The U.S. Food and Drug Administration (FDA) will no longer require labs to undergo a lengthy “pre-market” review of their tests, which could improve response time to public health threats, such as the COVID-19 pandemic.
The new policy, a legal determination announced August 19 by the Department of Health and Human Services (HHS) Office of the General Council, applies to all diagnostic tests, not just those for COVID-19, and allows labs to submit to a premarket review for their tests if they wish to do so. FDA says the change is part of a process that began in January, before the pandemic.
In the early stages of the pandemic, FDA banned anyone but the Centers for Disease Control and Prevention (CDC) from developing a test for the SARS-CoV-2 virus, but after several critical weeks, failed to do so. When the clinical lab industry was allowed to step in, late February and early March, it quickly ramped up production and as of late summer, the sector conducted more than 50 million tests.
Flexibility and Safety
Loosening regulations does not have to come at the expense of safety, says Roger Klein, M.D., an expert on diagnostic testing and regulation and policy advisor to The Heartland Institute, which publishes Health Care News.
“It is important to understand that clinical laboratories are among the most heavily regulated areas in America,” Klein said.
Overseen by the Centers of Medicare and Medicaid Services (CMS), labs fall under the regulatory guidance of the Clinical Laboratory Improvement Amendment (CLIA) and by state health and safety regulations.
“New York State in particular has an extensive regulatory program under which national laboratories are also regulated,” Klein said. “CMS relies heavily on accreditation organizations to ‘deem’ laboratories compliant with CLIA.”
The College of American Pathologists (CAP) is one such agency.
“CAP is the leading accreditor of the highest complexity laboratories [in the nation], over 7,000, and uses over 1,500 checklist questions with which laboratories much comply and by which they are inspected,” Klein said.
Physicians and scientists also oversee clinical labs to make sure they are using the latest technology and testing paradigms, Klein says.
How FDA Oversight Can Hurt
FDA’s attempts to regulate lab services as “medical devices” could be dangerous to the public, as the nation recently witnessed with the delay of a COVID-19 test, Klein says.
“FDA assertion of authority over clinical laboratories set us back weeks in testing, resulting in lack of appreciation for the extent of community spread, and perhaps directly costing lives,” Klein said.
Klein says there is no evidence an added layer of regulation helps patients.
“FDA clearance and approval are expensive, document-heavy enterprises,” Klein said. “The additional manufacturing quality systems regulations are costly, bureaucratic, burdensome and duplicative of existing regulations that are more tailored to the laboratory setting.”
Response from Commercial Labs
The American Clinical Laboratory Association (ACLA) didn’t outright endorse the change, instead stating the need for regulatory “clarity and certainty.”
“We appreciate that HHS recognizes the importance of flexibility to innovate for laboratories bringing quality testing services to the market,” stated ACLA President Julie Khani. “We also believe it is critical that all laboratories developing and performing testing for COVID-19, irrespective of the regulatory authorities under which they operate, have the appropriate expertise, equipment and training to develop valid tests and deliver the accurate and reliable results that patients and clinicians depend on.”
It is important to note that ACLA is a trade organization that does not represent labs in hospital and academic centers, Klein says.
“ACLA can be expected to take a nuanced approach, especially given concerns about the limited and potentially reversible nature of the move, based on both the interests and diversity of its membership,” Klein said. “Most of ACLA’s members would probably prefer not to have FDA regulation.
Voluntary FDA Oversight
Labs can voluntarily submit to a pre-market review, and Klein says a small number are choosing to do so.
“These are almost exclusively commercial laboratories that believe FDA regulation will improve reimbursement prospects and/or confer a marketing advantage,” Klein said.
Under the new legal determination, FDA will no longer be allowed to regulate tests through “sub-regulatory guidance documents,” but must go through traditional “notice and comment” rulemaking. Klein says he believes forcing labs so submit to FDA regulation would slow down advancement in diagnostic testing.
“There is considerable political pressure from large test kit manufacturers, at times using older technologies, who sell FDA-cleared or -approved products and want to force laboratories, physicians and patients to continue to use what are often expensive, outmoded tests,” Klein said.
“The Trump administration has resisted this rent-seeking behavior by manufacturers.”
AnneMarie Schieber (amschieber@heartland.org) is managing editor of Health Care News.