Senate health committee Chairman Lamar Alexander (R-TN) floated creating a new regulatory agency to oversee lab-developed tests, which he told lawmakers would be preferable to the current duplicative regulation by CMS, FDA and state regulators. He also told reporters he hoped FDA would not release a final version of its controversial draft guidance bringing LDTs under the medical device regulatory scheme, given Senate and House efforts to address the issue.
The committee held a hearing Tuesday (Sept. 20) to weigh how current and proposed ways of regulating such tests could impact their development and patient access. Alexander in prepared remarks said FDA’s draft guidance, if finalized, could cause patients to lose access to tests until they are approved, adding it is not known how many labs would have the resources to put their tests through the approval process.
The hearing came almost a year after House lawmakers floated legislation that would place in vitro clinical tests under a new center within FDA. The government relations director of the Infectious Diseases Society of America, Jonathon Nurse, said at a briefing after the Senate hearing that a third draft is under development of this legislation.
Additionally, Alexander said in his remarks Tuesday that the chair of the Department of Laboratory Medicine at the University of Washington wrote to the committee suggesting the proper approach would be to modernize the Clinical Laboratory Improvement Amendments under CMS jurisdiction. Nurse also said the Senate health committee is said to be working on a proposal that may include CLIA modernization approach.
Alexander, throughout the hearing, pointed to testimony given by David Klimstra, chairman of the Department of Pathology at Memorial Sloan Kettering Cancer Center, who said his institution couldn’t afford the costs associated with formal FDA review, and would be forced to close the lab if FDA approval were required. According to Klimstra’s written testimony, the cancer center already has to provide a detailed description of new tests to the New York State Department of Health and must comply with CLIA requirements.
Alexander said it doesn’t make sense to slow the use of laboratory tests.
“We’re in a rapidly changing world here but it has been changing longer than the last year or two. Laboratory-developed tests are well established and it’s clear we have two areas of regulation already. It doesn’t make sense to me to solve the problem by slowing down the use of laboratory tests so they can be at the same slow pace of kits…I think our goal is to speed up development of safe and effective kits so that institutions may use them while the patients are still alive,” said Alexander.
But Ranking Democrat Patty Murray (WA) said the current regulatory scheme sets up an uneven playing field that discriminates against in vitro diagnostic manufacturers who go through the FDA approval process.
Brad Spring, vice president of regulatory affairs and compliance for BD Life Sciences, told the senator there was nothing preventing LDT developers from making the same claims as an FDA-cleared test.
“That sets up an uneven playing field that undermines public trust and the sustainability of innovators in this diagnostic field. It kind of seems like to me if we want precision medicine to advance we need to make sure we’re incentivizing innovation and assuring patients their test will work as promised,” said Murray.
Toward the end of the hearing, Alexander suggested that sometimes it is easier to take an old structure and “tear it down.”
“How much regulation is enough regulation,” he said. “Do we want to have CLIA plus the FDA plus the state regulation, or de we want to create a new regulatory agency and phase it in over time so that we meet all our objectives of patient access, safe and effective?”
Alexander further asked, “Why not start from scratch?”
Jeff Allen, president and CEO of Friends of Cancer Research, told the senator he agreed that duplicity should be limited, but asserted that FDA should have a critical role in the oversight of these tests because the agency has the medical personnel with an understanding of the underlying disease.
But Alexander noted FDA’s struggle to hire and retain scientists, which he said could slow work in the area of diagnostics as the agency tries to make its way through all the new applications.
Nurse later told Inside Health Policy said that was the first time he had heard such a proposal, and that IDSA’s focus has been on strengthening the existing CLIA system.
AdvaMedDx, the diagnostic arm of the Advanced Medical Technology Association, maintained its support of FDA’s approach, but stressed in a statement to the committee Tuesday that FDA guidance on LDTs and legislative reforms are not mutually exclusive.
“The issuance of FDA final guidance would not preclude congressional action. Rather, it would inform stakeholders’ understanding of how the Agency intends to act in this area and ensure that LDT oversight is not further delayed while Congress continues to explore the possibility of making broader changes to the statutory framework for regulation of all diagnostics,” the group said.
Meanwhile, the American Clinical Laboratory Association wrote to the committee applauding lawmakers for holding the hearing and outlining key principles for any new statutory framework.
ACLA asserted that LDTs are not medical devices and should not be regulated as such. LDTs introduced prior to enactment of a new framework must be grandfathered from any premarket review or design control requirements, and laboratories must be granted a reasonable transition period after enactment, the group said.
ACLA also insisted that statutory and regulatory provisions developed under a new framework should be designed to avoid duplication of oversight of test development and laboratory operations to ensure continued patient access to clinical laboratory services.
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