March 18, 2020

Hirono, 16 Senate Colleagues: Trump Administration Must Answer for Delays, Shortage in COVID-19 Testing Kits

WASHINGTON, D.C. – Senator Mazie K. Hirono (D-Hawaii) and 16 of her Senate colleagues wrote to Vice President Pence and Assistant Secretary of Health Brett Giroir, the Trump Administration’s new COVID-19 head of diagnostic efforts, demanding an explanation of the Administration’s unmitigated failure to produce sufficient test kits, which has hampered the nation’s ability to effectively detect COVID-19 and take necessary actions to slow the spread of the virus.

The Senators cite the weeks in delay for testing, initial narrow testing criteria, and emerging shortages of materials to conduct tests. The lack of testing has created heightened uncertainty for hospitals and health care providers attempting to curtail this pandemic.

The letter, led by Senator Elizabeth Warren (D-Mass.), asks Vice President Pence and Assistant Secretary Giroir to detail America’s testing capabilities, the Trump Administration’s failure to provide clear facts about COVID-19, and the potential manufacturing shortages labs may encounter. 

“The ability to accurately and swiftly test for COVID-19 is critical to informing public health decisions—like social distancing, quarantining, and contact tracing—which can slow the exponential growth of the virus,” the Senators wrote.

The Senators continued, “The Administration’s continued failure to ensure a sufficient number of diagnostic testing kits for COVID-19 are available, and its inability to provide clear and honest answers about this problem in the midst of this public health emergency, is unacceptable, and the American public deserves answers.”

Senator Warren led the letter, which Senator Hirono and Senators Tammy Baldwin (D-Wis.), Richard Blumenthal (D-Conn.), Cory A. Booker (D-N.J.), Sherrod Brown (D-Ohio), Robert P. Casey, Jr. (D-Pa.), Martin Heinrich (D-N.M.), Chris Van Hollen (D-Md.), Tim Kaine (D-Va.), Amy Klobuchar (D-Minn.), Edward J. Markey (D-Mass.), Patty Murray (D-Wash.), Bernard Sanders (I-Vt.), Tina Smith (D-Minn.), Debbie Stabenow (D-Mich.), and Ron Wyden (D-Ore.) signed.

The text of the letter can be found here and below:

Dear Vice President Pence and Assistant Secretary Giroir:

We write to Vice President Pence in his capacity as head of the White House Coronavirus Task Force (Task Force) and to Assistant Secretary Giroir in his capacity as coordinator for diagnostic testing efforts to request information on the Trump Administration’s failure to ensure that diagnostic tests are available for coronavirus disease 2019 (COVID-19). This failure has resulted in a significant delay in detecting and responding to the first cases of COVID-19 in the United States, dramatically increasing the scope of the epidemic, and placing millions at risk. These problems—caused in part by the Administration’s lack of strong support for public health infrastructure prior to the COVID-19 outbreak and its mismanagement of test kit deployment as the crisis emerged—have been exacerbated by the numerous false statements by Vice President Pence, by other members of the Task Force, and by President Trump about the status of testing. 

In early January, Chinese scientists first posted the genome of the novel coronavirus causing COVID-19, and less than one week later, Berlin virologists had developed the first diagnostic test for the disease. Shortly thereafter, other countries began producing their own diagnostic tests, and by the end of February, the World Health Organization (WHO) had distributed COVID-19 tests to nearly 60 countries.

On February 5, 2020, the Centers for Disease Control and Prevention (CDC) began shipping hundreds of three-reagent diagnostic tests to state and local labs. However, by mid-February, states began reporting that the tests distributed by the CDC were delivering inconclusive results. According to the Association of Public Health Laboratories, only six state public health labs nationwide were able to verify the CDC test for use. The CDC cited manufacturing issues with one of the reagents, and promised to promptly re-manufacture the tests. 

After a multi-week delay, on February 26, 2020, the CDC announced it had fixed the issue with the test kits. Later, a scientist from the U.S. Food and Drug Administration (FDA) reported potential contamination at the CDC labs where tests were being made. It is not clear whether this contamination caused delays or is related to the manufacturing issues cited by the CDC. During this critical period, fewer than 500 patients were tested nationwide.

All the while, state, academic, and commercial labs could not use their own diagnostic tests without first obtaining FDA authorization. On February 29, 2020, the FDA finally announced an “accelerated policy…to achieve more rapid testing capacity in the United States,” which allowed qualified labs that develop their own validated tests to conduct testing for a period of up to 15 days prior to seeking FDA authorization.

Due to this unavailability of tests, the CDC was forced to issue extremely narrow testing criteria. Originally, the CDC only allowed people who had traveled to China or who had been in close contact with someone known to have COVID-19 to receive a test. As a result, at least one patient who later tested positive for COVID-19 was initially denied a diagnostic test. On March 3, 2020, the federal government broadened patient testing criteria that had limited early testing; Vice President Pence announced, “subject to doctors’ orders, any American can be tested.” This announcement, however, did not acknowledge the nation’s significant lack of testing capacity, leaving “many with questions about what had happened with testing and what should happen next.”

Since then, the Trump Administration has made a series of false promises about the country’s diagnostic capacities, spreading confusing and untrue information about the availability of tests for the general public. On March 6, 2020, President Trump falsely claimed, “[a]nybody right now and yesterday, anybody that needs a test gets a test,” and “[t]hey’re there. They have the tests and the tests are beautiful”—despite the fact that widespread tests were not available. Vice President Pence made similar promises about the availability of tests, and earlier this month U.S. Health and Human Services (HHS) Secretary Azar promised the availability of “as many as 4 million tests” by the middle of March. Though the CDC expanded testing criteria, states and local health authorities are still “clamoring” and “pleading” for additional tests.

And just as commercial and academic labs may be able to ramp up testing, they have run into even more barriers: a purported shortage in materials has threatened to hamstring testing capacity. According to CDC Director Robert Redfield, U.S. labs may not have an adequate supply of RNA extraction kits, a critical component that allows the tests to be performed. There have also been reports of potential shortages of cotton swabs, gloves, and other protective gear that is needed to perform test.

Now—almost two months since the United States announced its first confirmed coronavirus case—the United States has over 4,000 confirmed cases and at least 70 deaths, with thousands more under quarantine and surveillance. As demand for COVID-19 diagnostic tests overwhelms the limited supply, it is clear that COVID-19 has been spreading undetected and our understanding of the incidences of COVID-19 in the country is marred by a vast undercount.

The ability to accurately and swiftly test for COVID-19 is critical to informing public health decisions—like social distancing, quarantining, and contact tracing—which can slow the exponential growth of the virus. In the words of one virologist, “I think that we could have probably controlled this, if we had effective testing.” The Administration’s continued failure to ensure a sufficient number of diagnostic testing kits for COVID-19 are available, and its inability to provide clear and honest answers about this problem in the midst of this public health emergency, is unacceptable. The American public deserves answers. Please respond to the following questions by no later than March 30, 2020: 

1.     When did key Task Force officials – including Vice President Pence, Secretary Azar, and Director Redfield – become aware of delays in developing the CDC-approved tests?  What actions did these officials take to address these delays?

2.     What is the current COVID-19 testing capacity of the CDC and all (a) federal public health laboratories (b) state and local public health laboratories and (c) commercial and academic laboratories? 

a.     What is the limiting factor on the number of tests, and what actions are being taken by the FDA, the CDC, and the Task Force to address this limit?

b.     Which laboratories or companies, if any, is the Administration prioritizing in its effort to expand both public and private capacity to manufacture and deliver tests? Why is the Administration prioritizing these laboratories or companies? 

3.     What is the explanation for the misinformation provided to the public about the availability of COVID-19 tests by (1) President Trump (2) Secretary Azar, and (3) Vice President Pence?

4.     What guidance is the Task Force, the CDC, and the FDA currently providing to states that do not have enough testing capacity to meet the demand?

5.     Is the Task Force aware of any limitations on testing that could be caused by shortages in RNA test kits?

a.     Is there a shortage or anticipated shortage of any test components?

b.     What are these limits, and what is the cause of any shortage?

c.     What plans does the Task Force have to address any current or future shortage?

6.     Is the Task Force aware of any limitations on testing that could be caused by other supply shortages or for any other reasons?

a.     What are these limits, and what is the cause of the shortages?

b.     What plans does the Task Force have to address these shortages?

7.     What other actions are the Task Force, the CDC, and the FDA considering undertaking to help states and labs who are facing testing supply shortages?

###