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COVID-19 Update
June 11, 2020

IowaBio wants to provide our members useful information during the COVID-19 pandemic. This newsletter compiles information on state, federal and industry action to combat the virus and its impacts.

If your company is helping respond to COVID-19, IowaBio wants to know about it. Please, send any information about what your biotechnology company or organization is doing to help, to Jessica Hyland at Jessica@iowabio.org.

If IowaBio can assist you in getting information out, connecting with public officials, or support your company in another way, please do not hesitate to reach out.

Past IowaBio COVID-19 Update newsletters are now available at www.iowabio.org/COVID19 and can be found under the Industry News tab on the IowaBio website.
 
Iowa Update
 
Currently, IDPH has reported on the state’s coronavirus dashboard, 22,733 Iowans have tested positive, up 297 from our update yesterday morning, with a total of 206,032 tested.  9 more deaths were reported since our update yesterday, bringing the total to 638 deaths.  Now 13,801 Iowans have recovered. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.
 
Yesterday the Governor announced that effective Friday June 12 the 50 percent capacity limits for businesses will be removed, but social distancing of 6 feet will be retained for restaurants, bars, theaters and gyms. Establishments still must reduce risk of transmission of COVID-19 using public health guidance issued by IDPH. The restriction will lift at 8 a.m. Friday, according to Gov. Kim Reynolds' latest proclamation.  All businesses must continue to adhere to reasonable social distancing, increased hygiene practices and other public health measures. 
 
Yesterday the Iowa State Fair Board voted by secret ballot 11-2 to cancel the state fair for 2020.
 
Governor Reynolds said at her press conference yesterday, the testing mark now exceeds 200,000 people, and some are now getting repeat tests. Overall hospitalization rates have continued to trend down, she said. She said they are continuing to build PPE supplies. 60 percent of people with COVID-19 have recovered. 11 long term care facilities have been removed from outbreak list with no new cases for 28 days.
 
Testing capacity has continued to expand through providers and Test Iowa. Test Iowa has tested 36,000 Iowans since April 25, and 25,000 since May 2. Five new Test Iowa sites were announced Monday. They plan to open additional clinic sites next week to further expand testing in rural communities. On Monday, the Des Moines and Cedar Rapids sites will be moving to different sites in the same community. For a list of Test Iowa sites click here.
 
Dr. Caitlin Pedati, State Epidemiologist, spoke about guidance for reopening. She said as they dial back on some of the mitigation strategies, it’s important for Iowans who fall into a high-risk group such as older Iowans or those with underlying conditions should avoid group settings and stay home as much as possible. She urges people to quarantine when exposed or to stay home when feeling sick. Social distancing and frequent hand washing, as well as mask-wearing will help limit spread. Masks should not be touched and need to be washed after each use. IDPH and the dashboard will have guidance posted.
 
Late last night the Iowa Senate debated and passed COVID-19 liability protections for businesses 31-18, along party lines. The bill provides extensive protection against civil liability for COVID-19 for businesses and health care providers. It also provides protection for those who donated equipment, hand sanitizer or PPE. The bill contains a number of important provisions designed to protect businesses from lawsuits due to COVID-19, while still allowing litigation to proceed against those who would intentionally harm someone, act with reckless disregard or act with actual malice.
 
The bill:
  • Requires that individuals bringing suit meet minimum medical conditions, in this case hospitalization or death.  It also must be proved that the defendant in the case acted in a way that was intended to cause harm or acted with malice.
  • Provides protections from liability lawsuits to persons in control of a facility unless that person recklessly disregards risks or acts with malice.
  • Provides protection from lawsuits if the business was in compliance with federal or state regulations, orders or guidance.
  • Provides protection from lawsuits to health care providers as their industry rapidly reacted to respond to COVID-19, treating patients with the virus, while other services and procedures were suspended.
  • Provides protection from lawsuits to those involved in providing products like disinfectants and face shields needed to fight the virus unless the person disregarded a substantial or unnecessary risk or acted with malice.
  • Contains language making the bill’s provisions retroactive to cover the entire period of the potential presence of the coronavirus COVID-19 in Iowa (January 1, 2020)
The bill now goes to the Governor.

Federal Legislation
Supplemental IV
Timeline/Process/Politics: Bipartisan negotiations have yet to begin, and Republicans are still putting together priorities. Leader McConnell likely won’t bring another COVID-19 supplemental to the floor until mid-July. If we consider how protracted the debate on the last bill was, negotiations may need a backstop like August recess to provide adequate pressure to move through the House and Senate.
 
Policy: Republicans continue to push for liability protections and are working on strategies to combat the incentive structure of the federal boost to unemployment insurance. While the Heroes Act will not be taken up by the Senate (as Sen. McConnell has indicated), it can serve as an outline of Democratic priorities. Heroes Act text (as of 5/12/2020) here. Section by section here. One pager here. State and Local one pager here. NCAI’s summary on tribal provisions here. Manager’s amendment here. House Rules Committee report here.
 
Legislation to Watch
Prioritized Paycheck Protection Program (P4) Act
Senators Coons (D-DE), Shaheen (D-NH), and Cardin (D-MD) released a PPP bill that would allow some small businesses to get a second PPP loan. One-pager here.
 
The forgivable PPP loans would be available to small businesses and nonprofits who are still suffering from the pandemic/recession. Highlights below:
  • Applicants would have to show that business activity is still down at least 50 percent.
  • Loans would be capped at $2 million or 250 percent of monthly payroll costs.
  • Loans would not be available to publicly traded companies.
Passed Legislation

 New Implementation Information and Guidance
  • 6/9 – SBA released updated stats on the PPP program. The numbers below are cumulative from all dollars distributed through PPP from both CARES and the interim package. See below:
    • Number of approved loans: 4,537,774
    • Total dollars: $511,418,969,219
    • Total Lenders: 5,455
    • Average Loan Size: $112,702
  • 6/9 – HHS announced additional distributions from the CARES Act to Medicaid and CHIP providers. HHS will distribute $15 billion to eligible providers that have not received a payment from the Provider Relief Fund General Distribution. HHS also will distribute $10 billion to safety net hospitals, which will receive the distribution this week. Press release here.
Oversight Update
Oversight Commission
One of the four members of the Congressional Oversight Commission established under the CARES Act, Bharat Ramamurti has recently tweeted articles that have highlighted corporations and hospitals receiving money from the federal government and promptly laid off workers or cut pay of workers. Ramamurti warned that “this is what happens when you give big corporations money with no strings attached.”
 
The commission, which also includes Sen. Pat Toomey (R-PA), Rep. Donna Shalala (D-FL), and Rep. French Hill (R-AR) is still without a Chairman, which requires a joint selection by Speaker Nancy Pelosi and Senator Mitch McConnell.
 
Paycheck Protection Program and Economic Stimulus
Criminal investigators at the IRS are seeing a “cornucopia of fraud” as the pandemic drags on and trillions of dollars in aid has flowed out of the federal government, a top official said last week. Much of the uptick stems from stimulus checks sent to individuals and small business loans issued under the Paycheck Protection Program. IRS Criminal Investigation Chief Don Fort said last week “Even if that percentage of fraud is 1 percent, the numbers are still staggering in terms of what we’re up against.”

Reuters reported a glitch in the SBA’s loan processing system that may have caused as many as 1,200 loans to be issued more than once because the system did not account for borrowers submitting applications with multiple lenders. Reuters also reported that some PPP loans went to companies that paid no U.S. corporate tax in the last year. While PPP eligibility is not tied to the payment of taxes, CARES Act watchdogs may raise issues that taxpayer-funded support may have gone to companies that have paid no taxes themselves.
 
Inspectors General
Much of the oversight community has been focused on recent firings of Inspectors General in various agencies. Responding to several senators’ request that he do so, Scott Dahl, the IG of the Department of Labor, confirmed he is looking into the enforcement activities of and guidance issued by OSHA concerning the coronavirus. In announcing the audit last week before the House Committee on Oversight and Reform Subcommittee on Government Operations, Dahl noted that he was “very surprised” that OSHA had issued only one COVID-19-related citation, even though it received thousands of complaints.

Also this week, the Government Accountability Office (GAO) released a report titled “Inspectors General: Independence Principles and Considerations for Reform,” which was sent to Democratic and Republican members of Senate and House investigative committees. The report urges “Congress to use its constitutional oversight authorities to protect [Inspector General (IG)] independence.” It discusses key independence principles that it says that Offices of Inspectors General should follow; sets forth a framework for applying these principles to ongoing IG reform efforts; and provides reform options for Congress to consider.

House Committee on Oversight and Reform Chair Carolyn Maloney (D-NY), Subcommittee on Government Operations Chairman Gerald Connolly (D-VA) and Subcommittee on National Security Chairman Stephen Lynch (D-MA) issued a statement on the report, noting that it warns against the dangers of “dual-hat” IG appointees, whereby political appointees “already serving in senior positions under the Department heads they are supposed to oversee” are named as acting IGs. The lawmakers believe recent appointees Stephen Akard and Howard Elliott “should cease serving as acting IGs at the Departments of State and Transportation immediately.”
 
Congress
Hearings/Floor Activity
House is in pro forma session this week, with no votes scheduled. Leader Hoyer announced yesterday that the House will be back in session to vote on the Justice in Policing Act on June 25 and 26. Earlier this week a bicameral group of legislators released the bill in response to the nationwide Black Lives Matter protests following the murders of George Floyd, Breonna Taylor, and Ahmaud Arbery. The Senate is in session this week.
 
Appropriations
SAC plans to markup bills June 15-19, though it may slip to July. The subcommittee markup schedule has been reported as E&W, THUD, and Leg Branch on June 25; Interior, CJS, Ag, DHS on July 2; and the remaining bills to be determined. SAC is unlikely to markup the Homeland Security and MilCon/VA bills. SAC-D will likely not markup prior to August recess and may have to post a Chairman’s mark. 
 
Subcommittees will poll their member rather than meet in person and save the in-person markups for full committee, to minimize the number of times that committee members have to gather.
 
House Appropriations Committee Chairwoman Nita Lowey has sent out a Dear Colleague outlining that she plans to hold subcommittee and full committee markups the weeks of July 6 band 13. From there, the Committee is aiming to push all the bills to the House floor during the last two weeks of July, likely in two minibuses. Majority Leader Hoyer has said he wants to pass all the appropriations bills before the August recess.
 
House, Senate, and the White House have settled on an agreement for Veterans Affairs funding to exempt the Veteran’s Choice health care program from the budget caps and categorize it as emergency spending. This would save $11-$12 billion on the discretionary side and increase the odds of producing bipartisan bills.
 
NDAA
Yesterday the Senate Armed Services Committee approved the Senate’s FY21 National Defense Authorization Act. SASC plans to file the bill on June 15 to set up floor time the week of June 22. HASC Chairman Adam Smith and Ranking Member Thornberry announced that HASC will be marking up the bill the week of June 22, with the full markup on June 24.
 
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (0):
Currently Self-Quarantined (0):
Recovered (7): Sen. Rand Paul (R-KY), Rep. Joe Cunningham (D-SC), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL), Rep. Mike Kelly (R-PA), Rep. Nydia Velazquez (D-NY), Rep. Neal Dunn (R-FL)
Completed Quarantine (38): Sen. Ted Cruz (R-TX), Rep. Mark Meadows (R-NC), Sen. Lindsay Graham (R-SC), Rep. Don Beyer (D-VA), Rep. Sharice Davids (D-KS), Rep. Doug Collins (R-GA), Rep. Paul Gosar (R-AZ), Sen. Cory Gardner (R-CO), Sen. Rick Scott (R-FL), Rep. Matt Gaetz (R-FL), Rep. Jason Crow (D-CO), Rep. Julia Brownley (D-CA), Rep. Ben Ray Luján (D-NM), Rep. Gwen Moore (D-WI), Rep. Stephanie Murphy (D-FL), Rep. John Yarmuth (D-KY), Rep. Adam Schiff (D-CA), Rep. Vincente Gonzalez (D-TX), Rep. Drew Ferguson (R-GA), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Ann Wagner (R-MO), Rep. Kathleen Rice (D-NY), Rep. Matt Cartwright (D-PA), Rep. Tom Cole (R-OK), Rep. Steve Scalise (R-LA), Rep. Frederica Wilson (D-FL), Rep. Andy Kim (D-NJ), Rep. Kendra Horn (D-OK), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT), Rep. Katie Porter (D-CA), Rep. Seth Moulton (D-MA), Rep. Lizzie Fletcher (D-TX), Rep. Josh Gottheimer (D-NJ), Rep. Ayanna Pressley (D-MA), Rep. Mikie Sherrill (D-NJ), Sen. Lamar Alexander (R-TN)
 
Other Federal Actions
  • The FDA issued an EUA to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology. The FDA authorized the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. Using next generation sequencing means that the test can generate information about the genomic sequence of the virus present in a sample, which can be also used for research purposes.
  • FDA Commissioner Stephen Hahn said today that the CDC and the White House task force will be issuing guidance that “will have a lot of specificity” around how to use coronavirus tests.
  • The FDA and the NIH have made updates to the CURE ID crowd-sourcing app to make it easier for healthcare providers to share their experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial. CURE ID’s web-based repository lets providers share experiences with novel uses of existing drugs in treating difficult-to-treat infectious diseases. Healthcare providers worldwide are encouraged to share their COVID-19 treatment experiences via CURE ID.
  • An NIH study will evaluate drugs prescribed to treat COVID-19 in infants, children, and adolescents across the country. The study leverages an existing clinical trial that examines drugs that are prescribed off-label to children for a variety of medical conditions. Because many drugs have not been tested specifically for use in children, physicians will often prescribe drugs off-label to children because they lack an alternative, approved treatment.
  • The CDC continues to update its dashboard with new guidance and details. Today, the agency posted updated guidance for using telehealth to expand access to essential health services during the COVID-19 pandemic, additional information about the financial resources offered by the government during the pandemic, and new data visualizations for COVID-19 cases and deaths. 
  • Education Sec. Betsy DeVos hosted the second in a series of forums with K-12 education leaders this week to discuss best practices for remote learning, including lessons learned during the COVID-19 pandemic. More than 2,000 education leaders from across the country listened in as educators from Arizona, Connecticut, Indiana, Louisiana, Mississippi, and North Carolina discussed how they established innovative virtual learning capabilities to serve students and teachers now and in the future. A readout is available here
  • OSHA has published a series of frequently asked questions and answers regarding the use of masks in the workplace. The new guidance outlines the differences between cloth face coverings, surgical masks, and respirators. It further reminds employers not to use surgical masks or cloth face coverings when respirators are needed. In addition, the guidance notes the need for social distancing measures, even when workers are wearing cloth face coverings, and recommends following the CDC's guidance on washing face coverings.
  • Tomorrow, the new Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James Clyburn (D-SC), will hold a video briefing with experts and affected Americans to examine the impact of the COVID-19 pandemic on nursing home residents and workers.
  • There are multiple COVID-19 hearings slated to place in Congress this week:
    • Thursday (6/11) 1 PM House Administration: The Impact of COVID-19 on Voting Rights and Election Administration: Ensuring Safe and Fair Elections.
    • Thursday (6/11) 1 PM House Appropriations: Indian Health Service COVID-19 Response.
    • Thursday (6/11) 2 PM House VA: Assessing VA's Response to the COVID-19 Pandemic: 90 Days Later.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 1,973,797 total cases and 112,133 deaths The CDC data closes out the day before reporting. It is now being reported that there are more than 2 million cases in the U.S. 
  • Numbers of newly reported cases are still rising in 21 states. Arizona and Texas, in particular, have emerged as hot spots over the last few weeks. 
  • Iowa announced today that the Iowa State Fair will not be held this year. 
  • New Jersey Gov. Phil Murphy (D) signed an EO to reopen outdoor swimming pools on June 22nd. Additionally, outdoor recreational and entertainment businesses are permitted to reopen immediately, with the exception of amusement parks, water parks, and arcades. These recreational and entertainment businesses are required to abide by a number of social distancing protocols that are specified in the order. Public and private social clubs are permitted to reopen their outdoor spaces, provided they comply with all applicable terms of the order.
  • Pennsylvania Gov. Tom Wolf (D) issued preliminary guidance for high school and recreational sports teams to resume voluntary workouts and other in-person activities in the state’s yellow and green phases. The guidance includes college and professional sports.
  • Washington Gov. Jay Inslee (D) issued new guidance for domestic services in phase two. Gov. Inslee also issued expanded and updated guidance for certain recreational activities.
  • Nevada Gov. Steve Sisolak (D) signed a directive allowing local school districts, charter schools, and private schools to immediately reopen for summer learning and activities while implementing the phase two protocols designed to keep students, staff, families, and communities safe.
  • Gov. Ralph Northam (D) announced a phased approach that allows Virginia schools to slowly resume in-person classes for summer school and the coming academic year. The K-12 phased reopening plan was developed by the Office of the Secretary of Education, Virginia Department of Health, and the Virginia Department of Education and is informed by guidelines from the CDC.
  • Gov. Gretchen Whitmer (D) signed an EO which continues expanded access and capacity for child care services, giving priority to essential workers. The order takes effect immediately and continues through July 7th.
  • Mississippi Gov. Tate Reeves (R) extended his Safe Return order an additional two weeks to June 29th. The order also amends the Safe Return order by removing the curfew on restaurants and bars that serve alcohol, allowing fitness centers/gyms to increase capacity to 50 percent, increasing reception hall capacity to 50 percent, and allows the opening of outdoor and indoor arenas up to 25 percent capacity. The order instructs all state and local government agencies to resume normal business operations no later than July 1st.
  • Maryland Gov. Larry Hogan (R) said restaurants can reopen at 50 percent capacity starting Friday, and gyms, malls, and casinos will be allowed to open in some capacity next Friday, June 19th. 
  • Useful state data:
    • The NYT is tracking which states are reopening and which are still shut down.
    • These charts show cumulative coronavirus cases and deaths for metropolitan areas over time.
    • Use Johns Hopkins University’s COVID-19 U.S. map as a resource for media, policymakers, and communities to view a collection of critical public health data in one online destination and better understand and track the COVID-19 pandemic in populations both large and small across the country.
    • NASHP has developed a COVID-19 State Action Center which serves as a state-level policy dashboard. Governing is also keeping a running tally of coronavirus news and impacts at the intersection of the health and economic crises in the states and localities.
    • This site from the Kaiser Family Foundation provides state-level information on cases/deaths, social distancing measures, health policy actions, and more.
    • This resource from Bloomberg Law is a database of State Quarantine and Public Health Laws related to the COVID-19 response.
    • This series of maps shows how states are responding to COVID-19, and this tracker, created and maintained by MultiState Associates, has an up-to-date list of executive orders and various travel restrictions.
    • Finally, this site offers COVID-19 projections assuming full social distancing and can be broken down by state.
International Affairs
  • Germany will lift its border controls with neighbors France, Austria, Switzerland, and Denmark on June 15th. New arrivals from Italy will also no longer have to go through border controls, though the two countries do not share a physical border. The controls will be relaxed for travelers arriving from Spain by plane starting on June 21st. The easing of restrictions comes as the country slowly rolls back its strictest lockdown measures.
  • Japanese tech conglomerate SoftBank just conducted voluntary COVID-19 antibody tests on more than 44,000 employees, their families, clients, and outside medical professionals such as doctors and dentists. 
  • Poland has shut down 12 coal mines after the country’s health minister said most of its COVID-19 cases had been identified at these “hotspots.” At least two coal mines have more than 1,000 confirmed cases, according to figures supplied by coal companies.
  • The E.U. harshly criticized China’s role in the spread of false information about the pandemic, saying today that the country had engaged in “targeted influence operations and disinformation campaigns in the bloc.” In a new report, the European Commission, the executive branch of the E.U., blamed “foreign actors and certain third countries, in particular Russia and China,” for the disinformation campaigns. 
  • India is now reporting more new daily infections than all other countries except the U.S. and Brazil. New Delhi and Mumbai, the two biggest cities, are simply overloaded with infections. Experts have said the peak is several weeks away. Government officials are beginning to propose turning some of New Delhi’s fanciest hotels into hospitals.
  • Following Iran's decision to lift restrictions last month, they are now experiencing a surge in cases. 
  • Global Cases:  7,400,013       Total Deaths:  417,133
Lifestyle, Science, and Economy
  • Officials at the Federal Reserve indicated that they expect the unemployment rate to end 2020 at 9.3 percent and remain elevated for years.
  • The Treasury Department said today that the U.S. budget deficit grew to a record $1.88 trillion for the first eight months of this fiscal year, as Congress passed economic relief packages and the government delayed tax payments.
  • The Organization for Economic Cooperation and Development (OECD) indicated in a new report that the world economy is facing the most severe recession in a century and could have an exceptionally difficult time recovering due to a potential second wave of COVID-19. 
  • Los Angeles County issued guidelines for film and television to begin production as early as Friday, but it’s more likely that production will not resume until July at the earliest. Studios and production companies are still waiting for unions to determine job protocols, even though the industry issued its own white paper last week that established general guidelines for resuming production.
  • Disney announced a phased reopening plan for the Disneyland Resort in California that includes limited capacity and a new theme-park reservation system. The plan begins with reopening the Downtown Disney District, home to the flagship World of Disney store, on July 9th, according to a company statement. Both Disneyland Park and Disney California Adventure would follow on July 17th, then Disney’s Grand Californian Hotel & Spa and Disney’s Paradise Pier Hotel on July 23rd, pending approval from local and state governments.
  • Indonesian officials are worried about a possible post-pandemic baby boom. During lock down in April, about 10 million married couples stopped using contraception, according to the National Population and Family Planning Agency.
  • The WHO keeps a running list of COVID-19 vaccine candidates, which you can view here. They are now reporting 133 potential vaccines, 10 of which are in clinical trials in the U.S., U.K., and China. STAT News also has a resource tracking COVID-19 drugs and vaccines
  • Continue to look at the NIH Office of Portfolio Analysis’s (OPA) expert-curated portfolio of COVID-19 publications and preprints. The portfolio includes peer-reviewed articles from PubMed and preprints from medRxiv, bioRxiv, ChemRxiv, and arXiv. It is updated daily with the latest available data and enables users to explore and analyze the rapidly growing set of advances in COVID-19 research.
  • Forbes is keeping a running list of all major international airline COVID-19-related change and cancellation policies.
  • RetailDive tracks store reopenings in the U.S. 
Helpful Articles/Media
Please contact me directly with any questions and I would be happy to assist.

Sincerely,
Jessica

Jessica Hyland, J.D.
Executive Director
Iowa Biotechnology Association
Cell: (515) 822-1315
Office: (515) 327-9156
Fax: (515) 327-1407
jessica@iowabio.org
www.iowabio.org
Copyright © 2020 Iowa Biotechnology Association, All rights reserved.


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