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HHS Rescinds FDA’s Role in Regulating Lab-Developed Tests

By Allison Proffitt 

August 21, 2020 | After years of uncertainty over the future of laboratory developed tests (LDTs), the Department of Health and Human Services (HHS) has determined the FDA does not have the authority to regulate lab-developed tests for any condition according to a rescission posted on Wednesday.

Among conditions effected: COVID-19. Thirty-five LDTs have been granted emergency use authorization for testing for SARS-CoV-2 infections by FDA so far. The new rescission removes the need to submit these and other tests to FDA.

FDA generally traces its authority to regulate lab-developed tests back to the Medical Device Amendment in 1976, though since then the agency has exercised “enforcement discretion.” But in 2014, the FDA announced its plans to regulate laboratory developed tests in the same way it does other diagnostics. FDA argued, then, that regulations were needed because labs did not have to demonstrate that an LDT measures the outcome it claims to, did not have to report any adverse events or deaths that might be linked to an LDT, and did not have to use devices the FDA believes are clinically accurate.

Although labs offering the tests are certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and the Centers for Medicare and Medicaid Services inspects labs to make sure the personnel are well trained and equipment is functional and accurate, FDA argued that because CLIA certification must be renewed every two years, labs could release new tests between CLIA certification visits, effectively marketing tests for up to two  years without any prior assessment.

Critics—including academic lab directors at nonprofit centers—strongly opposed any FDA regulation of LDTs. In a 2014 letter, one group asserted that CLIA certification already provided “extensive validation and continuous monitoring to ensure the performance, quality and reliability of diagnostic services,” and that additional regulations could remove some tests from the market completely. “Some testing currently performed at laboratories as LDTs will never generate the financial returns to justify the costs of obtaining FDA clearance or approval,” they wrote. “Patients served by these tests would be left with no testing options,” the 2014 letter stated.

Since then, the arguments have flown back and forth, but in November 2016, FDA stood down, saying that it would put its plan on hold to regulate laboratory-developed tests, waiting instead for input from the new Presidential administration and the new Congress. The Association of Molecular Pathologists, AMP, applauded the retreat in 2016. “AMP believes this decision is in the best interest of patients, healthcare providers, and the entire field of molecular pathology,” the group wrote in a November 2016 statement.

COVID-19 Timing, Implications

This week’s announcement, though, is couched not in terms of the historic LDT debate but related to COVID-19: “As part of HHS's ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19, the department has determined that the Food and Drug Administration ("FDA") will not require premarket review of laboratory developed tests ("LDT") absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.”

The “Rescission of Guidances” is tied specifically to two Executive Orders, one from before the pandemic, 13771 (Executive Order on Reducing Regulation and Controlling Regulatory Costs published January 30, 2017), and one focused on economic recovery during the pandemic 13924 (Executive Order on Regulatory Relief to Support Economic Recovery published May 19, 2020).

The ruling would relate to all LDTs, not just COVID-19 tests, and senior administration officials told POLITICO that the policy is not specifically aimed at relaxing rules for coronavirus testing. But the timing is worrying for some during a pandemic plagued with testing issues. 

According to the HHS change posted on Wednesday, any lab seeking an emergency use authorization (EUA) for an LDT can still voluntarily submit a premarket approval application to FDA, but it is no longer required. Those with an active EUA to use an LDT to detect the virus causing COVID-19 or its antibodies are unaffected by this announcement.

The EUA designation was introduced in 2017 as way for FDA to facilitate availability and unapproved uses of medical countermeasures needed to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear agents.

Since the COVID-19 pandemic has begun, FDA has issued 175 EUAs for molecular diagnostic tests for SARS-CoV-2. Thirty-five of those tests fall under an Umbrella EUA that FDA issued on March 31, 2020, for molecular LDTs for detection of nucleic acid from SARS-CoV-2 authorized for use in a single CLIA-certified laboratory. 

In a press release issued today, AMP again applauded the deregulation of LDTs--particularly during the pandemic. AMP “commends the decision by the U.S. Department of Health and Human Services (HHS) to rescind the requirement for premarket review of laboratory developed testing procedures (LDPs) by the Food and Drug Administration (FDA),” the statement reads. “LDPs are designed and performed by molecular diagnostic professionals whose laboratories are already regulated by the Centers for Medicaid & Medicare Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). CLIA has a longstanding and successful history of promoting patient safety. This action by HHS reduces the duplicative regulatory burden placed on molecular diagnostic professionals wishing to use their expertise to provide high-quality, innovative LDPs, including those for SARS-CoV-2 in the COVID-19 Pandemic.”

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