Post by icemandios on Nov 20, 2023 16:19:22 GMT
AMP Petitions Congress to Revisit CLIA Update, Eyes Legal Action Against New Proposed FDA LDT Rule
Nov 18, 2023 | Andrew P. Han
SALT LAKE CITY – The Association for Molecular Pathology has asked Congress to revisit the idea of updating the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to a recently proposed rule by the US Food and Drug Administration that would regulate laboratory-developed tests as medical devices.
Nevertheless, the organization is bracing for the FDA to push through the rule and is preparing legal action to challenge the agency.
AMP officials provided this update during a Friday afternoon session at the organization's annual meeting concerning its advocacy efforts.
On Nov. 1, AMP sent a letter to Sens. Bernie Sanders and Bill Cassidy, chair and ranking member of the Senate Committee on Health, Education, Labor and Pensions, and Reps. Cathy McMorris Rodgers and Frank Pallone, chair and ranking member of the House Energy and Commerce Committee, to express "significant concerns" about the FDA rule, proposed in late September. Approximately 50 other organizations cosigned the letter.
"We stand united in support of modernizing the oversight framework for high-complexity clinical LDTs but primarily through reform of the long-standing CLIA," AMP wrote. Such a course "could better achieve a sustainable system that fosters innovation and promotes emerging medical knowledge to enable healthcare professionals the ability to offer precise, accurate, and the most up-to-date tests to patients," the letter said.
Joining AMP in signing the letter were the American College of Medical Genetics and Genomics, the National Society of Genetic Counselors, Invitae, Kaiser Permanente, ARUP Laboratories, Cedars-Sinai, Nationwide Children's Hospital, among others.
"We urge Congress to direct the FDA to pause rulemaking on LDTs and instead, renew bipartisan efforts to work with stakeholders to pass legislation that would establish a modernized approach within the existing regulatory framework under CLIA," the letter said.
But the organizations opposing the proposed rule do not have a lot of time to change the FDA's course. The comment period for the rule ends in early December.
"FDA is motivated to push this through quickly," Karen Weck, director of the molecular genetics laboratory at the University of North Carolina School of Medicine and vice-chair of AMP's professional relations committee, said in the conference session. "They want to get this through."
While AMP officials asked members to register their opposition officially, Weck said "there probably will be a lawsuit."
Eric Konnick of the University of Washington Department of Laboratory Medicine and Pathology noted that a lawsuit can't be filed until the rule is finalized, but suggested that could be as soon as the first quarter of 2024.
While AMP and other organizations could pursue an injunction, there may also be a period of time where labs would have to abide by the new rule.
Nov 18, 2023 | Andrew P. Han
SALT LAKE CITY – The Association for Molecular Pathology has asked Congress to revisit the idea of updating the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to a recently proposed rule by the US Food and Drug Administration that would regulate laboratory-developed tests as medical devices.
Nevertheless, the organization is bracing for the FDA to push through the rule and is preparing legal action to challenge the agency.
AMP officials provided this update during a Friday afternoon session at the organization's annual meeting concerning its advocacy efforts.
On Nov. 1, AMP sent a letter to Sens. Bernie Sanders and Bill Cassidy, chair and ranking member of the Senate Committee on Health, Education, Labor and Pensions, and Reps. Cathy McMorris Rodgers and Frank Pallone, chair and ranking member of the House Energy and Commerce Committee, to express "significant concerns" about the FDA rule, proposed in late September. Approximately 50 other organizations cosigned the letter.
"We stand united in support of modernizing the oversight framework for high-complexity clinical LDTs but primarily through reform of the long-standing CLIA," AMP wrote. Such a course "could better achieve a sustainable system that fosters innovation and promotes emerging medical knowledge to enable healthcare professionals the ability to offer precise, accurate, and the most up-to-date tests to patients," the letter said.
Joining AMP in signing the letter were the American College of Medical Genetics and Genomics, the National Society of Genetic Counselors, Invitae, Kaiser Permanente, ARUP Laboratories, Cedars-Sinai, Nationwide Children's Hospital, among others.
"We urge Congress to direct the FDA to pause rulemaking on LDTs and instead, renew bipartisan efforts to work with stakeholders to pass legislation that would establish a modernized approach within the existing regulatory framework under CLIA," the letter said.
But the organizations opposing the proposed rule do not have a lot of time to change the FDA's course. The comment period for the rule ends in early December.
"FDA is motivated to push this through quickly," Karen Weck, director of the molecular genetics laboratory at the University of North Carolina School of Medicine and vice-chair of AMP's professional relations committee, said in the conference session. "They want to get this through."
While AMP officials asked members to register their opposition officially, Weck said "there probably will be a lawsuit."
Eric Konnick of the University of Washington Department of Laboratory Medicine and Pathology noted that a lawsuit can't be filed until the rule is finalized, but suggested that could be as soon as the first quarter of 2024.
While AMP and other organizations could pursue an injunction, there may also be a period of time where labs would have to abide by the new rule.
"To be frank, it's an unknown what we're going to be facing," Konnick said.