Excessive rules, regulations and paperwork impede timely medical diagnoses and treatment. It’s problematic, even in normal times. In the midst of a pandemic, it’s tragic.
Bureaucratic rules, developed years ago, have needlessly delayed desperately needed lab testing for COVID-19. The good news is that the U.S. Department of Health and Human Services (HHS) has moved to roll back some of these rules. The department recently rescinded an Obama era “guidance” that required independent research laboratories developing medical tests to be subject to the Food and Drug Administration’s (FDA) “pre-market review” process before they can deploy them for the benefit of patients. Please note that the FDA had issued this requirement as “guidance.” Issuing “guidance” is not “rule-making,” a formal process of federal regulation which involves public notice and comment and which has the force of law.
The HHS action does not mean that these independent labs are now free of government oversight and regulation. Diagnostic or other medical tests developed by research laboratories remain subject to the oversight and regulatory authority of the Center for Medicare and Medicaid Services (CMS), as stipulated by the Clinical Laboratory Improvement Act of 1988 (CLIA). Meanwhile, under the Public Health Service Act, FDA still retains the authority to remove flawed tests from the market.
According to Brian Harrison, HHS chief of staff, “This deregulatory action ensures compliance with law, is responsive to multiple Trump administration Executive Orders, is a key lesson learned, and better prepares us for future pandemics while maintaining regulatory safeguards for quality and accuracy.”
Before the HHS withdrew the duplicative FDA guidance, independent legal analysts had already made the case for doing so. Writing in the July edition of the Yale Law Journal, Barbara Evans, professor of law at the University of Florida, and Ellen Clayton, professor of law at Vanderbilt University, described the delays as deadly.
Noting that in a pandemic, “lost time mean[s] lost lives,” the professors argued that the FDA guidance ”contributed to the initial “debacle” of the U.S. COVID-19 testing program by insisting on an FDA review that “essentially duplicated the internal validation procedures laboratories already must perform under CLIA....”
The confused and cumbersome federal regulatory response directly contributed to what Evans and Clayton call the initial “testing debacle.”
Both FDA and CDC played leading roles in this bureaucratic nightmare. The FDA initially barred research teams at the nation’s leading academic and commercial labs from developing coronavirus tests. The FDA did not relax this restriction until February 29. Only then could researchers at Roche, the pharmaceutical giant, deploy their own COVID-19 diagnostic tests.
Meanwhile, the Centers for Disease Control and Prevention (CDC) had developed its own test, but it turned out to be flawed and had to be recalled. They then developed another test, but made it available only to public health authorities. Thus, researchers at Johns Hopkins, a top medical center, were denied the ability to use the CDC test because they weren’t working at a “public health” lab. In other words, the Hopkins team didn’t fit into the right bureaucratic box.
Politico reports certain unnamed “public health experts” worry that eliminating the FDA’s redundant reviews “… could lead to broad use of flawed tests.” If so, these experts must also believe that CMS, operating under the CLIA statute to regulate individual labs, is ether incapable or unwilling to do the job that Congress explicitly requires it to do.
Perhaps then, Congress should revisit the issue of the regulation of independent laboratories, but do so very carefully. As Professors Evans and Clayton observed:
Genetic, genomic and other advanced molecular diagnostic tests may raise special concerns that require tailored policy solutions. These policies, however, should be pursued without disturbing policies that have performed well for many decades for more traditional types of tests, including test for emerging infectious diseases, Before Congress acts on specific legislative proposals, there needs to be a much broader, more inclusive, nuanced, and evidence-informed dialogue about diagnostic testing policy.
Meanwhile, the Trump administration should continue, where possible, to junk outdated and legally questionable administrative requirements. This is particularly true in health care, where administrative duplication and delay is not only costly, but also deadly.
This piece originally appeared in RealClear Health