Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for Them

May 18, 2021By Jeffrey K. Shapiro

You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID‑19 LDTs.  At the time, we wrote favorably about this move.  Put bluntly, the review of COVID‑19 LDTs was a waste of FDA’s scarce time and resources during the pandemic.

A few members of Congress have now waddled in 10 months letter with a letter to HHS urging that FDA immediately begin reviewing COVID‑19 LDTs again.  By now the point is moot, since FDA not only stopped reviewing COVID‑19 LDTs 10 months ago, but it has deprioritized EUAs for virtually all PCR tests that must be sent to laboratories (even those that are not LDTs).  The hot ticket these days is rapid antigen testing to satisfy other testing priorities that PCR testing is less well‑suited for, like back to work screening.

However, we cannot help but comment on some of the more dismaying aspects of this letter.  In particular, these members of Congress seem to be requesting that HHS revive a dysfunctional (and probably unconstitutional) approach to regulation of LDTs.  The letter states:  “Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliability of diagnostic tests.”  And:  “While FDA has typically exercised enforcement discretion for LDTs, allowing them to come to market without prior review, the agency has maintained that “clinical laboratories that develop [in-house] tests are acting as manufacturers subject to FDA jurisdiction under the [Federal Food Drug and Cosmetic Act].”

One would think that, as members of a great legislative body, these particular members might be at least a little concerned that FDA has been not fulfilling its “legal responsibility” under the Federal Food, Drug, and Cosmetic Act (FDCA).  Yet, they blandly acknowledge that FDA typically did not conduct premarket review of LDTs and had singled out COVID‑19 LDTs as one of the few that the agency would review.  If they sincerely believe FDA has statutory authority to conduct premarket review of LDTs, why is it acceptable to them for FDA to pick and choose which ones to review?  Since when has FDA been authorized to to abjure premarket review of a medical device whenever it chooses to do so, other than pursuant to express regulations placing a device in Class I or II and designating it as 510(k) exempt?  FDA has not followed that procedure for LDTs.

One of the most fervent aspects of the letter is an alleged concern that the absence of FDA review of COVID‑19 LDTs has led to inaccurate tests and/or tests that are not adequately validated.  Given this stated concern about test accuracy and validation, why are they only urging FDA to regulate COVID‑19 LDTs?  Logically, the stated concern would apply to all other LDTs, and not just COVID‑19 LDTs, would it not?

Summing up, the letter writers seem to think that FDA can have it both ways.  On the one hand, FDA may ignore premarket review requirements for most LDTs on whatever grounds it chooses to do so.  On the other hand, FDA may impose such requirements on COVID‑19 LDTs and perhaps a few other tests on whatever grounds it chooses to do so.  This position defers all the important jurisdictional decisions to FDA.  Apparently, the letter writers think FDA rules and their job is to hector from the sidelines when they do not like a decision.  In truth, it is the other way around.  In living memory, we had a system in which Congress enacted laws and the Executive Branch executed them.  Congress should take charge of determining the boundaries around the regulation of LDTs.  It is long past time for Congress to assert its powers and legislate on this issue.  FDA should do no more than color within the lines Congress chooses to draw.