Thursday, March 2, 2023

Brief Blog; FDA Regulation of LDTs, Balls Still in Motion, Update for March 2023

 Right through last December, the end of the two-year legislative session when bills expire, the VALID act was in play on the hill and among dueling stakeholders.  See blog December 14, 2022.  Recall that in October 2022, FDA leaders said they would regulate LDTs by FDA regulation, even if not given such authority by a new statute.  Politico covered here.

The balls are still bouncing on the court.  Dark Daily has an updated open access review of the topic, dateline February 27, 2023, here.

Just 48 hours later, FDA's Elizabeth Hillebrenner announced at the annual ACLA meeting that FDA was indeed planning to move straight ahead with regulation of LDTs by its own regulations, without needing any act of Congress.   Subscription discussion at BioWorld here.  See open access at Medtech Dive here.  Hillebrenner had made similar comments in a webinar in mid February (here).

Recall that Hillebrenner had been a spokesperson for FDA's concerns about LDT Pharmacogenetics in 2020.  She is chief of staff and associate director for scientific and regulatory programs at FDA's Center for Device and Radiological Health.