WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today applauded House Appropriations Committee Chairman Harold Rogers, R-KY and Subcommittee Chairman Robert B. Aderholt, R-AL, for including report language in the agriculture-FDA appropriations bill that directs the Food and Drug Administration (FDA) to suspend efforts to finalize the LDT guidance, and instead work with Congress to develop a new pathway to regulate LDTs.
“The clinical lab community praises the leadership of the House Appropriations Committee and applauds the inclusion of report language supporting the ongoing work of the authorizing committees on a legislative solution to the regulation of LDTs,” said Alan Mertz, President of the ACLA. “The language in the bill report recognizes the need to suspend the Final FDA Guidance while Congressional authorizing committees work with laboratories, diagnostic manufacturers, providers and patients on a comprehensive framework that supports innovation and personalized patient care. This is consistent with ACLA’s position.”
The language regarding the regulation of LDTs in the report accompanying the bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for fiscal year 2017 states:
“The FDA’s draft guidance issued on October 3, 2014, titled ‘Framework for Regulatory Oversight of Laboratory Developed Tests’’ (LDTs), puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated. Such a shift deserves input from the public, and Congress has been working with stakeholders, constituencies, and the FDA to find common ground on regulating LDTs. The FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.”
“Today’s committee action marks a critical next step in supporting ongoing patient access to life-saving diagnostic innovation,” said Mertz. “ACLA maintains that the FDA lacks the statutory authority to regulate LDTs as medical devices and is committed to working with Congress, the Agency and other stakeholders on a comprehensive legislative solution.”
# # #
The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.