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GPPC Says HHS Committee Fails to Address FDA's 'Arbitrary' Oversight of Genetic Tests

NEW YORK (GenomeWeb News) - The US Food and Drug Administration’s regulatory approach toward laboratory-developed tests unfairly favors some manufacturers, and this imbalance was not sufficiently discussed during a recent meeting of the HHS Secretary’s Advisory Committee for Genetics, Health, and Society, according to Kathy Hudson, director of Johns Hopkins University’s Genetic Public Policy Center.
Speaking during the public comments portion of the meeting, held this week to finalize SACGHS’ report on federal oversight of genetic tests, Hudson said that the committee’s “discussion was troubling in [that] there was a constant refrain that increased oversight will stifle innovation.” SACGHS expects to finalize the draft report, called “US System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS,” by March and plans to submit it to the HHS Secretary by the end of April.
Hudson challenged that there was no evidence that increased FDA oversight of LDTs would hinder innovation of IVD kits. To the contrary, at the meeting, a group representing diagnostics manufacturers, Advamed, said that FDA’s current approach hinders innovation. Advamed, GPPC, and many developers of IVD test kits are of the view that FDA’s current policy of exercising discretion when regulating LDTs gives an unfair advantage to laboratory test developers.
Traditionally, the FDA has practiced “enforcement discretion” over most laboratory-developed tests, which fall under the aegis of the Centers for Medicare & Medicaid Services. But according to the GPPC and others, there are gaps in this system.
As reported in GenomeWeb Daily News’ sister publication Pharmacogenomics Reporter earlier this month, coalitions of diagnostic firms, clinical labs, venture capitalists, and non-profit groups find the FDA’s regulatory approach toward LDTs arbitrary, unfair to test kit manufacturers, and a hindrance to innovation. Groups such as GPPC, Genetic Alliance, and the Coalition for 21st Century Medicine have petitioned the agency to consider alternative regulatory strategies they feel ensure the safety of tests but are more market friendly.
“IVD manufacturers face major disincentives to produce validated test kits,” Hudson said during this week's meeting. “The problem is that for any test kit the manufacturer can submit data to FDA and go to market. But the very next day, Joe’s Tests R Us can offer the very same test or make identical claims without having the oversight from FDA.”
Hudson urged the committee to level the playing field for companies that are innovating and doing the work necessary to get FDA approval.
In its report, SACGHS agrees with the FDA’s flexible approach to regulating LDTs. While the committee felt that “applying the same regulatory framework to every genetic test is infeasible” from a time and cost perspective, it did suggest “further analysis … to determine whether appropriate weight has been apportioned to risks associated with the novelty and complexity of the testing platform and technology.”
The FDA has expressed its intent to regulate a subset of LDTs, called in vitro diagnostic multivariate index assays, reasoning that these tests are more complex. The agency is in the midst of finalizing a guidance on its oversight of IVDMIAs.
However, groups such as the Coalition for 21st Century Medicine do not favor this type of piecemeal approach. Instead, they have urged a phased regulatory approach that would require manufacturers to register all LDTs in a publicly accessible site prior to marketing. After data has been collected for a period of roughly three to five years through this database, then the FDA should make a decision as to whether a 510(k) or pre-market approval is necessary.
In the report, SACGHS asked the FDA to collaborate with CMS to develop such a database of all LDTs, and convene a meeting of stakeholders to discuss what types of data test manufacturers would have to submit for this database.
SACGHS Chair Reed Tuckson, who also is executive VP of UnitedHealth Group, noted that the final guidance should reflect that the committee feels the FDA should “not be screwing around, sitting on its hands, waiting until some committee” reviews this issue of LDT regulation. “The sense of urgency regarding [regulation of LDTs] within the committee is pretty clear,” Tuckson said.
“I think what we can say is that the FDA needs to tackle” the regulation of LDTs and “the bottom line is that all LDTs must be safe, must be sufficiently regulated and we can tell them that there are gaps here and this needs to be done post haste,” James Evans, SACGHS member and associate professor of genetics and medicine at the University of North Carolina, Chapel Hill, added. “As far as triaging which ones they feel are in urgent need of oversight, that’s something the FDA has been doing for a long time … [but] I think there is nothing wrong with saying that all LDTs need to be addressed.”
Ultimately, the committee recommended that HHS convene various federal agencies, as well as the FDA and CMS, and provide input on the development of a risk-based framework for the regulation of LDTs.
Committee members particularly expressed concern regarding the gap in oversight of certain direct-to-consumer genetic tests.
“There is insufficient oversight of laboratories offering such tests and their potential impact on the public health is an increasing concern,” SACGHS states in the report. “CLIA regulations, or if necessary, CLIA’s statutory authority, along with FDA’s risk-based regulatory authority and regulatory processes should be expanded to encompass the full range of health-related genetic tests, including those directly offered to consumers.”
Hudson noted that the GPPC was looking into currently marketed DTC tests to compare their use with the types of claims they make.
However, Hudson warned that the committee should not “make DTC tests the scapegoat here. There is a much bigger problem with all LDTs, and it would be misleading to point the finger solely at DTC providers.”

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