House E&C Committee Turns Focus to the Regulation of Diagnostic Tests and Laboratory Operations

Background

The House Energy & Commerce Committee’s Health Subcommittee held a hearing on November 17, 2015, to discuss a proposal by the Food and Drug Administration (FDA) that would broaden FDA authority on the regulation of laboratory developed tests (LDTs).

As part of the 21st Century Cures initiative, the Committee has heard from a wide range of interested parties about the important role diagnostic tests play in the advancement of precision medicine. Following a July 2014 roundtable on the topic, the FDA informed Congress of FDA’s intent to issue draft guidance documents that would alter the regulatory landscape for the review and oversight of LDTs. As with most policy proposals, there are significant differences of opinion about the FDA’s proposed approach. However, the draft guidance has served as a catalyst for conversations about the “ideal” modern regulatory framework for these unique and evolving tests and services.

In December 2014, the Energy & Commerce Committee issued a white paper, asking for feedback on what roles the FDA and the Centers for Medicare and Medicaid Services (CMS) should play in the framework. This November 17th hearing was the first time that FDA and CMS testified together for a comprehensive understanding of their areas of expertise, their current responsibilities, and what their responsibilities should be moving forward.

Currently, CMS has authority from the Clinical Laboratory Improvement Amendments (CLIA) to inspect labs and lab equipment to ensure that tests are being completed properly. However, in this system, no pre-market evaluation is done to ensure the clinical validity of the tests themselves, which brings the FDA into the issue, as they claim to have better expertise than CMS in pre-market evaluations.

Opening Statements

During the opening statements, Chairman Joe Pitts seemed to understand the importance of precision medicine, biomarkers, and diagnostic testing, asserting that the medical community “needs a regulatory environment that supports this kind of testing,” and asking the FDA how its authority of LDTs could be “clarified or improved.” Ranking Member Gene Green seemed to agree with Rep. Pitts in claiming the best way to establish a regulatory framework is through legislative action.

Testimony

Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health at the FDA, stated it was his belief and understanding that modern diagnostic tests have a much higher risk and are exceedingly more complicated than when the original legislation regarding their regulation was passed in the 1970s. He claimed that the FDA has been asked to “more actively regulate” LDTs, but when they issued a proposal in 2007 to regulate a subset of tests, labs said they wanted a more comprehensive framework. That desire for a more comprehensive framework has resulted in the upcoming final guidance.

Dr. Patrick Conway, Deputy Administrator for Innovation and Quality and Chief Medical Officer at CMS, maintained that CLIA has been working for twenty-five years and would remain relevant going forward. However, Dr. Conway is cognizant of limitations with the framework, especially the fact that it is designed to reduce harm based on where the test is performed, not the validity of the test itself. He agreed with the FDA’s stance on expertise, that the FDA is be better equipped to ensure the clinical validity of tests.

Questioning

Both Dr. Shuren and Dr. Conway warned against having both the FDA and CMS attempt to perform pre-trial evaluation of LDTs as it would likely “lead to duplication and inefficiency.” Dr. Shuren went a step further, claiming it would lead to “inconsistent standards” and make coordination between the FDA and CMS much more difficult.

Dr. Conway insisted that while his staff is not “trained to test for clinical validity,” they would still play a “critically important role” by ensuring that the labs have the right procedures, staff, and equipment in place in order to accurately complete LDTs.

Representative Michael Burgess was concerned about the FDA playing a greater role, saying, “It’s unclear to me how we can separate the practice of medicine from lab processes,” somewhat suggesting that mandated premarket approval of LDTs would potentially impose unnecessary requirements and additional costs. Representative Joe Barton agreed, bringing up the old adage,” If it’s not broke, don’t fix it.”

Rep. Marsha Blackburn’s was curious as to when we can expect final LDT guidance from the FDA. Dr. Shuren stated that the FDA planned a 2016 release – “hopefully earlier rather than later.” (See the draft guidance here.)

Dr. Shuren and Dr. Conway both asserted that a risk-based approach would be used in conducting a pre-market review. The FDA is planning to focus on clearing the high-risk tests first and then move onto moderate-risk evaluations. Importantly, under this risk-based approach, all low-risk and some moderate-risk tests would not be subject to a strict pre-market evaluation. The FDA will determine levels of risk based upon assessments of the consequences if a test were to demonstrate an incorrect result.

Several members were concerned that an adjustment in the review of diagnostic tests would lead to them being taxed differently, under the Affordable Care Act’s medical device excise tax. Dr. Shuren was unable to provide a confirmation that they would not be, instead stating that the FDA would work to maintain LDTs tax-exempt status.

Conclusion

Over the years, the FDA has pushed to regulate LDTs, all the while maintaining that the lack of oversight has resulted in real harm to patients. However, the FDA has been unable to back up those claims, save a few examples. The aforementioned recently released FDA report came up with twenty such examples, but even with those additional examples, Congress is remaining somewhat skeptical.

Congress seems concerned with the current path of progress, with some members concerned about new government regulation and others concerned about what an FDA “stamp of approval” would suggest to physicians and consumers about the accuracy of the tests. Overall, most present members offered support for some legislative action to be taken to clarify the regulatory structure of LDTs.