Letter to Dr. Stephen Hahn, Commissioner of the Food and Drug Administration - Too Much at Stake for Delay or Profiteering: Schakowsky, Doggett, DeLauro Press Administration on Coronavirus Test Kit Deployment, Pricing

Letter

Dear Commissioner Hahn:

On Monday, March 2, 2020, you predicted that "close to a million" coronavirus test kits would be in place by the end of the week. This plan was reiterated at yesterday's bipartisan Congressional briefing. Yet later yesterday, Vice President Pence acknowledged that this Administration promise will not be kept. He should know, since last weekend he said more than 15,000 test kits with materials to test 700-800 samples were being shipped to labs, though only 47 such kits were actually shipped.

With the Administration's failure to be prepared with adequate testing capability having already contributed to community spread and the number of coronavirus cases and deaths growing, we are greatly concerned about the delayed Administration response. Please answer the following questions:

By how much has the Administration failed to meet the goal you set?
How many kits have actually been shipped?
By what realistic date will the "close to a million" commitment actually be achieved?
What was the cause or causes of the Administration failing to keep this commitment?
Given an indication by the Association of Public Health Laboratories that only about 10,000 tests per day could be conducted when all of it labs across America are fully operational, what is the estimated time for evaluating and reporting back on whether a test sample is positive?
When do you estimate that point-of-care testing will be available so that Americans can get prompt test results to determine their condition?
Which companies have COVID-19 test kits approved by the FDA, and which have pending requests for approval? Please provide the estimated dates of when that approval may be granted and when kits will be deployed.

We look forward to your prompt reply.

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