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 regulatory oversight of LDTs.
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, LDTs are generally regulated 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. (See TDR, “Congress May Soon Act on LDT, IVCT Regulation,” Nov. 29, 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, its passage 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 what 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 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.
New Business Opportunities?
In its review of the amendments being proposed to the VALID Act provisions, National Law Review noted, “The changes in law will create investment opportunities, as new FDA legislation of this magnitude often results in business exits and consolidations (e.g., mergers between laboratories, or between laboratories and currently FDA-regulated IVD manufacturers), as well as growth of service industries that would support new regulatory efforts.
“Also, there could be strong opportunities for growth for those businesses that can anticipate, effectively advocate for, and navigate the final path of regulation as it is translated from statute to FDA regulation and guidance,” noted the National Law Review.
Should the VALID Act become law as written, it will add another complex layer of regulation for those clinical laboratories that perform LDTs. It is possible that existing LDTs may be grandfathered under the law, but labs wanting to introduce new LDTs may find the FDA’s process of review and clearance to be both expensive and time-consuming.
Bill Would Allow FDA Oversight of LDTs
SINCE 2014, THE FEDERAL FOOD AND DRUG ADMINISTRATION (FDA ) has several times issued proposed regulations and position papers discussing why and how it should be given authority to regulate laboratory-developed tests (LDTs). (See TDR, “FDA Notifies Congress That It Will Regulate LDTs,” July 21, 2014.)
Were Congress to pass the bill titled “Verifying Accurate Leading-Edge IVCT Development (VALID) Act,” a new category of lab test would be created, known as “in vitro clinical tests” (IVCL). In this category would be the commercial test kits manufactured by the in vitro diagnostic (IVD) companies and LDTs.
Medical Device Network stated that this law would, “by creating a risk-based framework … require high-risk tests, like novel assays, to go through premarket review, while lower-risk tests, like cholesterol tests, could go to market after passing ‘technological certification.’ This would be a significant change to the way IVDs are regulated right now. The law will grandfather in LDTs currently in use.”