Wednesday, 7 July 2021

• Last week, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Personnel and Facilities  entitled, "FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators," through which FDA revoked the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (effective 6 July 2021) and for decontamination and bioburden reduction systems (revocation effective 30 June 2021). As of the effective dates of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the 27 May 2021 letter in which the FDA recommended a transition away from non-NIOSH-approved disposable respirators as well as from reusing decontaminated or bioburden-reduced disposable respirators. The letter also includes important information about the supply of NIOSH-approved respirators, including information on the domestic supply of NIOSH-approved respirators; recommendations for health care personnel; actions FDA has taken; updates on related information from government partners such as CDC/NIOSH and OSHA; and instructions for reporting problems with a device to FDA. (Authored by Randy Prebula)

• The COVID-19 pandemic put a spanner in the works of antitrust enforcement and, for quite some time, brought matters to a grinding halt in many jurisdictions. Thanks to the availability of effective vaccines, we might now be seeing some light at the end of the tunnel – which, in turn, gives rise to the question: what must companies expect in antitrust enforcement as the pandemic recedes? In this article, Hogan Lovells’ Global Cartel Investigations Group sketches out its views on likely trends in post-pandemic antitrust that are expected to shape antitrust enforcement in the coming years and what this means for companies. This is based on the bundled expertise and trend-spotting efforts of our Global Cartel Investigations Group at Hogan Lovells, distilled into key topics which translate to six capabilities companies around the globe should leverage to successfully navigate the post-pandemic world of antitrust. (Authored by Christian Ritz)

• The advent of the COVID-19 virus and related shut-downs that commenced in early 2020 have had a dramatic impact on commercial real estate throughout the United States and resulted in numerous high profile lawsuits. Commercial tenants have attempted to escape lease obligations through force majeure and related legal arguments, with commercial landlords resisting such efforts and seeking enforcement of their commercial leases through the court system. This article looks at some key commercial lease decisions across the U.S. a year-and-a half into the COVID-19 crisis. (Authored by Michael Turrill)

• In last week's episode of our Talking the Cure podcast, Lowell M. Zeta, who just rejoined Hogan Lovells after serving as Senior Counselor to the Commissioner at FDA, speaks with Philip Katz about his work on cross-cutting and high-priority initiatives promoting innovation and addressing public health issues, including the U.S. COVID-19 pandemic response.