December 10, 2018: Legislators Release New 200-page Draft Diagnostics Legislation

Last Thursday, December 6, FDA released a rather quirky statement on its intention to encourage innovative diagnostics while regulating LDTs.  LDTs would be regulated by new methods, risk-based, and including "pre-certification" aka self-certification.   The statement, released in a series called "FDA Voices," opened with a statement by Commissioner Scott Gottlieb, then a statement by CDRH leader Jeff Shuren, then a statement from the legal team, Lauren Silvis, focusing on hazards and risks of unregulated LDTs (bad cop?).

December 7, as publicized by Genomeweb here, the Hill has released a new 200-page version of legislation that would greatly reform the FDA's approach to clinical diagnostic tests.

• See the 200 page legislative online here.
• It's now called VALID - "Verifying Accurate Leading-Edge IVCT Development Act of 2018."
• This legislative version follows a prior draft legislative proposal in May 2017, and a 60-page FDA version of a better idea released in August 2018.
• It includes pre-certification as law, something that FDA has been proposing in speeches and pilot programs.
• Biocentury here, AACC here.  Sen. Hatch here.
• I've heard from DC experts that legislators are welcoming comments until early February, and that the 200 page bill has some holes in it, as it was put together quickly.

Can such an act possibly pass in this section?  You can assume not (a couple legislative days left.)  Sen. Hatch (retiring) regrets he will not be around, in 2019, to see the possible future action on the bill.

Stay tuned for CY2019 and a new Congress.

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Very Brief Blog: FDA Recognizes ClinGen Database for FDA Genetic Tests

Continuing its effort to smooth new pathways for FDA review of genetic tests of all types, FDA announced it has recognized ClinGen / Expert Curated Human Genetic Data as a database that may be referenced in submissions.

FDA press release (December 4, 2018) here.
For a Twitter message chain, see #fdarecognizesclingen here.

FDA cites its April 2018 guidance on use of databases in genetic test submissions.

Journals and Trade Journals 

Genomeweb covers the December 4 ClinGen story here, and cites back to a recent article in Genomeweb here about a special issue of the journal Human Mutation, here.   Volume 39, Issue 11, November 2018, had a series of open-access articles on ClinGen and Clin Var.

The Other LDT Regulatory Battle: Genetic Testing in Europe

While news about U.S. LDT regulation pops up almost weekly - there's an FDA hearing, or a legislative proposal - lab test regulation is also on the charts in Europe.

Below, the European Society for Human Genetics (ESHG) and "a range of organisations" raise concerns about in likely changes in European diagnostic test regulation.

House Hearings on FDA LDT Regulation: Key Quotes, Video, Detailed Notes

The House has posted a two hour, twenty minute video on the November 17, 2015 hearing, "Examining the Regulation of Diagnostic Tests and Laboratory Operations."  Here.

FDA Tells World (And Hill) It Needs to Regulate LDTs

On November 16, 2015, the FDA released a detailed white paper on why LDTs need to be more stringently regulated.

The FDA Blog introduces the topic, authored by Peter Lurie (here).   The FDA's homepage for the report on LDT safety and problems is here.   The FDA's 39 page white paper is here and assesses potential risks and harms associated with twenty different LDT tests.

The report went up the day before FDA will testify at a Hill hearing on the need to regulate LDTs.

Structured Risk Benefit and the Elucidation of Uncertainty

The Long Struggle to Clarity on Risk/Benefit Decisions

The FDA and international regulators have long struggled with how to assess risk/benefit issues.   For example, in 2007 the FDA's Robert Temple wrote a thoughtful essay on the disadvantages or difficulties of quantitative risk benefit analysis (article online; pubmed), in response to an article promoting the quantitative risk/benefit approach by Hughes et al.

FDASIA Report on Healthcare Software Regulation Released - April 2014

"FDASIA" was the 2013 round of new funding for the FDA.   One of its mandates was the the FDA collaborate in a multi-stakeholder effort to develop best practices for the regulation of software in healthcare - whether electronic health records, software inside medical devices, decision-assistance software, or mobile apps.   This is an area where Congressional voices have weighed in, coalitions have struck position, and relatively little concrete action has occurred - yet.

The report, released in early April 2014, is relevant to stakeholders in a whole host of fields, from telemedicine to new horizons in healthcare self-help apps.

On our Foley Hoag website, see our full review of the new 2014 consensus report: go to our  full website here.   We also provide the text as a 4-page PDF.

Is the FDA too slack or too tight?

Is the FDA too lenient or too strict?  Controlling safety or stifling innovation?

This question never goes away.   A few years ago there was a flurry of activity, both inside and outside the FDA, on the condition of, and prospects for reform of, the 510(k) device regulation pathway.   The IOM held a 2010 workshop,  followed by a 2011 report offering a "35 year perspective," and then the FDA held a public meeting (with a 134 page transcript) on the latter IOM report.