COVID-19 Report for Life Sciences and Health Care Companies (July 2021)

Wednesday, 28 July 2021

• The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the drug ACTEMRA (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). ACTEMRA is not authorized for use in outpatients with COVID-19. Tocilizumab is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 (IL-6) receptor. ACTEMRA should be administered as a single 60‑minute intravenous (IV) infusion. FDA also published a fact sheet on this EUA online here. (Authored by Randy Prebula)

Wednesday, 21 July 2021

• The U.S. Food and Drug Administration (FDA) created new product codes for certain medical devices authorized for emergency use under Emergency Use Authorizations (EUAs). An applicable product code has been assigned to each authorized device category. The product codes are listed in the tables for each category of devices that have EUAs. The categories of devices are available on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices web page. The new product code should be used whenever a product code is needed or requested, such as when reporting an adverse event in a medical device report (MDR) or importing a device. FDA said in announcing the new product codes that they are important to a) ensure the FDA can adequately monitor and analyze reportable adverse events for devices granted an EUA; and b) help the FDA track imports of EUA devices. (Authored by Randy Prebula)

• The London Chamber of Commerce and Industry launched its independent dispute resolution service, the London Chamber of Arbitration and Mediation (LCAM). LCAM’s aim is to provide fast, innovative, and cost-effective mediation and arbitration services for businesses. A key feature of LCAM’s Arbitration Rules is their imposition on arbitrators of pre- and post-appointment disclosure obligations – providing parties arbitrating under the LCAM Arbitration Rules with clarity in the wake of the UK Supreme Court’s decision in Halliburton v. Chubb. Halliburton v. Chubb has brought into question whether the customs and practices in different fields of arbitration require arbitrators to disclose multiple, related appointments, or whether, in any particular field, there is already an established practice of arbitrators taking on related appointments, which would prevent the need for disclosure. LCAM's Arbitration Rules address contemporary challenges, such as restrictions on live hearings due to COVID-19, by providing for virtual hearings. We analyzed these rules online here. (Authored by Ben Hornan)

Wednesday, 14 July 2021

• The COVID-19 pandemic has led to the rapid expansion and widespread adoption of telehealth/telemedicine services, significantly altering how health care providers deliver—and how consumers access—medical services around the world. While providers laid much of the groundwork for telehealth innovation prior to the pandemic, the health crisis served as a catalyst for implementing these alternative care models on an expedited basis. Given that many of these pandemic-inspired adaptations to health care services are likely to remain in a post-COVID world, health care providers should be aware of how these changes will affect their business in order to successfully navigate this new landscape. In this article, our team discusses the latest transactions, fraud and abuse, telehealth, and privacy and cybersecurity trends impacting health care providers. (Authored by Thomas Beimers and Leigh L. Oliver)

• On 9 July 2021, U.S. President Biden signed a far-reaching executive order intended to promote competition in the American economy. Relating to health care, it orders HHS to submit a report to the White House Competition Council outlining a plan to “continue the effort to combat excessive pricing of prescription drugs . . . and to address the recurrent problem of price gouging.” This includes improving the approval framework for generic drugs and biosimilars and the standards for interchangeability of biological products so they are more transparent and predictable. The order also calls on the FDA to “work with States and Indian Tribes” that propose drug importation programs under implementing regulations that would allow for commercial importation of certain drug products. We analyzed this order in depth online here. (Authored by Chuck Loughlin and David Horowitz)

• On 7 July 2021, the New York Department of Labor (DOL) published the NY Hero Act airborne infectious disease exposure prevention standard and industry-specific model airborne infectious disease exposure prevention plans as required under the NY Hero Act. The Act requires New York employers to implement extensive new workplace health and safety protections in response to a “highly contagious communicable disease” as designated by the New York State Commissioner of Health (Designation). Notably and significantly, while the NY state Department of Health continues to deal with COVID-19 and a risk still exists, the DOL clarified that there is no current Designation for COVID-19 by the Commissioner and therefore, no New York employer is required to put a plan in effect at this time due to COVID-19. Read more online here. (Authored by Michael DeLarco)

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.

Compiled by Aaron Armstrong