Passage of FDA LDT Regulation Inches Closer in the Senate

This is an excerpt of a 819-word article in the June 6, 2022 issue of  THE DARK REPORT. The full article is available to members of The Dark Intelligence Group.

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA the power of LDT regulation.

FDA Would Approve LDTs

The bipartisan Verifying Accurate Leading-Edge IVCT Development (VALID) Act would require the U.S. Food and Drug Administration (FDA) to review and clear LDTs—with some exceptions. 

Proponents of the VALID Act believe FDA pre-market approval is needed for in vitro diagnostic (IVD) tests because they are similar to medical devices and thus require extensive data collection. 

Opponents feel the administrative burden of seeking FDA approval will stifle LDT innovation for smaller clinical laboratories that don’t have the resources to meet the proposed new requirements.

“If enacted, the VALID Act will take years to fully implement but could have far-reaching consequences for diagnostics development and the standards for diagnostic tests in the U.S.,” the National Law Review wrote on May 8.

An LDT is a proprietary diagnostic test developed and performed by an individual clinical laboratory. LDTs often address unmet clinical needs. Currently, LDT regulation is generally managed under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). 

The VALID Act’s proposed language has been included in the Senate’s proposed FDA Safety and Landmark Advancements (FDASLA) Act. The full legislation would reauthorize the FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements.

The bill was formally introduced on May 27. Potential amendments to the language will occur in June based on feedback from FDA officials and other interested parties who provided comment earlier to a draft version of the bill. A date when senators will debate the full bill has not been made public.

The VALID Act was originally released as a standalone bill in 2021. It had some momentum before other legislative and geopolitical issues temporarily pushed it aside. However, now that it is part of the FDASLA Act, passage of LDT regulation by the FDA into law becomes more likely, the National Law Review noted.

The VALID Act takes up 263 of the 433 pages in the FDASLA proposal—more than 60% of the legislation. That figure alone should alert clinical laboratory directors and pathologists of the weight behind the LDT regulation that the VALID Act proposes. 

Lab Groups Write Congress

The National Independent Laboratory Association (NILA) sent a letter on May 21 to a Senate committee that had reviewed the VALID Act. NILA’s letter took a strong stance in expressing its concerns about the draft language in the bill. 

“Regulations that require LDTs to go through burdensome FDA approval processes will prevent patients from accessing accurate LDTs, harming or delaying patient care and limiting response to current and future public health threats,” wrote Mark Birenbaum, PhD, executive director at NILA.

Suggestion to Amend Fees

However, NILA did not call for the VALID Act and LTD regulation to be pulled from the FDASLA, but rather that amendments be made to the Act’s provisions. Those amendments included establishing a sliding scale of user fees to accommodate smaller clinical labs and allowing web-based test menus to count as part of the submission to the FDA.

The American Society of Microbiology also issued a statement on May 17 calling for changes to the VALID Act’s provisions, largely echoing NILA’s suggestions. 

Meanwhile, the College of American Pathologists (CAP) argued that while no legislation is perfect, the bill is a viable approach that addresses LDT regulation. Further, the CAP noted the labs must remember that patients are at the core of the proposed changes. 

“While some may think the VALID Act goes too far, many patient advocate groups believe it doesn’t go far enough and are actively pushing for more restrictive LDT oversight,” wrote CAP President Emily Volk, MD, FCAP. “Indeed, these groups are frustrated that strengthening the oversight of LDTs has taken so long,” she added.

Does your lab create LDTs? Please tell us your reaction to the proposed LDT regulation law in the comments below.