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COVID-19 Report for Life Sciences and Health Care Companies (14 - 17 December 2020)
15 December 2020
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.
Thursday, 17 December 2020
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The U.S. Food and Drug Administration (FDA) has stated publicly that the agency has received more than 5,000 device-related Emergency Use Authorization (EUA) submissions. Yet, they have authorized 404 devices this year (not counting vaccines and drugs or biologics), meaning that they have acted on less than 10% of everything they have received. A full 60% of EUAs that have been authorized are for diagnostic tests of various types (although the number of Laboratory Developed Test (LDT)-related EUAs dropped to zero in October when FDA changed its prioritization of diagnostic reviews). Another 20% are for ventilators (and from early in the pandemic), which makes sense given the paramount ventilation needs of critically ill patients. Despite two surges in cases, however, there has not been a concordant spike in authorizations. Similarly, there seems to be no urgency at FDA to authorize more protective equipment or PPE reprocessing requests. (Authored by Randy Prebula)
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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 “four corners” — House Speaker Nancy Pelosi (D-CA), House Minority Leader Kevin McCarthy (R-CA), Senate Minority Leader Chuck Schumer (D-NY), Senate Majority Leader Mitch McConnell (R-KY) — are reportedly very close to a deal with the White House on a roughly $900 billion coronavirus relief package as negotiations continue. The negotiations come after a bipartisan “908 coalition” unveiled summaries and text of their $908 billion coronavirus relief proposal that has now been divided into two sections to allow the House and Senate to vote on the controversial and noncontroversial sections separately. Federal officials had to return several thousand doses of Pfizer's coronavirus vaccine in two different states after they became too cold during the transport process. FDA staff have endorsed Moderna’s coronavirus vaccine in its report to the agency’s Vaccines and Related Biological Products Advisory Committee. The committee will be meeting this week, and is expected to recommend the vaccine for emergency use authorization. Read about these and other updates here: 15 Dec. and 16 Dec. (Authored by Ivan Zapien)
Tuesday, 15 December 2020
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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. A bipartisan group of lawmakers is splitting its $908 billion coronavirus relief proposal into two packages. The plan reportedly will include a $160 billion proposal that ties together the two most controversial elements: more money for state and local governments and liability protection. The second proposal will total $748 billion and include less controversial ideas, including another round of Paycheck Protection Program funding for small businesses, unemployment benefits, and more money for vaccine distribution, testing, and schools. The first COVID-19 vaccinations in the U.S. began Monday morning. Sens. Josh Hawley (R-MO) and Bernie Sanders (I-VT) are warning they will use Friday's government funding deadline to try to force a vote on a second round of stimulus checks in another coronavirus relief package. Read about these and other updates here: 10 Dec.; 11 Dec.; and 14 Dec. (Authored by Ivan Zapien)
Compiled by Aaron Armstrong
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