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GOVERNMENT AFFAIRS COMMITTEE REPORT

2020 ANNUAL REPORT

The Government Affairs Committee is tasked with monitoring legislation and regulations that affect
AMT members’ professional interests and informing AMT’s position on issues that merit advocacy by the
organization.

Most of the issues tracked by the committee during the past year have been at the federal level.
Although the committee’s responsibilities include state legislative and regulatory matters, the COVID-19
crisis hamstrung state legislatures this spring and summer, leaving them to deal with only the most
pressing and noncontroversial issues. Meanwhile the U.S. Congress and Federal agencies, despite
shutting their doors to the public in mid-March, have been quite busy in ways that one could not have
imagined at the start of the start of 2020.

FDA Loosens Emergency Use Authorization Rules to Spur COVID-19 Test Development

As the number of confirmed coronavirus cases ballooned in early March, the Food & Drug
Administration issued a series of guidance’s designed to prompt both clinical laboratories and
commercial test manufacturers to develop new tests to diagnose the SARS-CoV-2 virus that causes
COVID-19.

Among other measures, the FDA on March 16 authorized CLIA-certified labs that perform high
complexity testing to develop, validate, and administer COVID-19 tests without first obtaining
Emergency Use Authorization (EUA) from the agency. FDA extended a similar incentive to test kit
manufacturers. Under the FDA’s guidance, manufacturers could administer or market validated tests so
long as they notify FDA upon completion of validation and file an EUA application within 15 days of
launching the test. Normally test kits and other devices subject to FDA’s oversight cannot be marketed
until the agency acts on an application, even an EUA application.

The FDA’s policies resulted in a substantial number of new tests being developed, validated, and offered
for use beginning in mid-March and continuing through and beyond the date of this report. Despite the
explosion in the number of test systems developed, overall testing capacity remained restricted in the
U.S. through at least April due to supply-chain limitations, especially with respect to swabs and analytes
used in the testing process.

Concerns with Serological Antibody Tests – Concerns emerged in late March over the accuracy of some
serology tests that were rapidly developed to detect COVID-19 antibodies. There were also concerns
that some bad actors were fraudulently marketing COVID-19 antibody test kits for home use. The FDA
issued a consumer advisory March 20 warning against the fraudulent tests and stating that no antibody
tests had yet been approved for home use.

On April 28, the FDA announced an “umbrella” pathway for obtaining Emergency Use Authorization of
serology tests for SARS-CoV-2. Under that path, manufacturers will submit tests for validation to tests
for evaluation to an interagency testing group, currently operating at the National Cancer Institute. If
certain metrics are satisfied during the evaluations, the test will be deemed validated and granted EUA.
On May 4, in response to growing concerns over mass marketing of unapproved serology tests, some of
them allegedly fraudulent, the FDA updated its earlier guidance to require that manufacturers of
existing SARS-CoV-2 antibody tests submit EUA applications within 10 business days. Other test
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