Thursday, April 4, 2024

White House: Meetings on the FDA LDT Final Rule

Header:  FDA finalized its LDT rule around March 1.  Many meetings have been scheduled via Office of Management and Budget.


FDA finalized its LDT rule around March 1 - original blog here.

OMB has scheduled fourteen publicly-listed meetings.  If available, the listings include collateral like PDFs submitted.

March 18, 2024 
ADLM (Assoc Dx Lab Med; former AACC) (4 documents including a 58 page Hyman Phelps public comment that the LDT rule is on shaky legal ground)

March 19, 2024  
AMP (Assoc Molec Pathol) (2 documents, including a 19 page deck and a 40-page 2010 report on FDA and innovation)

March 20, 2024
ARUP (3 documents)

March 21, 2024
ACMG (Amer Coll Med Genet) (2 documents)

March 22, 2024
Center for Science in the Public Interest (CSPI), (six documents)

April 1, 2024
ACLA (Amer Clin Lab Assoc) (one document, letter to OMB, 4pp)

April 3, 2024
AHA (Amer Hosp Assoc)

April 3, 2024

April 4, 2024
Childrens' Hospital Association

April 4, 2024
Coalition for Iinnovative Laboratory Testing

(Also strongly opposed VALID Act)

April 5, 2024
Associatioin of Pathology Chairs

April 8, 2024
Natera Inc

April 11, 2024
Amer Soc Microbiol (ASM)
(Many pathogen tests = LDTs)

April 12, 2024
Coalition for 21st Century Medicine (C21CM)

April 15, 2024
"CRD Associates"

April 18, 2024
College of American Pathologists

April 19, 2024
Duke University

AI Corner

I cut and pasted this rudimentary blog into Chat GPT 4 and asked for an illustration.   Below is the machine-generated text as it planned the image.

For a blog header about the FDA finalizing its LDT (Laboratory Developed Tests) rule and the series of meetings with various stakeholders scheduled via the Office of Management and Budget, let's go with a vibrant, engaging illustration. Imagine an illustration that visually represents the intersection of healthcare policy, scientific innovation, and regulatory oversight.

We could have a central motif featuring a stylized image of a magnifying glass focusing on a DNA double helix, symbolizing the LDT rule's focus on genetic testing and diagnostics. Surrounding this central image, we see a series of calendar pages with specific dates marked, representing the scheduled meetings. Each calendar page could subtly feature the logos or symbols representing the various stakeholders (like ADLM, AMP, ACLA, etc.) that have meetings scheduled, implying a broad and collaborative review process.

In the background, we'd have a faint overlay of document pages and PDF icons, hinting at the extensive documentation and public comments involved in the rule's consideration. This mix of imagery would convey a sense of meticulous examination, scientific inquiry, and the regulatory process, all crucial elements of the FDA's rule finalization and the subsequent discussions.

This illustration would serve not just as a visual summary of the blog's content but also as an inviting entry point for readers to delve into the complexities and implications of the FDA's actions and the healthcare community's engagement with these regulations. Let's create this image.