Legislation that would have overhauled regulation of diagnostics and laboratory developed tests fell off the omnibus after House Energy and Commerce ranking member Cathy McMorris Rodgers (R-Wash.) led efforts to block the provision.
“It pretty single handedly was her and her staff that killed the deal in spite of it being bipartisan,” a person familiar with negotiations granted anonymity to discuss the talks told POLITICO. “There was a lot of effort to address the concerns of the [academic medical centers].”
Background: The push to overhaul regulation of laboratory developed tests garnered support from a variety of groups, including medical device industry group AdvaMed, Friends of Cancer Research, The Pew Charitable Trusts and former FDA Commissioners Scott Gottlieb and Mark McClellan.
“It’s very disappointing that VALID is not included in the Omnibus bill,” AdvaMed CEO Scott Whitaker said. “There was and continues to be broad bipartisan support for the policy and principle of a level playing field ensuring all tests are safe, effective and work as intended. The passage of VALID would have helped ensure there are no Theranos-type tests in the health care system. And that’s good public policy.”
During the first year of the Covid-19 pandemic, the Trump administration issued a determination that the FDA did not have the authority to regulate laboratory developed tests. The decision, which was ultimately reversed by the Biden administration in November 2021, was underpinned by a legal memo written by Trump HHS general counsel Robert Charrow that argued the FDA hadn’t undergone proper notice-and-comment rulemaking to establish authority over laboratory developed tests.
What’s next: FDA Commissioner Robert Califf and top device regulators have signaled that in the absence of congressional legislation to clarify the agency’s authorities, the FDA may pursue rulemaking to clarify requirements for laboratory developed tests.
“FDA believes that enforcement discretion policy no longer makes sense here,” Elizabeth Hillebrenner, associate director for scientific and regulatory programs in the FDA’s Center for Devices and Radiological Health, said at the MedTech Conference earlier this year.