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These oversight schemes could irrevocably damage the ability of laboratories to meet patient testing needs

ASCP recently submitted congressional testimony opposing , or VALID Act, and the U.S. Food and Drug Administration’s recent claiming oversight authority over laboratory developed tests (LDTs). ASCP’s comments were submitted to the House Energy and Commerce Subcommittee on Health prior to its March 21 hearing on the oversight of LDTs. This advocacy follows ASCP’s successful efforts to block congressional consideration of the VALID Act last year, when ASCP members sent more than 10,000 messages to Capitol Hill opposing the legislation.

Both the VALID Act and the FDA proposed rule would undermine the ability of clinical laboratories in hospitals and academic medical centers to provide patients with access to these potentially lifesaving laboratory services. Almost all laboratory and/or pathology organizations oppose these proposals, with the notable exception of the College of American Pathologists which testified before the Subcommittee in support of the VALID Act.

In ASCP’s comments to the Subcommittee, ASCP President Robert Goulart, MD, MASCP, noted that “the overwhelming majority of LDTs have a solid track record of advancing patient care safely and effectively. . . We do not agree that this requires the extraordinary level of regulatory oversight outlined in either the U. S. Food and Drug Administration’s recent Proposed Rule or [the VALID Act].” ASCP supports modernizing the CLIA regulations to address any potential concerns about LDT test performance. The CLIA regulations, for example, could be updated to require evidence of clinical validity without the need for new legislation.

Prior to the hearing, House Energy and Commerce Committee Chair Cathy McMorris Rodgers and Health Subcommittee Chair Brett Guthrie released a hearing notice that observed, “The FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input. The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases. Any paradigm-shifting changes to the current regulations must come from Congress—not the Executive Branch.”

During the hearing, one member of Congress cited testimony submitted by the American Hospital Association that stated, “One large health system [has] at least 1,600 existing LDTs; under the proposed rule, they would need to submit 1,600 applications for approval in the first year of the phase-in.” Given the FDA’s expectations that 50 percent of LDTs would have to undergo the highly bureaucratic premarket-approval process, the this healthcare system would have to pay FDA for tests going through the PMA process could approach $400 million (not counting lost staff time to support FDA applications and consulting/legal expenses). In addition, the 50 percent of tests that would not go through the PMA process may still have to pay a fee to FDA–possibly the 510(k) fee of $21,760 per submission. However, if the test submission is reviewed by one of FDA’s accredited organizations, the whole fee is captured by that entity, not the FDA.

ASCP agrees with sentiments previously outlined by Congressman Michael C. Burgess, MD, a member of the subcommittee, the longest-serving physician in Congress, and the author of a 2014 CLIA-centric bill, to increase the oversight of LDTs through CLIA modernization. In support of his legislation, Representative Burgess said, “Applying FDA’s regulatory approach to LDTs is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA. To the extent concerns about ‘higher-risk’ tests exist, these can be addressed at no cost to the government through a modernization of The Clinical Laboratory Improvement Amendments (CLIA).”

The FDA’s Final Rule is currently under review by the Office of Management and Budget, and it could be released by the FDA before the end of April. It is expected that if the FDA releases its Final Rule, litigation will be filed challenging the FDA’s authority to provide oversight of LDTs.  ASCP will be working with the rest of the laboratory and pathology community in opposition to the VALID Act and the FDA Proposed Rule.

For ASCP’s overview of the FDA’s Proposed Rule, click here.

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