Monday, December 10, 2018

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.