To see how Hogan Lovells advised Lucira Health in obtaining the first FDA Emergency Use Authorization for an at-home COVID 19 testing kit - CLICK HERE.
- Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority Whip Jim Clyburn (D-SC) ran unopposed and were approved by the caucus to serve in those roles next year. House Democratic Caucus Chair Hakeem Jeffries (D-NY) did not face any competition for his post as the fifth-ranking leader, and was reelected on Wednesday. For the fourth-ranking post, assistant speaker, Rep. Katherine Clark (D-MA), defeated Rep. David Cicilline (D-RI). Representatives Tony Cardenas (D-CA) and Sean Patrick Maloney (D-NY) are vying to run the House Democrats’ campaign arm after Rep. Cheri Bustos (D-IL) announced that she would run again. Republicans reelected Kevin McCarthy (R-CA) as its Majority Leader. Rep. Steve Scalise (R-LA) will serve as minority whip, and Rep. Liz Cheney (R- WY) will remain House GOP Conference chair.
- The Food and Drug Administration provided an Emergency Use Authorization (EUA) for an at-home rapid test developed by Lucira Health. The kit allows people to swab test themselves outside of a lab or health care setting and obtain results in 30 minutes with a 94 percent accuracy rate on positive results. Lucira turned to Hogan Lovells’ Medical Device & Technologies regulatory practice to assist in obtaining the EUA. The company will next file for over-the-counter (OTC) authorization, which will allow the tests to be sold at pharmacies and grocery stores, without a prescription, for under $50.
- House Speaker Nancy Pelosi and Senate Minority Leader Schumer sent a letter to Majority Leader Mitch McConnell inviting him to the negotiating table on COVID relief legislation. The letter noted that Secretary Mnuchin and Chief of Staff Meadows had entered into a good faith agreement with Democrats to compromise on a relief package and lowered their request by $1.2 trillion. The leaders also mentioned that McConnell called for a relief bill during the lame-duck session and “it’s a possibility we will do more for state and local governments” while pointing out that he has now lowered his proposal from $1 trillion to $500 billion.
- President-elect Joe Biden says that the General Services Administration (GSA) official refusing to start transition is slowing down his efforts to fight the coronavirus and could set back the effort to distribute a coronavirus vaccine by “weeks or months.” Biden says that it is the only obstacle preventing the transition from beginning. “We’ve been unable to get access to the kinds of things we need to know about -- the depth of the stockpiles, we know there’s not much at all,” Biden said in a virtual meeting with front-line workers. Biden said the administration still has not share its plan for distributing a vaccine. “And there’s a whole lot of things that we just don’t have available to us, which unless it’s made available soon, we’re going to be behind by weeks or months,” he said.
- Today, Health and Human Services (HHS) Secretary Alex Azar split with the White House asking the public to follow the Centers for Disease Control and Prevention‘s (CDC) guidance by staying home this Thanksgiving and avoid gathering indoors with people that don’t reside in the same household. “Gathering indoors with people who aren’t members of your household is a high-risk activity for spreading the virus,” Azar said.
- U.S. Sen. Cory Booker (D-NJ) introduced legislation Wednesday to provide state and local districts across the country more than $260 billion in additional federal aid to support their response to the coronavirus pandemic. The “Educator Jobs Fund Act of 2020,” would create a new grant program to pay teachers’ salaries, recruit and train new educators, provide more personal protective equipment (PPE) for schools and support grants for partnerships and teacher and school leader preparation programs.
In the News:
- More than 900 staffers at the Mayo Clinic have contracted COVID-19 in the past two weeks, the system's dean of clinical practice says.
- Early research indicates that COVID-19 infection might result in immunity that could last for six months and possibly much longer. The study included 185 adults, ages 19 to 81, in the United States who had recovered from Covid-19. The new study has not been peer-reviewed or published in a scientific journal.
- New cases have surged to an all-time high at nursing homes across the country despite federal efforts to shield residents through aggressive testing and visitor restrictions, a new report shows.
- Montana Gov. Steve Bullock announced a new round of directives Tuesday, limiting crowd size and close bars, restaurants, and casinos at 10 p.m.
- Los Angeles County imposed new restrictions on businesses Tuesday and is readying plans for a mandatory curfew for all but essential workers if coronavirus cases keep spiking.
Authored by Ivan Zapien