The U.S. Food and Drug Administration (FDA) has resumed its review of laboratory-developed tests, rolling back a policy established under the Trump administration. The move is being praised in a new article published March 4 in JAMA.
The U.S. Department of Health and Human Services (HHS) in August 2020 ruled that LDTs to diagnose whether patients are infected with SARS-CoV-2 did not have to undergo review by the FDA.
This change drew "wide-ranging expressions of concern" about the future safety of LDTs, according to authors Dr. Eli Adashi of Brown University in Providence, RI, and I. Glenn Cohen of Harvard Law School in Boston, in a viewpoint published March 4 in JAMA. Regarding the rollback, HHS Secretary Xavier Becerra noted that the rule "limited FDA's ability to address certain problematic COVID-19 tests."
LDTs are a subset of IVD devices regulated by the FDA. The agency evaluates their safety and efficacy and the quality of their design and manufacture, Adachi and Cohen noted. In February 2020, as numerous LDTs for SARS-CoV-2 began to be developed, the FDA reaffirmed the requirement that all laboratories must secure emergency use authorizations for LDTs before their release. The move was an effort to curb the marketing of fraudulent SARS-CoV-2 tests, the authors wrote.
But in August of that year, HHS announced that the FDA would not require a premarket review for LDTs, stating that this decision was intended to "reduce regulatory barriers that hinder the development of novel diagnostics and reduce patient access to clinical tests."
This move prompted concern that SARS-CoV-2 LDTs would not undergo adequate vetting for quality and safety, and in late 2020, congressional leaders urged the HHS to reinstate the FDA's regulatory authority of LDTs, which Secretary Becerra did on November 15.
The HHS policy reversal is a sound decision, according to Adachi and Cohen.
"The recent reinstatement of FDA oversight over SARS-CoV-2 LDTs helps ensure that higher-quality products proceed to the market and that they do so in a timely fashion," they concluded.