FDA Oversight of LDTs Delayed for Consultation with New Administration, Stakeholders

The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its laboratory-developed test (LDT) guidance document before the end of the year. In fact, the FDA confirmed Friday that it will instead work with the new administration on appropriate reforms to ensure LDTs are safe and effective.

According to a statement from the FDA, which G2 received in response to a request for confirmation of the status of the guidance document:

"The FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions."

Agency representatives had previously indicated an intent to release before the end of 2016 a final version of the draft guidance document released in October 2014. That guidance set forth a framework for FDA oversight of LDTs.

Industry reaction mostly positive
The American Clinical Laboratory Association commended the agency's decision to work with lawmakers on LDT reforms, after having vigorously opposed the draft framework—even hiring high profile legal counsel and issuing a white paper in early 2015 detailing legal arguments against the FDA's authority to impose the framework. ACLA's legal team, former Solicitor General Paul D. Clement, now a partner with Bancroft PLLC, and Laurence H. Tribe, Professor of Constitutional Law at Harvard University, prepared a White Paper asserting that: FDA regulation of LDTs is not supported in the language of the Food, Drug & Cosmetic Act (FDCA), the proposed regulation interferes with the practice of medicine, and FDA guidance flouts administrative law requirements for rulemaking.

"We appreciate the FDA's acknowledgment that stakeholder input and the ongoing bipartisan work carried out in the House and Senate is the appropriate process to advance comprehensive statutory reform of the LDT regulatory framework," said ACLA President Alan Mertz in a statement. "Today's announcement by the FDA has paved the way for a transparent discussion on meaningful reform that would protect diagnostic innovation and patient access."

Other laboratory industry stakeholders expressed similar happiness at the delay, as did congressional leaders who had been promoting alternatives to the FDA's framework, including Energy & Commerce Committee Chairman Fred Upton who stated it "was the right call" and imposing regulations "via non-binding guidance documents is not the best approach." He indicated the committee is working on bipartisan solutions and "forging significant consensus among a number of patient groups, labs, and manufacturers around a 21st century approach uniquely designed with all diagnostic tests in mind from the outset."

But not everyone is ecstatic about the delay. Andrew Fish, executive director of AdvaMed Diagnostics, a trade association serving the medical device industry issued a statement saying that "AdvaMedDx is disappointed that FDA final guidance on LDT oversight is not forthcoming at this time." Echoing Upton's comments, Fish mentioned the need for a broader look at diagnostics oversight as a whole saying AdvaMedDx was "encouraged by congressional interest" in LDT oversight "in the context of broader diagnostics reform legislation." The statement emphasizes the organization's commitment to working with all stakeholders to achieve legislation addressing "risk-based oversight of all diagnostics, including LDTs" and stated it was "imperative that this legislation recognizes FDA's critical oversight role and serves public health and innovation, and we hope FDA will share its current thinking on LDT oversight to help inform the legislative discussion."

Delayed but not forgotten
As can be seen from AdvaMedDx's reaction to the delay, continued conversation is welcomed but concern regarding LDTs isn't going away.

Health care attorney Danielle Sloane, of Bass Berry & Sims in Nashville, commented that "Laboratories are collectively breathing a sigh of relief at the FDA's announcement in conjunction with the knowledge that congressional action is also less likely to come to fruition under the new administration. However, the issues that drew the FDA's concern remain, so I expect to see continued FDA vigilance in the market, particularly with respect to direct-to-consumer marketing of laboratory tests and situations in which the ordering practitioner is affiliated with the performing laboratories."

Highlighting the same concerns Mertz mentions in ACLA's statement, Jen Madsen, MPH, a health policy advisor at Arnold & Porter in Washington, DC points out that "the FDA's announcement focuses on balancing patient protections and innovation which is really where the sticking point has been in the whole debate." She predicts that if Congress does not pass compromise legislation in the upcoming user fee negotiations in 2017, it could be a significant period of time before a revised regulatory approach emerges, given that it will take some time for the new administration to get people sworn in, including a new HHS Secretary. "One barrier to congressional action is the lack of consensus in the community" about the right path to regulate LDTs, so the situation "will remain ambiguous for at least a while." Noting various stakeholders favor modernization of CLIA in addition to or in place of heightened FDA involvement in LDT oversight [see Box], Madsen adds "the device industry has also been arguing that statutory change is needed" because the FDA's medical device regulatory framework doesn't apply perfectly to diagnostics, she says, "so there are arguments that a different review process is needed for all diagnostics, not just lab tests."

Madsen and Sloane participated in a panel presentation at G2's recent Lab Institute in Washington, D.C. (Oct. 26-28, 2016) and highlighted the FDA's growing concern about LDTs marketed direct-to-consumer as well as surveyed the number of alternative regulatory proposals being promoted in efforts to influence the structure of any regulatory oversight of LDTs.

This latest status update regarding FDA efforts is not a vast change from the agency's prior statements other than to step away from its indication it would finalize the framework this year. In December 2015, at a hearing before the U.S. House of Representatives Energy and Commerce Committee, Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, had outlined the steps the FDA planned to take going forward which included:

• Coordinating with CMS on laboratory oversight and FDA plans to develop draft guidance regarding quality system requirements for LDTs, "to provide clarity for laboratories on how they can leverage compliance with CLIA requirements to satisfy those applicable FDA guidelines";

• Working with CMS and accrediting bodies and CLIA-exempt state laboratory programs, "to identify any potential overlaps between CMS and FDA activities" and look for ways to increase efficiency; and

• "Ongoing meetings with stakeholders, including laboratories, patients, traditional IVD manufacturers, and medical practitioners."

The FDA's current comments reflect a similar path, yet simply expanded to accommodate a change in administrations.

At that same hearing, Patrick Conway, CMS deputy administrator for Innovation and Quality and chief medical officer, deferred to the FDA on the issue of clinical validity of lab tests, stating that CMS through CLIA "merely regulates how and by whom the test is conducted and reported out, rather than the scientific principles behind or the clinical validity of the test system itself." Conway explained that "CLIA does not regulate the scientific principles behind or the clinical validity of any test – that is, the ability of the test to identify, measure, or predict the presence or absence of a clinically relevant condition or predisposition in a patient." Further he added: "CMS does not have a scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly. This expertise resides within the FDA, which assesses clinical validity in the context of premarket reviews and other activities aligned with their regulatory efforts under the Food, Drug, and Cosmetic Act."