When the World Health Organization declared COVID-19
a global health pandemic on March 11th, 2020,
it had become obvious the virus
would not be easily contained.
By then, this virus had spread undetected
for weeks to months in the United States.
During this time, the Centers for Disease Control and Prevention,
in effect, operated the nation's only
medical testing laboratory, and sole means
of monitoring disease spread.
This state of affairs was the consequence
of Food and Drug Administration decisions
both to designate CDC as the country's only
diagnostic test manufacturer,
and to preclude hospital and commercial laboratories
from testing for the SARS-CoV-2 virus.
These decisions were a continuation of policies
FDA implemented during the 2016 Zika virus outbreak
under President Obama.
In March 2016, FDA sent warning letters to
two related academic hospitals in Houston
that were testing for the Zika virus, informing them
they were manufacturing and selling an unapproved,
uncleared, and unauthorized medical device under
the Food, Drug, and Cosmetic Act.
These, and similar laboratories, had not previously
been regulated by FDA.
FDA claimed the hospitals were offering a high risk test
that because of the current public health emergency,
was appropriate for agency review.
Despite the lack of an official declaration
of a public health emergency, FDA appeared to invoke
EUA authorization authority to bring the laboratories
within its regulatory scope.
HHS Secretary Alex Azar declared a public health emergency
in the United States in response to COVID-19.
On February 5th, FDA granted CDC an EUA
for a test it had designed, including the right
to distribute the test to public health laboratories,
effectively placing CDC, along with a potential network
of public health labs running its test,
in charge of COVID-19 testing for the country.
But because of faulty design,
many public health laboratories could not
successfully validate the performance of CDC'S test,
leaving CDC as the primary provider
of testing for the nation.
CDC reported only 472 performed tests
in the United States by late February.
CDC subsequently corrected problems with its test.
However, FDA required public health laboratories
running CDC's test to send all positive specimens
to CDC to be run a second time for confirmation,
further delaying the release of results.
On February 29th, FDA, through guidance, allowed
hospitals and commercial laboratories to provide testing,
but also formalized its Obama-era policy
by requiring these laboratories to obtain EUAs
after 15 days of use, discouraging many hospital labs
from initiating testing.
Importantly, FDA's modification permitted
larger laboratories to ramp up to perform
extraordinary volumes of testing, but continued
to act as a barrier to critical local testing.
On March 16th, FDA extended its elimination of its EUA
requirement for laboratories in states
that assume responsibility for testing.
Many hospital labs took FDA's announcement as a signal
the agency is unlikely to take enforcement actions
against them and it moved ahead to care for their patients.
By late March, loosening of regulatory burdens
had unleashed our enormous private sector testing capacity.
Combating this virus continues to require creativity,
entrepreneurship, and collaboration
among medical professionals, medical technology companies,
policymakers, and regulators at the federal, state,
and local levels.
As everyone works together to contain the disease,
questions relating to FDA's testing policies continue.
How much has the lack of access to lab testing
limited our knowledge about the spread
and severity of the disease?
How do FDA testing regulations, policies,
and moves to expand the agency's jurisdiction,
fit into containment of new infectious diseases,
and medical care more generally?
What is the optimal relationship between public
and private entities?
During an emergency, should the United States
allow federal agencies and government laboratories,
designed for purposes of epidemiology and public health,
to supplant the private labs that perform
most medical testing in the country?