MESSAGE
| DATE | 2020-08-22 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] after a series of failures - finally the FDA is
|
FDA’s Authority to Regulate Lab Tests Is Curtailed
Thomas M. Burton
4-5 minutes
At issue are what are called lab-developed tests, or LDTs, and include
those for the new coronavirus.
Photo: angela weiss/Agence France-Presse/Getty Images
Updated Aug. 21, 2020 3:57 pm ET
The Trump administration is curtailing the Food and Drug
Administration’s ability to regulate laboratory tests—including those
for the new coronavirus—that have been developed by hundreds of
hospitals during the current pandemic.
In a statement, the Department of Health and Human Services, of which
the FDA is a part, said it is taking the action as part of a Trump
administration review of “duplicative actions and unnecessary policies”
standing in the way of patient care. It didn’t provide any examples.
President Trump has frequently claimed that the FDA is too slow and has
been delaying medical products to market. HHS Chief of Staff Brian
Harrison said the move “better prepares us for future pandemics.”
At issue are what are called lab-developed tests, or LDTs. They are
tests made mostly by teaching hospitals that take patient samples from
around the U.S.
Hospitals such as the Mayo Clinic, for example, are prime among them.
These institutions make money from evaluating blood, urine and other
samples sent in by doctors for their patients.
The change prohibits the FDA from overseeing such tests before their
marketing without an elaborate process of rule-marking.
Rep. Frank Pallone Jr. (D., N.J.), chairman of the House Energy and
Commerce Committee, called the step “deeply concerning and suggests that
the Trump administration is once again interfering with FDA’s regulation
of medical products.” The committee oversees the FDA.
The action is something the hospital lab industry has sought for years.
And yet it is mostly symbolic in the case of the current coronavirus.
That is because beginning in late March, the FDA told hospitals they
could make such tests without prior approval by the FDA, and said the
medical centers could use their tests and that the agency would evaluate
their precision after the fact.
Under the new rule, the hospitals may submit tests to the FDA for
approval but don’t necessarily need to do so.
The hospitals say they often make tests with lightning speed to catch up
with new developments in science, such as genes associated with cancer
and other disease.
The FDA has argued that a number of cases, including some erroneous
tests in the past for Lyme disease and some heart conditions, show why
the lab industry needs to be regulated.
As demand for Covid-19 testing outpaces supply, some health agencies are
narrowing recommendations for who should get a test. WSJ’s Stefanie
Ilgenfritz explains why the message about testing changed. Photo: Go
Nakamura/Getty Images
Write to Thomas M. Burton at tom.burton-at-wsj.com
--
So many immigrant groups have swept through our town
that Brooklyn, like Atlantis, reaches mythological
proportions in the mind of the world - RI Safir 1998
http://www.mrbrklyn.com
DRM is THEFT - We are the STAKEHOLDERS - RI Safir 2002
http://www.nylxs.com - Leadership Development in Free Software
http://www.brooklyn-living.com
Being so tracked is for FARM ANIMALS and extermination camps,
but incompatible with living as a free human being. -RI Safir 2013
_______________________________________________
Hangout mailing list
Hangout-at-nylxs.com
http://lists.mrbrklyn.com/mailman/listinfo/hangout
|
|
