Duckworth, Durbin Press CDC on Shortage of Coronavirus Test Kit Supplies
[WASHINGTON, D.C.]—Amid the coronavirus (COVID-19) outbreak, U.S. Senators Dick Durbin (D-IL) and Tammy Duckworth (D-IL) today pressed the Centers for Disease Control and Prevention (CDC) Director Robert Redfield for information on the potential shortage of enzymes needed for CDC coronavirus test kits. Health officials in Illinois have indicated they may not have enough testing supplies to cover their diagnostic needs over the next two weeks. Further, they have not received word from the CDC about when they will receive their next shipment of test kit supplies.
“To address this urgent public health concern, we urge you, working with other federal agencies, industry stakeholders, and state and local partners, to take expeditious action to address this supply chain issue and improve communication to our state health officials, who are on the front lines of containing this COVID-19 outbreak. It is imperative that there be no gap in our public health departments’ ability to test and diagnose COVID-19,” the Senators wrote in a letter to Director Redfield.
Yesterday, Durbin spoke with officials at CDC about the urgent need for additional coronavirus test kit supplies in Illinois and around the country in order to improve diagnosis and treatment efforts.
There have now been three major problems with the U.S. coronavirus test kit supply: (1) initial shortages of the actual test kits; (2) problem with one of the reagents that caused inconclusive test results; and now (3) global shortage of an enzyme used in the reagent.
Full text of the letter can be found here and below:
March 12, 2020
Dear Director Redfield:
We write with concerns about the testing availability in the United States for COVID-19, particularly due to a potential shortage of enzymes needed for the Centers for Disease Control and Prevention (CDC) test kits. There are now more than 1,000 cases of COVID-19 cases in the United States and 30 deaths. Illinois has confirmed 25 cases—more than quadruple the count since the weekend—and the Governor has declared a state of emergency. Health officials in Illinois have indicated they may not have enough testing supplies to cover their diagnostic needs over the next two weeks. Further, they have not received word from the CDC about when they will receive their next shipment of test kit supplies. With the dramatic rise in cases—that does not seem to be abating—we urge the CDC, in collaboration with the Food and Drug Administration, commercial producers, and state and local partners, to take immediate action to ensure state and local governments have the test kit supplies needed to diagnose COVID-19, ensuring no delay in testing capabilities.
You told POLITICO on March 10, that you are not confident that U.S. labs have an adequate stock of enzyme supplies used in the reagent that is integral for determining whether or not someone has COVID-19. We recognize that CDC announced interim guidance on March 10, permitting states to consolidate test samples in order to preserve adequate supply of laboratory materials. However, based upon urgent reports from health officials in Illinois, we are highly concerned about the supply of reagent used in the COVID-19 test kits—particularly if there is a limited manufacturing source.
We are worried that there have now been a few missteps in this Administration’s handling of the COVID-19 test kits. First, we saw nationwide shortages of the test kits. By the end of February, the World Health Organization (WHO) had shipped COVID-19 tests to nearly 60 countries. The United States declined the WHO test and the CDC produced its own test here in the United States, but apparently not enough. Then, the United States identified a problem with the reagent being used in our test kits—leading to delayed diagnosis and inconclusive results. And now, we have this enzyme shortage that is threatening to significantly delay our states’ ability to test and confirm whether American patients have COVID-19. While other countries are currently testing in the tens of thousands of patients (for example, South Korea has reportedly tested at least 65,000 people), the United States has reportedly only tested about 5,000 people. Department of Health and Human Services (HHS) Secretary Azar even acknowledged this past Monday that he did not know how many people have been tested for COVID-19 in the United States.
Earlier this week, Illinois public health officials told us they are anticipating exhaustion of their supplies to test patients for COVID-19 in the very near future. They have also reported that CDC has provided no information on when they can expect the next shipment of test kit materials, or whether CDC has the capacity to meet the current need. We are sure many other states are running into this same issue.
To address this urgent public health concern, we urge you, working with other federal agencies, industry stakeholders, and state and local partners, to take expeditious action to address this supply chain issue and improve communication to our state health officials, who are on the front lines of containing this COVID-19 outbreak. It is imperative that there be no gap in our public health departments’ ability to test and diagnose COVID-19.
Thank you for your attention to this matter. Please let us know if there is anything you need from Congress to protect Americans from this public health challenge. We look forward to working with you.
Sincerely,
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