COVID-19 Report for Life Sciences and Health Care Companies (16 - 19 November 2020)

Thursday, 19 November 2020

• The European Medicines Agency (EMA) published a list containing all COVID-19 treatments and vaccines that have, thus far, been the subject of scientific advice or informal guidance from EMA’s pandemic Task Force. This initiative is part of the EMA’s efforts to implement extra transparency measures in relation to the review of COVID-19 medicinal products. The EMA will update this list on a monthly basis. Read more here. (Authored by EA Wright)

• The U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically used to signal enforcement priorities – “to highlight certain inherent risks” of remuneration related to speaker programs sponsored by drug and device companies, and to advise firms to consider the inherent risks of speaker programs as they evaluate whether and how to resume in-person speaker programs that have been curtailed during the COVID-19 pandemic. While the OIG alert itself may not be altogether surprising in light of numerous speaker program-related settlements with drug and device manufacturers in recent years, several of which have resulted in restrictions as well as outright prohibitions on speaker program activity, the Special Fraud Alert marks the OIG’s clearest signal to date that speaker programs will be subject to continuing, and potentially heightened, enforcement scrutiny and that manufacturers should seriously reconsider their use. Read more here. (Authored by Ron Wisor)

• 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 of Representatives re-elected Rep. Nancy Pelosi (D-CA) as Speaker of the House. Hogan Lovells advised Lucira Health in obtaining the first U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for an at-home COVID-19 testing kit. President-elect Joe Biden says that the General Services Administration (GSA) official refusing to start transition is slowing down his efforts to fight coronavirus and could set back the effort to distribute a coronavirus vaccine by “weeks or months.” Sen. Chuck Grassley (R-IA) has tested positive just one day after speaking on the Senate floor. FDA Commissioner Stephen Hahn pledged that FDA would make more data available and increase transparency about why it is authorizing certain COVID-19 vaccines and drugs. Read about these and other updates online here: 17 Nov.; 18 Nov. (Authored by Ivan Zapien)

Tuesday, 17 November 2020

• In the latest episode of our "Talking the Cure" Podcast, Randy J. Prebula, Susan D. Tiedy-Stevenson, and Erkang Ai, Ph.D. discuss the world of in vitro diagnostics (IVD), the current SARS-CoV-2 situation, and the various IVDs that are being granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).

• 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 Monday, Moderna announced that its coronavirus is 94.5% effective against COVID-19 in its phase three testing. NIH official Dr. Anthony Fauci told NBC’s Today Show on Monday said that he's "concerned" about the stalled transition process between President Trump and President-elect Biden. Fauci specifically highlighted the need for a "smooth process" for approving and distributing a COVID-19 vaccine. More than 16 GOP governors rejected President-elect Joe Biden’s suggested statewide mask mandates in order to curb the pandemic, even though their states are seeing a massive surge in new outbreaks and despite new CDC guidance emphasizing the importance of masks for both wearer and surrounding people. Testing labs processing COVID-19 tests are concerned that there will be a delay in testing and supply chain shortages as the U.S. continues to see a mounting number of cases. Read about these and other updates here: 16 Nov.; 13 Nov.; 12 Nov. (Authored by Ivan Zapien)

• In an article for Lexis®PSL, Duncan Gorst and Josh Redman discuss the relationship between insolvency and arbitration. They consider the impact coronavirus has had on insolvency and arbitration as well as issues parties should consider when bringing arbitration proceedings against parties at risk of insolvency. The analysis focuses on arbitrations subject to the law of England and Wales, and, unless stated, with an English seat.

Compiled by Aaron Armstrong