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

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

In Tuesday's Report: Analysis of Trump's "Buy American" order, CDRH publishes FY-2021 guidance plan, Fauci advises on U.S. lockdown options, and a video on the fragmented pandemic response in the U.K.

Tuesday, 20 October 2020

  • President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for both domestic and foreign companies. Legitimate concerns exist about U.S. dependency on drugs, medical devices, and supplies manufactured abroad, and the COVID-19 pandemic has brought them into sharp focus. The executive order aims to address these concerns by extending advantages in U.S. government purchasing to essential drugs, critical countermeasures (such as certain devices and personal protective equipment), and critical inputs (such as raw materials and components) that are made in the U.S. Read more here. (Authored by Joy Sturm)

  • On 16 October, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021). FDA also announced it is committing to review previously published final guidance documents, and updating or deleting guidance documents that no longer represent FDA’s current thinking on a regulatory issue. There are priority draft guidance documents listed that appear to flow from challenges faced during the COVID-19 pandemic, including the “Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization (EUA) During the COVID-19 Public Health Emergency,” and a forthcoming guidance related to “Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act.” Read more about CDRH's FY-2021 priorities online here. (Authored by Lina Kontos)

  • 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. House Speaker Nancy Pelosi (D-CA) set a Tuesday deadline for her and Treasury Secretary Steven Mnuchin to reconcile significant policy disputes if they want to pass a relief bill before Election Day. On Monday, Pelosi and Mnuchin spoke for nearly an hour; according to a Tweet from Pelosi’s spokesperson, Drew Hammill, they continued to “narrow their differences” and will continue talks. Senate Majority Leader Mitch McConnell (R-KY) over the weekend announced that the Senate would vote on an additional round of funding for the Paycheck Protection Program (PPP) on Tuesday and then would revote on Wednesday on a US$500 billion stimulus program which was blocked in September. Senate Democrats are calling on congressional leadership to implement an updated coronavirus testing plan at the Capitol after a recent outbreak. Dr. Anthony Fauci, the government’s top infectious disease expert, says that a nationwide lockdown may not be the best COVID-19 solution even as cases rise during the fall and winter. Coronavirus hospitalizations across the U.S. had increased by 5 percent in 37 states as of Sunday, according to a CNBC analysis of data collected by the COVID Tracking Project. The U.S.-Canada and U.S.-Mexico borders will remain closed to all non-essential travel until 21 November, the U.S. Homeland Security Department said Monday. Read about these and other updates here: Oct. 15, Oct. 16, and Oct. 19. (Authored by Ivan Zapien)

  • "The Legacy of Lockdown: Making law and policy post COVID-19" is a series of videos created by our Public law and policy team on how the UK Government’s response to the coronavirus pandemic is accelerating changes in the way it goes about governing. In our latest video, Dervla Simm and Andrew Eaton discuss how the response to the coronavirus pandemic has been fragmented across the different parts of the UK and what this means for UK businesses now and in the future. Each government seems to be forging its own path and taking its own scientific advice. The scale of the pandemic has in many ways empowered the devolved administrations, and with many more powers returning to the devolved administrations, due to Brexit, there is potential for yet more divergence across the UK. The implications of devolved decision making for individuals and businesses are now bigger than ever.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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