Democrats blast HHS for allowing lab-developed COVID-19 tests to market without FDA review

Recent news that the Department of Health and Human Services (HHS) had overruled the Food and Drug Administration (FDA) to allow COVID-19 lab-developed tests to come to market without FDA review was met by major warnings from House Democrats this week.

In a letter to HHS Secretary Alex Azar, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) labeled the move a “grave mistake” that continues a months-long streak of failing to take responsibility for developing and implementing a national COVID-19 testing strategy.

“We now believe you have once again committed a grave error in overruling objections of career scientists at [FDA] by announcing that HHS would allow marketing of [LDTs] without FDA review,” the representatives wrote. “This new policy, which was made without prior notice or warning, could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect COVID-19.”

Traditionally, the FDA has required labs to seek authorization before marketing such tests during public health emergencies. Despite this, the FDA will no longer be reviewing lab-developed tests even if requested by the lab sponsor — and this applies to more than just COVID-19 tests. This follows reports from FDA Directors Jeff Shuren and Timothy Stenzel in the New England Journal of Medicine that many — nearly 66 percent — COVID-19 LDTs were found to have performance problems or poor validations by the FDA.

“We are disappointed that rather than follow this safer, more constructive approach, political leadership at HHS has chosen a reckless path, removing the requirement for LDTs to receive any review by FDA prior to their use during the worst pandemic of our lifetimes,” the representatives said. “This decision will increase the chances of false-negative results, endangering countless lives, and weakening our understanding of COVID-19 as we head into fall and winter.”

HHS’s decision was announced through a one-paragraph statement online, leaving many questions as to how the new policy will affect test developers, health care providers, and patients alike.

“The department has determined that the Food and Drug Administration will not require premarket review of laboratory developed tests absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances,” the statement said. “Those seeking approval or clearance of, or an emergency use authorization (“EUA”) for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification, or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.”

The change is scheduled to go into effect by Oct. 21.