Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority
When history is written, acceleration of the longstanding effort to eliminate the authority of the U.S. Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs) may be remembers as one of the unexpected impacts of the COVID-19 pandemic. The public health emergency underlined the need to bring innovative new diagnostic tests to market […]
When history is written, acceleration of the longstanding effort to eliminate the authority of the U.S. Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs) may be remembers as one of the unexpected impacts of the COVID-19 pandemic. The public health emergency underlined the need to bring innovative new diagnostic tests to market more expeditiously. In fact, many of the most significant COVID-19 tests to receive Emergency Use Authorization were LDTs created by Quest, LabCorp, Abbott and other major testing laboratories. And now the epicenter of the movement may be shifting back to Congress with the reintroduced of the so-called VITAL Act.
The VITAL Act
First introduced by Senator Rand Paul (R-KY) in March 2020, the Verified Innovative Testing in American Laboratories (VITAL) Act would transfer the source of regulation of LDTs from the FDA (under the Food, Drug & Cosmetics Act (FDCA)) to the Secretary of the US Health and Human Services (HHS) (under the Public Health Services Act). While it may sound like legal nuance, this is important because it would end once and for all the FDA’s claims that its regulatory authority over medical devices under the FDCA extends to LDTs.
Paul, who also introduced the most recent version of the bill, and supporters of the bill believe that VITAL is necessary to update CLIA by removing LDTs from FDA oversight in light of the slow federal response to expand access to SARS-CoV-2 virus tests during the pandemic. The FDA has been criticized for requiring test developers and manufacturers to get EUA from the agency prior to launching testing. “When we face a health emergency, government should trust academic, community and public health labs to do what they are already trained and certified to do,” noted Senator Paul in a press release at the time. “With all of the debates about how government should respond, here’s one thing it can stop doing: piling counter-productive bureaucratic hurdles in the way of our medical professionals.”
Subsequent FDA management of the EUA process seemed to vindicate and strengthen the drive to get the agency out of the business of regulating LDTs. In August 2020, HHS issued a determination stating that the FDA cannot require premarket review of LDTs without notice and comment rulemaking. While not eliminating FDA regulatory authority over LDTs, the HHS determination barred the agency from its traditional—and to most in the industry—infuriating practice of exercising that authority via website guidelines and other informal pronouncements serving as shortcuts around the burdensome notice and comment rulemaking protocols.
Laboratory Industry Support for VITAL Act
The VITAL Act had and now continues to have widespread support from the diagnostics industry. The day after Senator Paul re-tabled the bill, the Association for Molecular Pathology (AMP) and Association of Pathology Chairs (APC) issued statements supporting its passage.
“This important support by members of Congress for the VITAL Act addresses the serious consequences experienced by our nation when laboratory tests are regulated like medical devices,” noted APC president Lydia Howell.
“In the earliest and most frightening days of the pandemic, CLIA-accredited academic clinical laboratories could have used their valuable expertise and resources to expand SARS-CoV-2 diagnostic testing in their communities, but were unable to do so due to inappropriate FDA restrictions,” she continued. “Priceless weeks were lost, making the urgency to address these issues now even more clear.”
Here are some of the key new FDA EUAs and clearances announced in May and late April:
New FDA Emergency Use Authorizations (EUAs) & Approvals
|LabCorp||EUA for Pixel by Labcorp COVID-19 PCR Test Home Collection Kit expanded to allow for use by children and adolescents at least 2 years of age|
|Molzym||Breakthrough Device Designation for molecular diagnostic test system for diagnosis of bloodstream infections|
|Zeus Scientific||EUA for ELISA SARS-CoV-2 Total Antibody Test System|
|Qiagen||EUA for QiaReach Anti-SARS-CoV-2 Total Test to identify if person has SARS-CoV-2 antibodies from a prior infection|
|InBios International||EUA for point-of-care SCoV-2 Ag Detect Rapid Test for SARS-CoV-2 antigens|
|Viome||Breakthrough Device Designation for mRNA analysis and AI saliva-based oral and throat cancer detection technology|
|Quadrant Biosciences||Breakthrough Device Designation for Clarifi ASD assay to detect markers of autism spectrum disorder|
|Roche||Clearance for Ventana MMR RxDx immunohistochemistry panel as companion diagnostic to select endometrial cancer patients for treatment with dostarlimab|
|PathogenDx||EUA for molecular DetectX-Rv SARS-CoV02test|
|Southern California Permanente Medical Group||EUA for SCPMG’s Kaiser Permanente High Throughput SARS-CoV-2 Assay|
|Inova Diagnostics||EUA for Quanta Flash SARS-CoV-2 IgG chemiluminescent immunoassay|
|Immunodiagnostic Systems||510(k) clearance for IDS Cortisol assay to detect cortisol in human serum and plasma on firm’s IDS system|
|Retractable Technologies||510(k) clearance for EasyPoint Blood Collection Plus blood collection tube holder|
|Immunalysis||510(k) clearance for Sefria PCP Oral Fluid Enzyme Immunoassay|
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