Too Much at Stake for Delay or Profiteering: Schakowsky, Doggett, DeLauro Press Administration on Coronavirus Test Kit Deployment, Pricing

March 6, 2020
Press Release

Washington, D.C. – Today, Representative Jan Schakowsky (D-IL), a Senior Chief Deputy Whip and Chairwoman of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, U.S. Representative Lloyd Doggett (D-TX), Chairman of the House Ways and Means Health Subcommittee, and Representative Rosa DeLauro, Chairwoman of the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, submitted two inquiries to the Trump Administration regarding the affordability and readiness of coronavirus testing across the United States. As longtime advocates for patients against exploitative industry profiteering, they are working to ensure that the testing necessary to curb a looming American pandemic does not fall prey to such tactics.

HHS Secretary Azar is asked to ensure that privately-manufactured coronavirus test kits are being reasonably priced. FDA Commissioner Hahn is asked to swiftly increase testing capacity and respond on the failure to meet their “one million” tests commitment.

“Too often, public-private partnerships result in costly innovations that are inaccessible to many,” the lawmakers write. “Taxpayers finance the research for products sold at whatever the market will bear. In order to contain this COVID-19 epidemic, affordable testing must be available to quickly identify patients with the virus and mitigate community spread. We write to ensure that both the taxpayer investment and public health are protected in any purchases.”

In their second letter, the lawmakers emphasize, “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.” They question the Administration regarding the reason and details on the failure to meet the goal of one million tests, and to provide an estimate on when Americans can receive point-of-care testing.

Both letters are available here and here and copied below.

 

Dear Secretary Azar:

 

Since the emergency supplemental funding measure just approved by Congress includes funds for the purchase of testing kits and personal protective equipment, we seek your engagement regarding the pricing of these products. While widespread price gouging on personal protective equipment, such as N95 masks, has been reported, little information has been available about testing kits.

 

With FDA Commissioner Stephen Hahn indicating that “by the end of this week, close to a million tests will be able to be performed,” testing capacity will largely depend upon the private sector. Integrated DNA Technologies is working to produce and deploy testing kits and Quest Diagnostics has reported it is launching a testing kit. Other companies may follow.

 

Too often, public-private partnerships result in costly innovations that are inaccessible to many. Taxpayers finance the research for products sold at whatever the market will bear. In order to contain this COVID-19 epidemic, affordable testing must be available to quickly identify patients with the virus and mitigate community spread. We write to ensure that both the taxpayer investment and public health are protected in any purchases. In addition, financial burdens could leave some people to forgo testing, worsening the threat of community spread to which the Administration’s failure to be prepared with adequate testing capability has already contributed.

 

Please provide answers to the following questions:

 

  1. How much are laboratories paying for each kit and how was the reasonableness of this price determined?

 

  1. What is the estimated maximum capacity of tests that can be analyzed per day? Please include the disaggregate data for public and private labs, as well as estimated capacity in each state.

 

  1. What is the estimated cost to analyze each test and how was the reasonableness of this price determined?

 

  1. Will there be different prices depending on whether the test is analyzed by a private or public lab?
  2. Will the primary payor differ depending on the type of lab analyzing the test?

 

  1. How will HHS ensure that testing kits are made available to our health care system, including hospitals, community health centers, and long-term care facilities, will be available at a fair and reasonable price?

 

  1. How will HHS ensure that testing will be made available at little or no cost to patients, regardless of insurance status?

 

  1. How will HHS ensure that the commercial labs, hospitals, and academic institutions who determine test results will do so at little or no cost to patients, regardless of insurance status?

 

Without effective action to protect public health and smart procurement procedures, we are concerned that Americans will not be adequately protected against current and future coronavirus outbreaks. We look forward to your response to ensure that the price of a testing kit and the test itself do not threaten public health by deterring access.

 

Sincerely,

 

 

Lloyd Doggett, Jan Schakowsky, Rosa DeLauro

 

 

CC: Mike Pence, Vice President

Dr. Stephen Hahn, Food and Drug Administration Commissioner

Dr. Robert Redfield, Centers for Disease Control and Prevention Director

 

 

 

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:

 

  1. By how much has the Administration failed to meet the goal you set?
  2. How many kits have actually been shipped?
  3. By what realistic date will the “close to a million” commitment actually be achieved?
  4. What was the cause or causes of the Administration failing to keep this commitment?
  5. 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?
  6. When do you estimate that point-of-care testing will be available so that Americans can get prompt test results to determine their condition?
  7. 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.

 

Sincerely,

 

 

Lloyd Doggett, Jan Schakowsky, and Rosa DeLauro

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