FDA Eyes PAHPA For LDT Reform, As It Moves Forward With Rulemaking
March 3, 2023 — Brett Meeks, Executive Director of LAB, spoke with Inside Health Policy about the regulation of Laboratory Developed Tests (LDTs) and the potential avenues for the FDA and Congress to do so.
“Brett Meeks executive director of the Laboratory and Access Benefits Coalition, told IHP that he expects the House Energy & Commerce Committee to hold a hearing on diagnostics reform if the bill is reintroduced. The bill did not go through a hearing last Congress, which Meeks said was one of the reasons there was resistance toward passing the legislation.
He said LAB doesn’t believe FDA should regulate LDTs directly, citing legal concerns about whether FDA has the authority to do so.
He pointed to draft guidance that FDA published in 2014 attempting to codify the agency’s oversight of LDTs, which prompted a battle between device makers, who wanted FDA to step in, and labs, who wanted to leave oversight to CMS. The agency ultimately scrapped the guidance.
‘They could brush off their draft guidance from 2014,’ he said. ‘I think that would cause an uproar in the industry similar to how there were opposing factions for the VALID Act. So, I don't see that as being a positive step forward’.”