NEW YORK (GenomeWeb) – The American Clinical Laboratory Association, a group that has historically resisted the US Food and Drug Administration's attempts to regulate lab-developed tests as medical devices, recently put forth its support for a draft bill that envisions a new regulatory framework and more clearly delineates the agency's role in overseeing aspects of test development.
In March, Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) released a discussion draft of the so-called Diagnostic Accuracy and Innovation Act, which proposes to modernize regulations by creating a new category — in vitro clinical tests — encompassing laboratory-developed tests (LDTs) and kits. The draft legislation clarifies the aspects of IVCT development, performance, and interpretation that the FDA, Centers for Medicare & Medicaid Services, and states would be responsible for overseeing.
Historically, kits have been regulated as medical devices by the FDA, while LDTs have been the province of CMS under the Clinical Laboratory Improvement Amendments. But for some two decades, the FDA has wanted to lift its "enforcement discretion" over LDTs, because the agency believes these tests are becoming technologically complex and labs are broadly marketing them without establishing their accuracy and safety.
The Bucshon/DeGette draft bill evolved out of industry-led efforts to advance a regulatory proposal that was a more favorable alternative to the draft guidelines issued by the FDA in 2014 to phase in oversight of LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. The present draft bill, however, would treat LDTs not as medical devices, but as IVCTs, and would specify that the FDA would oversee their design, development, and validation; labs performing the tests would have to follow updated federal regulations under CLIA; and medical professionals' interpretation of test results would continue to be regulated by the states.
For some time now, ACLA has been working with industry stakeholders and members of the House Energy and Commerce Committee on regulatory reform approaches for LDTs, but also continued to maintain its position that the FDA lacked the statutory authority to oversee LDTs and that LDTs should not be regulated as medical devices. ACLA had even hired lawyers to make a legal case for its position and had not ruled out taking the FDA to court if it finalized draft guidelines on LDT regulations.
However, the Bucshon/DeGette draft bill would address ACLA's concerns by changing the law, and last month, the group extended its support for the Diagnostic Accuracy and Innovation Act, calling it an "important, transparent step" toward advancing regulatory reform for lab tests. "The appropriate time has arrived to design a new, logical framework that contemplates the future of clinical laboratory diagnostics," the group said.
The statement marks an important shift for ACLA on a policy issue that is of critical interest to its membership. Building the case that LDTs aren't medical devices has been a major focus for the organization, perhaps second only to reimbursement reform. At ACLA's annual meeting earlier this year, past president Alan Mertz and successor Julie Khani both highlighted FDA's recent decision to hold off finalizing its LDT draft guidance as a victory for the organization and for the lab industry.
Now, looking to the future, "some things have changed, but a lot of things have not," said Khani, who took over the reins this year from Mertz. "One thing that ACLA has been steadfast in is that laboratory-developed tests are not medical devices and can't be regulated as such. We've been very passionate about that."
ACLA is entering a new chapter with a new leader at a time of rapid growth in the lab testing industry, driven by advances in genetics. It is estimated that there are around 60,000 genetic tests currently on the market and 10 new genetic tests enter the market daily. At the same time, a new administration entered the White House promising to lessen regulation across the board, and the Republicans, generally unsupportive of a broad expansion of the FDA's regulatory role, took control of Congress.
The political dynamic has led many industry observers to speculate that the protracted debate over whether the FDA will regulate LDTs is politically dead. Labs, dreading having to navigate the FDA premarket review process for the first time, were relieved when the agency announced after the presidential elections last year that it would not be finalizing its controversial draft guidance.
While for some, FDA's decision to pull back on regulating LDTs put a contentous debate to bed, Khani sees it as a chance for groups that were previously divided on FDA regulation to now work together on a new plan.
Earlier this year, the agency released a discussion paper outlining a framework for regulating LDTs, which it put together with extensive public comments. The plan, though not enforceable, is significantly different than its original oversight plan for LDTs, in that it would grandfather in a lot more tests, and would utilize third-party reviewers, existing standards, and proficiency testing programs under CLIA.
The FDA's discussion paper clearly showed that the agency had been listening to the lab industry's concerns about being overburdened by regulations, and this appears to have also spurred ACLA to evolve its position. "Rather than be stuck talking about LDTs are not medical devices, and FDA saying, 'Yes, they are,' and pushing for regulation in that manner, we really have an opportunity here for a diagnostic-specific solution," Khani said.
ACLA has suggested several changes to the draft bill, many of which align with the FDA. For example, though the draft bill proposes to exempt IVCTs that are on the market before the law goes into effect from premarket review, ACLA would go further and exempt these tests from premarket review, design control, registration, notification, and listing requirements. This position, ACLA points out in its comments on the draft bill, is in line with what the FDA has proposed in its discussion paper.
"It's important to think about resources," Khani said. "FDA now has a very broad portfolio, and while there are many things about the current administration and Congress that are unclear, one thing that's likely is that there won't be an outpouring of additional resources for government agencies. So, it's important [to advance] something that's focused on a smaller subset of tests."
In recommending changes to the Bucshon/DeGette draft bill, ACLA highlighted several areas where it is on the same page as the agency, for example, the extent to which lab tests have to meet FDA's quality system regulations (QSRs).
In its discussion paper, FDA recognized that because lab tests are different than kits, they only need to be assessed under QSRs for aspects of test development that aren't reviewed under CLIA, including design controls; mechanisms ensuring tests meet certain requirements through the entire testing process; and procedures for correcting quality problems. ACLA agrees that lab tests should have to meet these three quality requirements, instead of the 16 listed in the draft bill.
Labs have also been worried that every time they tweaked something in a test's protocol, they'd have to get FDA's okay. In the white paper, however, the agency proposed that as long as the labs document their process for modifying tests and make changes according to standardized protocols, diagnostics (including grandfathered tests) would be exempt from premarket review. ACLA comments to the draft bill suggests the group is in general agreement with such a strategy.
Bruce Quinn, a nationally recognized Medicare expert who advises labs and diagnostics firms, also noted a shift in ACLA's position on LDT regulation based on its comments to the draft bill. "Absent new law from Congress, ACLA could maintain the FDA doesn't have authority to regulate LDTs, and it has published some legal research supporting that view," he said. But, "if Congress passes new laws and gives FDA new legal authorities, then ACLA is on a different ball field. In that case, they will want to comment on and contribute to the new legal framework as wisely as possible."
ACLA's comments to the draft bill signals growing consensus in the broader life sciences community that diagnostics regulations need to be updated one way or another. In comments to legislators, the Personalized Medicine Coalition didn't weigh in as to whether LDTs should be overseen by the FDA or solely by CMS, but highlighted that discussions with stakeholders had revealed several principles that they agree any new regulatory framework should include, such as flexibility in requirements for test modifications and grandfathering in already marketed tests.
"The uncertain landscape regarding the regulation of LDTs stifles investment in diagnostics, upon which the future of personalized medicine depends," said PMC President Edward Abrahams. "Comprehensive statutory reform that incorporates the principles PMC has articulated — and reflects the concerns of all stakeholders — would go a long way toward encouraging investment and innovation in personalized medicine."
Thomas Sparkman, ACLA's VP of government affairs, believes that the FDA, labs, and test manufacturers are ultimately all aligned in their goal to improve the quality of care for patients, but it's difficult to achieve consensus without a common language for discussing complex regulatory issues. "One of the most difficult things in the conversations between the FDA and the laboratories is that we use a different vocabulary," said Sparkman.
The FDA has been used to speaking in terms of medical devices for 40 years, and the labs know regulations according to CLIA, which was last updated in 1988. "The endpoint is the same, but the vocabulary and the sequence of how we get there is different," he said. "It's been a process with the FDA because there's been some talking past each other."
In advancing the draft bill, he said, it'll be important to understand definitions for key terms like clinical validity and safety. "It's almost like international diplomacy," Sparkman said. "You need to make sure you have a good translator in the room to understand that 'oh, we really mean the same thing.'"
While life sciences stakeholders may be more willing to move ahead with a legislative overhaul of diagnostic regulations than they were willing to back the FDA's plan to regulate LDTs, it's unclear whether the Bucshon/DeGette draft bill will advance while Congress is preoccupied with bigger concerns, like healthcare reform. Congress is certainly aware LDT regulation is a contentious issue in the life sciences community, since there have been a number of hearings on the topic. Members of the House Energy & Commerce Committee, and the Senate Health, Education, Labor & Pensions Committee are interested in taking up the issue, Khani said, and pointed out that even the House Appropriations Committee asked the FDA not to finalize its draft guidance in the agriculture/FDA spending bill last year.
The draft bill is for discussion purposes, and though there are still areas of regulation that need to be ironed out, "we're optimistic that given that interest [in Congress] and from a broad range of stakeholders, we can come together," Khani said.