Thursday, September 13, 2018

FDA's Gottlieb Speaks Out Strongly for FDA Diagnostics Law Reform; Plus Third-Party Review & Consensus Standards & Dhealth

On September 13, 2018, FDA Commissioner Gottlieb gave a major speech endorsing substantial reforms, including new law by Congress, to help the FDA be innovating in supporting diagnostics and precision medicine.

Recall that on August 3, 2018, FDA responded to the Hill's lengthy diagnostics reform bill (DAIA) with a 60-page model of its own statutory reform for diagnostics review.  The reform would nix the legacy 510K and PMA systems for diagnostics and set up a new review paradigm.   Entry point here.

Today's speech was at the Blueprint for Breakthroughs / Precision Medicine conference sponsored by the Friends of Cancer Research (FOCR).  See agenda here.

Scott Gottlieb's speech is online at FDA here, and a rapid review by RAPS is here.

There's no question that the FDA ship is steaming to legislative reform.  Gottlieb states in part:
In pursuing a new framework for the appropriate regulation of diagnostics, there will be difficult policy decisions to make and tradeoffs on any path to legislation. We know that the FDA must be flexible and open minded to new approaches that best meet the needs of patients so that patients can have confidence in the results and the treatment that comes from it. That’s the spirit of our proposed reforms. 
FDA’s Center for Devices and Radiological Health has taken exactly this approach in providing feedback to Congress on proposed diagnostics legislation.  We have embraced a more modern, flexible approach to promote the extraordinary innovation that’s already well underway in this space, while ensuring patient protections.
In providing the contours for such a pathway to Congress, we’ve proposed new regulatory concepts that reflect some of the core principles we believe are fundamental to efforts to modernize diagnostics oversight.
He goes on to discuss key points from within the 60-page legislative "brave new model" released by FDA on August 3.


Gottlieb had flagged his interest in statutory reform for diagnostics at his ACLA speech in March 2018, here.

(!!)  Note that the "reform of diagnostics regulation to encourage innovation" as discussed above is also closer interlinked the topics I list below, particularly "third party review" and "use of consensus standards" in applications and approvals review.

Third Party Review
In other important FDA news, this week FDA released a new guideline for 3rd-party review for 510(k), under which organizations like New York State or CAP might do most of a 510(k) test review.   Here (entry point and links from RAPS).

The draft guidance document is here (22 pp) -- and see a quite interesting 16-page white paper proposing to minimize FDA interference after a 3rd party review; here.  (This minimization of FDA re-review is called, "Giving 3rd Party Reviewers the Tools They Need to Succeed."  Nice spin.)

Harmonization / Consensus Standards

Also, FDA released guidance on use of harmonization and consensus standards, here (entry point and link from RAPS).   Recall that FDA released guidances a few months ago on use of NGS clinical genetic databases as part of validation; this is at least a second-cousin to the concept of consensus standards built into FDA applications and approvals.

Digital Health

FDA also released a joint statement from Gottlieb and from the head of Devices, Jeff Shuren, on the FDA's commitment to innovative review and authorizations in digital health, here.  This particular announcement seems to be a restating of their commitment to innovation and not stopping the trains by over-regulation, but they also note they plan to create a new "Center for Digital Health Excellence" inside FDA soon.


For comparison see last year's Friends of Cancer Research conference (September 2017):   agenda here, summary here, and FDA deck here.