Bill Summary
This legislation, called the "GAO Report on Diagnostic Tests," directs the Comptroller General of the United States to submit a report within 18 months that describes how certain entities responded to the COVID-19 pandemic in regards to developing, evaluating, and deploying diagnostic tests. These entities include laboratories, diagnostic test manufacturers, state and local governments, and federal agencies such as the FDA and CDC. The report will assess the actions taken by these entities, the coordination between federal agencies, the standards used by the FDA to evaluate diagnostic tests, and the clarity of guidance provided to the public. It will also include an assessment of the accuracy and sensitivity of available diagnostic tests. The legislation defines a diagnostic test as a product used to detect SARS-CoV-2, diagnose COVID-19, or detect specific antibodies related to the virus.
Possible Impacts
1. The legislation could affect laboratories, both public and private, by requiring them to report on their actions in response to the COVID-19 pandemic, including the development, evaluation, and deployment of diagnostic tests. This could potentially impact their workflow, resources, and priorities, as they may need to allocate additional time and resources to comply with the reporting requirements.
2. Diagnostic test manufacturers may also be affected by this legislation as they would need to provide information on their involvement in the development and evaluation of diagnostic tests related to COVID-19. This could potentially lead to increased scrutiny and regulation of their products, as well as impact their operations and supply chain.
3. The legislation could also affect individuals without medical training, as it requires the report to assess the clarity of federal agency guidance on testing and whether it can be easily understood by non-medical professionals. This could potentially impact the public's understanding and trust in the testing process, as well as their access to accurate information about diagnostic tests.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6839 Introduced in House (IH)]
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116th CONGRESS
2d Session
H. R. 6839
To direct the Comptroller General of the United States to submit a
report describing the response of certain entities to the COVID-19
pandemic with respect to the development, regulatory evaluation, and
deployment of diagnostic tests.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 12, 2020
Ms. Spanberger (for herself and Mr. Gonzalez of Ohio) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To direct the Comptroller General of the United States to submit a
report describing the response of certain entities to the COVID-19
pandemic with respect to the development, regulatory evaluation, and
deployment of diagnostic tests.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. GAO REPORT ON DIAGNOSTIC TESTS.
(a) GAO Study.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor and
Pensions of the Senate a report describing the response of entities
described in subsection (b) to the COVID-19 pandemic with respect to
the development, regulatory evaluation, and deployment of diagnostic
tests.
(b) Entities Described.--Entities described in this subsection
include--
(1) laboratories, including public health, academic,
clinical, and commercial laboratories;
(2) diagnostic test manufacturers;
(3) State, local, Tribal, and territorial governments; and
(4) the Food and Drug Administration, the Centers for
Disease Control and Prevention, the Centers for Medicare &
Medicaid Services, the National Institutes of Health, and other
relevant Federal agencies, as appropriate.
(c) Contents.--The report under subsection (a) shall include--
(1) a description of actions taken by entities described in
subsection (b) to develop, evaluate, and deploy diagnostic
tests;
(2) an assessment of the coordination of Federal agencies
in the development, regulatory evaluation, and deployment of
diagnostic tests;
(3) an assessment of the standards used by the Food and
Drug Administration to evaluate diagnostic tests;
(4) an assessment of the clarity of Federal agency guidance
related to testing, including the ability for individuals
without medical training to understand which diagnostic tests
had been evaluated by the Food and Drug Administration;
(5) a description of--
(A) actions taken and clinical processes employed
by States and territories that have authorized
laboratories to develop and perform diagnostic tests
not authorized, approved, or cleared by the Food and
Drug Administration, including actions of such States
and territories to evaluate the accuracy and
sensitivity of such tests; and
(B) the standards used by States and territories
when deciding when to authorize laboratories to develop
or perform diagnostic tests;
(6) an assessment of the steps taken by laboratories and
diagnostic test manufacturers to validate diagnostic tests, as
well as the evidence collected by such entities to support
validation; and
(7) based on available reports, an assessment of the
accuracy and sensitivity of a representative sample of
available diagnostic tests.
(d) Definition.--In this section, the term ``diagnostic test''
means an in vitro diagnostic product (as defined in section 809.3(a) of
title 21, Code of Federal Regulations) for--
(1) the detection of SARS-CoV-2;
(2) the diagnosis of the virus that causes COVID-19; or
(3) the detection of antibodies specific to SARS-CoV-2,
such as a serological test.
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