This is an excerpt of an 833-word article in the July 18, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Leading-edge IVCT Development (VALID) Act including an LDT regulation bill was going to sail through Congress as part of a bill to reauthorize the FDA. However, momentum has shifted, at least in part because pathologists from academic medical centers spoke up in opposition to the VALID Act.
SURPRISINGLY, SUPPORT WITHIN CONGRESS FOR GREATER REGULATION of laboratory-developed tests (LDTs) may be wavering based on a variety of factors, including strong opposition from academic medical center pathologists.
The proposed Verifying Accurate Leading-edge IVCT Development (VALID) Act, which seeks to move oversight of LDTs to the U.S. Food and Drug Administration (FDA), is attached to the Senate’s proposed FDA Safety and Landmark Advancements (FDASLA) Act. The bigger bill would reauthorize the FDA’s drug and medical device user fee agreements. (See TDR, “Passage of FDA LDT Regulation Inches Closer in the Senate,” June 6, 2022.)
The FDASLA Act went to the Senate floor on June 14 for potential amendments. However, that same day, a prime supporter of the VALID Act, Senator Richard Burr (R-NC), introduced updated legislation that stripped the VALID Act and other provisions from the larger bill. Without mentioning LDTs, Burr noted in a statement that the original FDA bill would “threaten Americans’ access to breakthrough treatments and cures and deter private sector innovation.”
The final decision on which version of the FDA bill will be voted on remained pending in Congress as of July 15. The House of Representatives passed its own version of the bill without the VALID Act.
Opponents of the VALID Act and the LDT regulation bill have long argued that moving LDT oversight under the FDA would endanger future innovative lab tests from coming to market because of the expenses and time involved with agency review. Currently, LDTs are regulated by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
VALID Act supporters 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.
It’s not clear if the VALID Act and the LDT regulation bill are losing momentum because of larger concerns about ensuring the FDA user fee bill passes on time, or whether pushback from pathologists influenced members of Congress enough to force a change.
Pathologists opposed to the VALID Act have had at least 30 phone calls with lawmakers in recent weeks, according to one insider. Also, a June 1 grassroots letter to a Senate committee from more than 290 pathologists and clinical laboratory directors asked for a series of concessions to be made for academic medical center labs under the VALID Act.
“You’re talking about huge amounts of money and effort to get a single test through a system like that,” said Jeremy Segal, MD, PhD, Associate Professor of Pathology at the University of Chicago, who was among those who attached his name to the letter.
“If that’s the system the VALID Act proposes, it’s going to be unapproachable for our labs,” Segal told The Dark Report.
Academic Pathologists’ Letter
In the letter, the pathologists proposed several actions to loosen the regulatory burden on academic medical center labs:
Remove the VALID Act from the FDASLA Act to allow more time to debate LDT oversight.
If that removal isn’t possible, enact low-cost application processes for laboratories in academic medical centers and hospitals, as well as simplified technology certifications for those labs.
If those changes aren’t possible, then exempt academic medical center labs from the VALID Act.
“We believe that the current proposed legislation fails to recognize the notable differences between testing at patient-centered, research-focused institutions versus commercially-based testing laboratories/kits and will dramatically impact patient access to critical diagnostic tests,” the letter stated. “The onerous financial and administrative demands VALID will place on our laboratories threatens to leave us insolvent and incapable of achieving our mission to provide the highest quality healthcare.”
The Senate’s Health, Education, Labor, and Pensions (HELP) Committee reviewed and marked up the FDASLA bill on June 14, and it was approved by the committee by a bipartisan vote of 13-9, according to a summary from the Association of American Medical Colleges (AAMC). The AAMC also sent a letter to the committee on June 2 opposing parts of the VALID Act.
Laboratory leaders and pathologists should note that at this point the VALID Act continues to have bipartisan support. Burr’s future stance on the larger FDASLA bill will be an important one to watch given his prior support of the VALID Act and his dissatisfaction with the FDA.
Contact Jeremy Segal, MD, PhD, at firstname.lastname@example.org
Would your lab be affected by the LDT regulation bill? Please share your thoughts with us in the comments below.