendation now goes to CDC Director Rochelle Walensky for final approval. Last week, the U.S. Food and Drug Administration (FDA) had authorized two shots of the Pfizer-BioNTech vaccine, but with just one-third of the active ingredient, for children five through 11 years old. The two shots are to be administered three weeks apart, just like in adults. Over the past week, the U.S. Department of Health and Human Services (HHS) has also announced several measures to accelerate access to COVID-19 testing:

  • The National Institutes of Health (NIH) is investing $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with FDA. NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative.

  • FDA is further streamlining the regulatory pathway for manufacturers developing over-the-counter (OTC) at-home tests. FDA is providing recommendations for labeling updates to facilitate OTC single-use testing for symptomatic individuals for tests currently authorized only for serial testing. The developers of those tests will now be able to request authorization to add single-use testing for symptomatic individuals without submitting additional data. 

  • FDA announced it has authorized another OTC rapid antigen test. FDA has granted an emergency use authorization to Celltrion Diatrust for its COVID-19 Home Ag Test for over-the-counter single-use testing for symptomatic adults and over-the-counter serial testing for all adults.

  • FDA also issued an emergency use authorization (EUA) for the Detect Covid-19 Test, an OTC COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour.

  • FDA reissued the EUA for the OraSure Technologies InteliSwab to authorize its use as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms and as a single use test with a prescription for symptomatic people who are suspected of COVID-19 by their health care provider.

  • The CDC released its “ACIP Evidence to Recommendations for Use of COVID-19 Vaccine Booster Doses” document, along with its information on additional dose for immunocompromised people.

  • In addition, the U.S. government has purchased 614,000 additional doses of the Eli Lilly COVID-19 antibody therapy for $1.29 billion. (Authored by Randy Prebula)

• Online here we have analyzed whether European employers may ask employees to work from home if they cannot show a valid QR code demonstrating proof of vaccination. In sectors in which a coronavirus access card have been compulsory for visitors and customers since 25 September 2021, there is explicitly no legal obligation for employees to show a valid QR code. Incidentally, European regulators are currently exploring legislation that would allow the exception for certain categories of employees to lapse under certain conditions.  (Authored by Anita de Jong)

Compiled by Aaron Armstrong