The laboratory sector’s movers and shakers are ratcheting up the pressure on the U.S. Food and Drug Administration (FDA) to back off of its plan to regulate laboratory-developed tests (LDTs). The FDA announced last July that it intended to regulate LTDs, with a particular focus on companion diagnostics. The agency noted that at a time when personalized medicine is gaining more of a foothold in the day-to-day medical decisions of Americans, LDTs should be more closely scrutinized to ensure that the assays do not lead to inaccurate diagnoses—which in turn could spur unnecessary procedures and care. The FDA said it would classify tests by risk, and only the assays with the greatest potential impact on patient care would be subject to premarket review and a requirement that labs report any adverse events associated with the tests. It also said it would take nearly a decade to phase in the changes. So far, the sector—which has complained about regulatory overreach—mostly appears unmoved. And while a public comment period on the draft proposal released in October runs until February, laboratory lobbying groups appear more willing to air their grievances directly with the public first before submitting them to the agency. The American […]
The laboratory sector’s movers and shakers are ratcheting up the pressure on the U.S. Food and Drug Administration (FDA) to back off of its plan to regulate laboratory-developed tests (LDTs).
The FDA announced last July that it intended to regulate LTDs, with a particular focus on companion diagnostics. The agency noted that at a time when personalized medicine is gaining more of a foothold in the day-to-day medical decisions of Americans, LDTs should be more closely scrutinized to ensure that the assays do not lead to inaccurate diagnoses—which in turn could spur unnecessary procedures and care.
The FDA said it would classify tests by risk, and only the assays with the greatest potential impact on patient care would be subject to premarket review and a requirement that labs report any adverse events associated with the tests. It also said it would take nearly a decade to phase in the changes.
So far, the sector—which has complained about regulatory overreach—mostly appears unmoved. And while a public comment period on the draft proposal released in October runs until February, laboratory lobbying groups appear more willing to air their grievances directly with the public first before submitting them to the agency.
The American Association for Clinical Chemistry (AACC) recently joined the American Medical Association—perhaps the most powerful health care lobby in the United States—and some four-dozen other groups in asking the FDA to withdraw its draft guidelines and submit them under a different set of federal rules that would require it to respond to the comments submitted and require its intended policy to be subject to an economic impact report—a process that would likely delay implementation by a number of years. The letter to FDA Commissioner Margaret Hamburg, M.D., was also signed by national laboratories Quest Diagnostics and LabCorp.
“Using the current guidance process, FDA does not have to publicly respond to comments nor conduct an economic impact analysis of the proposal—both of which inform policymakers and stakeholders as to the basis and consequences of FDA’s actions,” the AACC said in a statement. The organization said it would soon issue a formal position on the proposed regulations.
Meanwhile, the American Clinical Laboratory Association (ACLA) is taking a more combative stance. Its leadership has reiterated that the Clinical Laboratory Improvement Amendments would suffice for oversight of LDTs. ACLA recently retained two of Washington’s most powerful attorneys—scholar and federal appellate veteran Laurence Tribe and former Solicitor General Paul Clement—to represent its interests regarding the FDA and LDTs.
“The FDA’s proposal represents a sea-change in the regulation of LDTs that will have significant negative ramifications for diagnostic innovation, and in turn, for patients, physicians, and the entire laboratory community,” said ACLA President Alan Mertz. “ACLA’s decision to hire Clement and Tribe, and their decision to take this case, should be seen as an indication of the strength of our conviction that the merits favor protecting patients, labs, and physicians from this unjustified regulatory action.”
Not every organization is against the FDA regulating LDTs. John L. Bishop, chairman of AdvaMedDX, which represents manufacturers of diagnostic tests, noted that the FDA’s proposal “begins to strike a good balance between patient safety and continued innovation. Maintaining the current status quo on LDT oversight, on the other hand, would continue to permit the use of high-risk tests without sufficient clinical data and stifle investment in high-quality products that are assured to be safe and effective for patients.”
Takeaway: The laboratory sector is demonstrating willingness to stall, if not outright battle, the introduction of regulatory oversight of LDTs.
