At the House E&C hearing on FDA LDT on 3/21/2024, there were two or three paragraph-long comments on the adverse effect on microbiology. (Other specialty interests including tox testing and rare diseases and pediatric special cases).
ASM submitted a written comment to the hearing.
ASM submitted 12/2023 comments to FDA:
https://asm.org/articles/policy/2023/december/asm-responds-to-fda-proposed-rule-on-laboratory-de
See also 9p pdf which includes a supplemental 3-page section of information and graphics (p 7-8-9).
IDSA had a highly negative public blog on 11/2023:
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Here are some quotes from the March 21 hearing.
Thank you, ma'am. Dr. Eisner. You know, I've heard worries that FDAs proposal could make it
more difficult to treat antibiotic resistant infections and address antimicrobial resistance and
currently FDA has no pathway for off label antibiotic test. And at Vanderbilt University Medical
Center ICUs roughly 60% of antibiotics prescribed are for off label organisms or off label
indications and use of off label antibiotics are made possible by LD T testing for antibiotic
susceptibility. How would the loss of such test affect the management of patients including those
with compromised immune systems or facing extremely rare infections?
Speaker 9 2:19:48
Thank you for the question. I think that it's quite evident that the FDA rule as proposed would
clamp down on LDTs in a way that would bring testing such as antimicrobial resistance testing
to a halt, that could leave hospitalized patients without a pathway to exiting their infectious
status. It could lead to overtreatment with multiple antibiotics in an attempt to eradicate which
can lead to kidney failure, liver failure, etc. I think that it is a huge challenge to understand the
global impact of LDTs because it is not just about oncology genetics, it's about infectious
disease. It's about rare disease. It's about anatomic pathology, it's about there isn't a field of
medicine, where LDTs aren't part of the picture. And I think it is. It is understandable that we are
talking a lot about oncology today. I for one, appreciate that perspective. But I think when you
look at the larger landscape of laboratory testing LDTs plays such a pivotal role across every
specialty.
###
Thank you for yielding. I just have a follow up question I was someone asked question about
Anna my antimicrobial resistant efforts, which is a long standing issue we've been trying to
address and Mr. Rothstein under that, under that, how do you how would you see a framework
like valid handle new anti microbial resistance tests that might come available?
Speaker 6 2:36:30
Thank you for the question. And this is a topic that's actually very well suited for the technology
certification program contemplated in VALID right now anti microbial testing, which is so
important for our nation, but for patients and for ensuring that we have antibiotics available. For
the long term requires for each test of whether it's a bacteria or a fungus, each of those tests
has to go through FDA one at a time. Under the technology certification program in valid a
manufacturer or a laboratory could develop a platform in which FDA looks at once, and then any
subsequent bacteria, fungus or other type of micro organism that needs to be detected, could
go through that platform without going to FDA as long as the parameters are met within the
agreement between FDA and the industry. And it would make the process for antimicrobial
resistance products to come to market in an extremely efficient mechanism matter. Thank
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