Amy Miller, Executive Vice President, Personalized Medicine Coalition
Listen (3:37) No position for or against regulation of LDTs
Listen (5:50) Guidance missing two pieces
Listen (4:44) Timeline has to be pushed out
Listen (5:56) What do you see as the best argument for regulation?
Amy Miller is the Executive Vice President for the Personalized Medicine Coalition (PMC) and joins us in our Special Report on LDTs Series. Though the PMC does not have a position on whether the FDA should regulate LDTs, Amy says that the stakes could not be higher.
“We see the future of personalized medicine is at stake. We urge the FDA to get this right the first time so that personalized medicine can continue to improve the quality of care that patients currently have access to,” she says at the outset of today’s interview.
Amy and her organization represent stakeholders from every side of the current debate on LDT regulation. They hear from industry, payers, providers, and labs. Amy is asking the FDA to step back, take time to respond to the recent community feedback conference, and publish supplementals that will provide more clarity to the guidance, such as how risk will be determined. Amy and the PMC would also like to see the FDA “harmonize” their language with that of CLIA, the current system in place for lab regulation.
“I absolutely think the timeline has to be pushed out,” she says. “The community needs another crack at that framework."