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COVID-19 Update
March 23, 2020

IowaBio wants to provide our members useful information during the COVID-19 public health emergency. 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.

Iowa Update
Gov. Reynolds will hold a press conference today at 2:30 p.m. The press conference will be streamed and posted in full on Governor Reynolds’ Facebook Page, and on YouTube.

Governor Kim Reynolds held a press conference Sunday afternoon.  At this time, she is not ordering a “shelter in place” declaration but is stressing for Iowans to social distance and stay home if they are not feeling well. IowaBio sent a letter to the Governor’s office last week, asking for an exemption for biotech and pharmaceutical companies and their supply chain, should the Governor declare a shelter-in-place order.
 
Governor Reynolds urged that Iowans who have traveled recently for business or spring break vacations, whether internationally or domestically outside of Iowa, should strongly consider self-isolating for 14 days. This will support Iowa's ongoing efforts to mitigate the spread of COVID-19, and limit the introduction of the virus from other points of travel.
 
The Governor signed an additional executive order, which took effect at 10 p.m. Sunday, stating Iowa’s salons, barber shops, medical spas, massage therapists, tattoo shops and swimming pools will be closed until March 31 The Governor has also suspended foreclosures on residential, commercial and agriculture properties. 
 
This morning, the Iowa Department of Public Health (IDPH) has been notified of 15 additional positive cases of Iowans with COVID-19, for a total of 105 positive cases. There have been a total of 2,043 negative tests to date, which includes testing reported by the State Hygienic Lab and other labs. 
 
According to IDPH, the locations and age ranges of the 15 individuals include:
  • Allamakee County, 1 adult (18-40 years)
  • Dubuque County, 1 adult (18-40 years), 1 older adult (61-80 years)
  • Hancock County, 2 older adults (61-80 years)
  • Johnson County, 1 middle-aged adult (41-60 years), 2 older adults (61-80 years)
  • Linn County, 1 adult (18-40 years), 1 middle-aged adult (41-60 years)
  • Muscatine County, 1 middle-aged adult (41-60 years)
  • Polk County, 1 adult (18-40 years), 1 middle-aged adult (41-60 years)
  • Wapello County, 1 older adult (61-80 years)
  • Woodbury County, 1 middle-aged adult (41-60 years)
A status report of monitoring and testing of COVID19 in Iowa is provided by IDPH and can be found here. In addition, a public hotline has been established for Iowans with questions about COVID-19. The line is available 24/7 by calling 2-1-1 or 1-800-244-7431. The state of Iowa has started sharing the number of negative tests conducted at other labs, and will soon provide additional information regarding hospitalization and recovery. 
 
The legislature convened and worked late into the night March 16 to respond to COVID-19 in Iowa. The Legislature passed a deal that funds the government through the end of August and suspended the legislative session for at least 30 days through April 15. (SF2408 and SCR102) The capitol building is closed to the public until March 31. It is unclear at this time when the session will reconvene.
 
Economic/Business
The U.S. Small Business Administration (SBA) is now making loans available statewide to small businesses and private, non-profit organizations to help alleviate economic injury caused by the Coronavirus (COVID-19). SBA’s Economic Injury Disaster Loans offer up to $2 million in assistance and can provide vital economic support to small businesses to help overcome the temporary loss of revenue they are experiencing.
 
These loans may be used to pay fixed debts, payroll, accounts payable and other bills that can’t be paid because of the disaster’s impact.
  • The interest rate is 3.75% for small businesses.
  • The interest rate for non-profits is 2.75%.
  • SBA offers loans with long-term repayments in order to keep payments affordable, up to a maximum of 30 years.
 
Industry Response Update
IowaBio member companies are stepping up to respond to COVID-19. IowaBio member companies including Integrated DNA Technologies, Pfizer, and Johnson & Johnson among others, are helping respond directly to the threat of the virus, developing tests, and vaccines respectively and ramping up production capacity. 

This article has a great compilation of the pharmaceutical industry’s response to the virus and companies’ efforts to develop drugs and vaccines to combat it.

If your company is responding to COVID-19 IowaBio wants to know about it! Please, share your information with jessica@iowabio.org
 
Washington, D.C.
  • Congress is still determined to pass a third supplemental funding package, “COVID-III.” Negotiations continued through the weekend. There has not yet been a bipartisan solution, but the Senate is working feverishly to get legislation passed as soon as possible.
  • Last week, U.S. trade officials removed tariffs on dozens of medical items imported from China amid the COVID-19 outbreak including some protective gowns, exam gloves, patient bags, surgical drapes, and medical waste disposal bags. Tariffs still remain on many medical items, such as high-tech equipment and components to systems like ultrasound machines, patient monitors, X-ray devices, defibrillators, and electro cardiograms. This weekend, the Office of the United States Trade Representative (USTR) opened a docket for members of the public, businesses, and government agencies to submit comments if they believe further modifications to the 301 tariffs may be necessary. 
  • CMS announced it is granting exceptions from reporting requirements and extensions for clinicians and providers participating in Medicare quality reporting programs with respect to upcoming measure reporting and data submission for those programs. 
  • CMS introduced a series of new COVID-19 checklists and tools to accelerate relief for state Medicaid and CHIP programs.
  • FDA issued new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during the pandemic.
  • FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.
  • Lastly, the FDA published an enforcement policy for ventilators and accessories and other respiratory devices. FDA issued the guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during the pandemic.
  • Sen. Rand Paul (R-KY) joined Reps. Mario Diaz-Balart (R-FL) and Ben McAdams (D-UT) as the only members of Congress who have tested positive for COVID-19; however, 26 other members are now in self-quarantine.
Federal Legislation
Supplemental III – “COVID-III”
Timeline: McConnell moved the cloture vote to 6pm to allow for extended time for negotiations. The 6pm procedural vote failed 47-47 (the motion needed 60 votes to pass). After the vote, Leader Schumer outlined the problems Democrats had with the current form of the bill, noting that the two sides “can and should” overcome their disagreements in the next 24 hours.

Process and Politics: Negotiations continued through the weekend, but not enough progress was made to gain Democratic support by voting time. Democrats have indicated that their top concerns are 1) support for corporations with little oversight or protections for workers, 2) lack of funding for hospitals, medical workers, states, and cities, and 3) expansions to unemployment insurance are not available long enough. Both sides are hopeful to move a bill through the Senate tomorrow and negotiations continue to be ongoing. Also, another bill might be thrown in the mix as Speaker Pelosi has said that the House will release its own bill and it will “hopefully be compatible” with the Senate’s.

Policy: As with previous big deals, nothing is final until everything is final. All policies previously discussed continue to be on the table and could be part of a final deal. Republicans released an updated text of CARES which reflects significant bipartisan and administration input, though it is not the finalized text. Democrats have expressed significant reservations with the text and negotiations continue. Summary of Title I (Small Business), II (Individual and Business provisions), IV (Economic Stabilization) here. Summary of Title III (Health) here. Summary of Division B (appropriations) here. Highlights of changes include:
  • $349 (up from $300) billion for the Small Business Administration’s 7(a) program, and nearly $300 billion for loan guarantees and loan subsidies; 
  • The removal of phase-in or other limitations for low-income taxpayers to receive cash grant;
  • The treatment of cash grants to individuals as a fully refundable tax credit (and thus, available to taxpayers with net negative income tax liability);
  • Removes the delay of tax filing for individuals (as it is believed that administrative action alone is sufficient);
  • Removal of two of the three TCJA technical correction, but kept QIP;
  • $500 billion (increased from $208 billion) in Treasury-administered loans for economic stabilization, including:
    • $17 (up from $0) billion to “businesses critical to maintaining national security;”
    • $425 (up from $150) billion for all other businesses;
  • 3-month expansion to unemployment insurance eligibility for reasons related to COVID-19 (either directly or due to business closures related to COVID-19);
  • $242 billion in appropriations (summary here), which designates the following:
    • $100 billion for health preparedness like vaccines, therapeutics, diagnostics;
    • $75 billion for hospitals;
    • $20 billion for veterans’ health;
    • $20 billion for public transportation relief;
    • $12 billion for DOD;
    • $12 billion for K-12 education and $6 billion for higher-ed;
    • $10 billion for state block grants;
    • $10 billion for airports; and
    • $5 billion for FEMA disaster relief;
    • $4.5 billion for CDC; and
    • $1.7 billion for the Strategic National Stockpile (SNS).
Supplemental IV and onward
  • Leadership has agreed on drafting a fourth and fifth supplemental – unclear what will be included yet.
Passed Legislation
Supplemental II – Families First Coronavirus Response Act (HR 6201)
  • The Senate passed the bill 90-8 Wednesday afternoon and the President signed the bill into law that evening. Bill text here. Factsheet here. Bill section by section here. A summary of paid leave provisions, incorporating changes made by technical correction, is here.
Supplemental I – Coronavirus Supplemental
  • Signed by the President March 6.
  • Text here, summary here.
Congress
  • House is currently in recess but will be called back when votes are needed on the next supplemental (with 24-hour notice). House Democratic leaders have said that members will not have to return until after a deal the supplemental is reached.
  • Senate is in session. Leader McConnell has said the Senate will stay in session until a third supplemental has passed.
  • As of right now, the appropriations markup schedule is unchanged. Most House bills have subcommittee markup dates the weeks of April 21 and April 28, while the Senate has not yet set its markup dates.
  • Remote voting: Speaker Pelosi and Leader McConnell have both voiced opposition to members’ voting remotely, but as more members of Congress have begun self-quarantining and the pandemic makes travel more treacherous, in-person voting may become more difficult. Speaker Pelosi circulated a Dear Colleague last week stating that the House will “adjust our voting procedures in order to follow the CDC’s recommendations.” Similarly, in its notice of the vote Sunday, the Senate Cloakroom encouraged members to socially distance during votes. Remote voting is being discussed to some extent in both chambers.
  • Virtual hearings: While most hearings and markups for the next week or so have been canceled, some committee staff are working to see whether holding hearings virtually is possible.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (3): Sen. Rand Paul (R-KY), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL)

Currently Self-Quarantined (26): Rep. Paul Gosar (R-AZ), Rep. Julia Brownley (D-CA), Rep. Jason Crow (D-CO), Rep. Matt Gaetz (R-FL), Rep. Mario Diaz-Balart (R-FL), Rep. Doug Collins (R-GA), Rep. Steve Scalise (R-LA), Rep. Ann Wagner (R-MO), Rep. Ben Ray Luján (D-NM), Rep. Kathleen Rice (D-NY), Rep. Kendra Horn (D-OK), Rep. Matt Cartwright (D-PA), Rep. Ben McAdams (D-UT), Rep. Gwen Moore (D-WI), Rep. Frederica Wilson (D-FL), Rep. Stephanie Murphy (D-FL), Rep. Drew Ferguson (R-GA), Rep. Joe Cunningham (D-SC), Rep. Tom Cole (R-OK), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Andy Kim (D-NJ), Sen. Rick Scott (R-FL), Sen. Cory Gardner (R-CO), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT)

Completed Quarantine (2): Sen. Ted Cruz (R-TX), Rep. Mark Meadows (R-NC), Sen. Lindsay Graham (R-SC)

Updates from the States
  • Per the CDC Website: Data include both confirmed and presumptive positive cases of COVID-19 reported to CDC or tested at CDC since January 21, 2020, with the exception of testing results for persons repatriated to the United States from Wuhan, China and Japan. State and local public health departments are now testing and publicly reporting their cases. In the event of a discrepancy between CDC cases and cases reported by state and local public health officials, data reported by states should be considered the most up to date. The CDC is no longer reporting the number of persons under investigation (PUIs), PUIs that have tested negative, or cases of people repatriated. Additionally, these numbers do not include testing being done at state and local public health laboratories.
    • Out of the cases under investigation detected by U.S. surveillance, there are total cases: 15,219  travel-related: 337  “close contact”: 321 The CDC now updates data Monday through Friday and data closes out the day before reporting, so this data is only recent as of Friday. Tomorrow’s report will be more up-to-date.
    • The CDC is still reporting 201 deaths in the U.S. related to COVID-19. This number is likely to spike significantly tomorrow when they incorporate this weekend’s data.
    • New York has now reported 15,168 confirmed cases of COVID-19, which means it accounts for approximately five percent of all cases in the world.
  • Forty-six states have now closed schools. This site maps school closures and is updated twice daily on weekdays and once daily on weekends.
  • California Gov. Gavin Newsom and multiple other governors today requested a Presidential Major Disaster Declaration to assist in California’s COVID-19 preparedness and emergency response efforts. The Major Disaster Declaration would include any and all individual assistance programs to assist those affected by the outbreak and lessen the economic impacts of the crisis. The request would provide additional assistance, including but not limited to, mass care and emergency assistance, crisis counseling, disaster case management, disaster unemployment assistance, disaster legal services, and Disaster Supplemental Nutrition Assistance.
    • In response, President Trump said this evening that major disaster declarations were in process for New York, California, and Washington, and that they would not have to pay for deploying National Guard units. He also said he has directed FEMA to supply federal medical stations with thousands of beds in all three states.
  • Louisiana Gov. John Bel Edwards issued a statewide stay at home order effective 5pm tomorrow until April 13th with the possibility of extension.
  • Many other governors have signed similar orders this week. This document provides a more comprehensive list of state declarations and orders of essential businesses.
 International Affairs
  • Chancellor Angela Merkel of German is entering isolation after her doctor tested positive for COVID-19. Earlier in the weekend, Germany banned group gatherings of more than two people (with the exception of families). The rule will be in effect for at least two weeks.
  • According to the Spanish health ministry, 3,500 doctors and other health workers have tested positive for COVID-19 in the country, making up about 12 percent of the country’s cases.
  • Italy reported an additional 3,957 cases and 651 deaths today. Their totals are now 59,138 and 5,476, respectively.  
  • Prime Minister Kyriakos Mitsotakis of Greece has banned all unnecessary movement by citizens across the country. Starting tomorrow morning, only individuals who are going to or from work, buying food, visiting a doctor or pharmacy, exercising, or walking a pet will be allowed on the streets.
  • In Iran, where there are more than 21,000 cases, supreme leader Ayatollah Ali Khamenei reportedly rejected an offer of U.S. assistance, referencing a conspiracy theory that the U.S. created the virus.
  • Global Cases:  292,142    Total Deaths:  12,784
 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 Biotech Association, All rights reserved.


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