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Sept. 9 — A Sept. 9 hearing of the House Energy and Commerce Health Subcommittee regarding the FDA's intention to issue draft guidance on laboratory-developed tests turned somewhat testy, as some Republican members accused the FDA of trying to sidestep the formal rulemaking process.
Testifying at the hearing were Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health (CDRH), and various industry, investor and patient stakeholders. Shuren faced questions from several Republican members about the FDA's intention to release draft guidance that will describe the agency's plans to oversee and regulate diagnostic tests manufactured by clinical laboratories and medical device companies.
Rep. Michael C. Burgess (R-Texas), along with other members of his party, asked Shuren if the FDA held the authority to now propose new LDT regulations without going through the formal rulemaking process. Shuren said that the changes proposed to the LDT regulations don't require the agency to follow the formal rulemaking process and that the FDA will release the draft guidance within 30 days.
Currently, the FDA regulates diagnostic tests only if they are developed and sold by device manufacturers as diagnostic kits, regardless of whether they were developed by clinical laboratory companies for in-house testing or by manufacturers for use in kits. The lab tests that companies develop internally generally aren't subject to FDA review. Instead, the Centers for Medicare & Medicaid Services regulates tests developed internally by labs, under processes outlined in the Clinical Laboratory Improvement Amendments (CLIA).
The debate over FDA regulation of LDTs has simmered for decades, according to Shuren's testimony. The FDA in 2007 issued draft guidance that would have classified LDTs as medical devices. In 2010, the FDA held a two-day meeting to gather input from stakeholders about how the agency should regulate LDTs. The issue again picked up steam in June 2013, when the American Clinical Lab Association (ACLA) sent a petition to the FDA urging the agency not to classify LDTs as medical devices.
However, the issue appears to be coming to a head this year. The Combination Products Coalition May 15 sent a letter to the FDA saying the agency needs to take action and decide whether it has the authority to regulate LDTs. More recently, a group of five Democratic senators accused the White House Office of Management and Budget of delaying the release of LDT draft guidance and sent a letter urging the Obama administration to release the document.
Shuren spent a large part of his testimony defending the agency's decision to issue guidance instead of a formal rule. While questioning Shuren, Rep. Joe Pitts (R-Pa.), the Health Subcommittee chairman, said the guidance marks a significant change of policy regarding LDTs and asked the CDRH director why the agency didn't need to follow the Administrative Procedure Act when it announced its intention to regulate tests made by clinical laboratories.
According to Shuren's testimony, all diagnostic tests have been subject to FDA regulation since the passage of the Medical Device Amendments in 1976. However, Shuren said that since 1976, the agency exercised “enforcement discretion” of LDTs—that is, the FDA generally didn't enforce applicable requirements to the tests—as they were limited in number, were relatively simple tests and typically were used to diagnose rare diseases and uncommon conditions. Shuren testified that the agency doesn't need to complete formal rulemaking because the FDA is only changing its enforcement policies for LDTs.
Several subcommittee members of both political parties asked Shuren to comment on the guidance's potential to discourage investment in diagnostic tests. Shuren responded that the FDA will continue to use its enforcement discretion and will only regulate tests that carry the highest risk.
In written testimony, Shuren said, “FDA intends to continue to exercise enforcement discretion for many LDTs—including those that are low risk, for rare diseases, and for unmet medical needs,” adding, “Our upcoming proposal would incentivize innovation, and would also support the advancement of personalized medicine by assuring that patients and their physicians can rely on LDT results for making major medical decisions.”
In addition to Shuren, the subcommittee heard from five other panelists who held a broad range of views regarding LDT regulation. ACLA President Alan Mertz testified that his group fundamentally disagrees with the FDA guidance. He said the ACLA doesn't believe the FDA holds the statutory authority to regulate LDTs and wants tests developed by labs to be approved by the CMS. Moreover, Mertz questioned the FDA's decision to promulgate new regulatory oversight of LDTs through agency guidance documents.
Meanwhile, Andrew Fish, executive director of AdvaMedDx, a trade association representing manufacturers of medical diagnostic tests, told the subcommittee that his group supports the FDA's efforts to regulate LDTs. According to Fish, the current regulatory regime for diagnostic tests creates gaps in oversight, which hurts patient safety and discourages medical device companies from developing tests. Fish, in written testimony, said, “Maintaining two very different oversight mechanisms for tests that are the same from the perspective of patient safety is bad public policy, provides an opportunity to use tests in clinical settings without sufficient clinical data, and stifles investment in high quality products that can stand up to FDA review.”
Also testifying at the hearing were Christopher Newton-Cheh on behalf of the American Heart Association; Charles Sawyers, immediate past president of the American Association for Cancer Research; and Kathleen Behrens Wilsey, the co-founder of the Coalition for 21st Century Medicine. Newton-Cheh and Sawyers testified they generally agree with the FDA's expected guidance, while Behrens Wilsey was generally opposed to FDA oversight of LDTs.
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