PEB - Pacific Edge Ltd

[Roskat]

Lengthy but worth the post I guess



Sunday, February 4, 2024

Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment

HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
###
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here.
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
https://www.thefdalawblog.com/wp-con...-12-4-2023.pdf
Topics include:

• Prohibitive costs of the rule
• Poor presentation of LDT risks and no presentation of LDT benefits
• Deeply flawed economic analyses
  
  • Multiple categories of costs ignored and underestimated
  
  
• Existing regulatory framworks are ample
• FDA lacks statutory authority
  
  • Elaborate statutory discussion

The letter makes a point I have made, the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38). ##

[Roskat]

The 58 page report. https://www.thefdalawblog.com/wp-con...-12-4-2023.pdf

[Roskat]

Vision of the Future under FDA LDT Regulation (White Paper)
The FDA's impending LDT rule, slated for finalization in April 2024, ushers in a transformative shift in the regulatory landscape for laboratory-developed tests (LDTs), bringing them under the same stringent oversight as in vitro diagnostics (IVDs). This comprehensive rule, aimed at safeguarding patient safety and ensuring diagnostic excellence, presents a critical juncture for laboratories utilizing LDTs and life science tools and diagnostic companies whose products form the backbone of LDT workflows. To effectively navigate this regulatory transition, life science tools and diagnostic companies must embark on a proactive strategy, encompassing reassessing their product portfolios, enhancing regulatory and clinical development capabilities, adhering to stringent quality standards, and maintaining close engagement with regulatory authorities. By embracing this proactive approach, they can effectively adapt to the FDA's LDT rule, positioning themselves for success in the rapidly evolving diagnostic landscape and eventually emerge as industry leaders in the dynamic clinical diagnostics arena.

[Roskat]

Very Brief Blog: FDA Sends Final LDT Rule to White House



Header: FDA Sends Finalized LDT Rule to White House OMB/OIRA
##
Moving at a fast pace, FDA has finalized its review of comments on the LDT regulation, and the final regulation was logged at the White House on March 1, 2024. Specifically, the rule is at the Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs (OIRA).

[Roskat]

About the Author

BruceBruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.

Friday, March 8, 2024

In Writing: My Prediction for FDA LDT, 2024-2031

It was big news in the past week that FDA has sents its final LDT rule to the White House for final sign-off and publication.
https://www.discoveriesinhealthpolic...final-ldt.html
I'm putting my official multi year policy forecast in writing. Here. Click to enlarge.

click to enlarge

Discussion.


First, for simplicity, I'm leaving the initial FDA timelines as published in Fall 2023, but I think it is very likely (80%) then will all advance by one year. Regardless, the court case will start immediately.


Second, I think there is a 95% (really, 100%) chance this will tie up in court for several years. Allow 2024 for federal court, 2025 for appeals court, and 2026 if not easily 2027 for Supreme Court.

Third, at Supreme Court, while I am not an attorney, I give a 50% chance the regulation will be tossed out as agency overreach and lack of clear Congressional text governing LDTs. I give a 10% chance that in 2026 or 2027, it will undergo further legal circling like being remanded to a lower court.


This leaves a 40% chance of the regulation being turned back on and its engine revved in 2027 or so.


Fourth, I predict, as in my initial white paper in October 2023, that the rule will have to bog down in several years of delays and deferrals if not worse. By 2029 or 2030 this will lead people to dust off VALID or other alternatives.


##


Offline.

Other possibilties include a 2nd Trump administration that might reverse the rule in a 90-day rulemaking (or un-rulemaking) cycle. Or might more subtly decline to defend it assertively in the court pathway, raising the chance it loses in court.





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[whatsup]

Slip sliding away and not looking good now !!

[snigmac]

Alot of the brokers have bet that the LDT decision will be finalized (in favour of PEB losing funding) and that the price will keep slipping :/

[Balance]

Slip sliding away and not looking good now !!

https://quoteapi.com/resources/da986...iPT0K1uBY8zt38

And it looks like two of the directors (including the Chairman) agree so they are quitting.

Bye bye …

[Roskat]

Published: 03.13.2024Ranking Member Cassidy Seeks Information from Stakeholders on Regulation of Clinical Tests

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WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested information from stakeholders on ways to improve regulation of clinical tests in the United States.
Clinical tests are essential health care resources, informing 70 percent of all clinical decisions through diagnosis, screening, staging, and managing of diseases and medical conditions. Since 1976, there have been no significant reforms to the regulation of clinical tests, even as new, innovative tests are being used in health care settings.
Recent efforts by the Food and Drug Administration to unilaterally pursue regulatory reforms through rulemaking go beyond its statutory authority and threaten patient access to timely care. Cassidy rebuked the Biden administration’s executive overreach and its attempt to bypass Congress on this matter.
Cassidy hopes to use the feedback on how Congress can modernize current regulations to support innovation while ensuring these clinical tests are safe and effective to use. The deadline to submit feedback is April 3, 2024.
Read the full request here or below.
To Interested Parties:
Clinical diagnostics play a critical role in our health care system, influencing nearly 70% of all health care decisions. Diagnostic technologies are also the cornerstone of precision medicine and personalized therapies, and as such warrant oversight to ensure regulators are facilitating their continued progress, safety, and accuracy.
Stakeholders and policymakers broadly recognize the need for reform to the regulatory frameworks that oversee laboratory services and diagnostic products. In the nearly 50 years since the Medical Device Amendments (MDA) of 1976 established the Food and Drug Administration’s (FDA) framework for medical devices, advancements in in vitro diagnostic (IVD) technologies have necessitated improvements to this framework to support timely patient access to safe and effective diganostics, especially those intended for special or rare disease populations. At the same time, clinical laboratory medicine has evolved in the 35 years since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted, demanding standards that reflect advancements in molecular and genomic testing and ensure appropriate oversight over these tests.
In the past, Congress has considered proposals to bring needed reforms to diagnostics regulation. These efforts have been unsuccessful and have resulted in missed opportunities to implement substantive updates to both regulatory frameworks. To further guide ongoing discussion of these matters, I welcome your insights on the following topics, specifically addressing the actions Congress should pursue to meet the challenge of ensuring patient access to timely and advanced diagnostics. Please submit any responses to diagnostics@help.senate.gov by April 3, 2024.

[850man]

A mention of CXBladder as part of in-home care at a recent meeting of the South Eastern Section of the AUA https://www.urotoday.com/conference-...er-cancer.html