Whether you dreaded it or craved it, you will not be getting it—at least not any time soon. In the wake of the election, the U.S. Food and Drug Administration (FDA) let it be known that it will not issue final guidance on laboratory-developed tests (LDT) in December. The FDA said that it will put the guidelines on ice and work with the new administration on appropriate reforms to ensure LDTs are safe and effective.
There was no big announcement. Word of deferral came in a statement that G2 received from the FDA in response to a request for clarification on the timing of guidelines finalizing draft guidance issued in October 2014. As you can see, the FDA response was fairly nondescript for an issue of such magnitude:
- "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."
And so the wait continues.
Industry Reaction Mostly Positive
Although the lab industry generally wants guidance, response to the October 2014 draft guidance was far from enthusiastic. As a result, reaction to the FDA’s deferral was largely positive. For example, the American Clinical Laboratory Association (ACLA) praised the FDA’s decision to work with lawmakers on LDT reforms. ACLA has vigorously opposed the framework for FDA regulation set out in the draft guidance—even hiring high profile legal counsel and issuing a white paper detailing legal arguments against the agency’s authority to impose the framework.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 their happiness with the delay, as did congressional leaders who had been promoting alternatives to the FDA’s framework. For example, Energy & Commerce Committee Chairman Fred Upton stated it "was the right call" and that imposing regulations "via non-binding guidance documents is not the best approach." He also 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 others were disappointed with the delay. One of those was Andrew Fish, executive director of the medical device industry group AdvaMed Diagnostics, who issued a statement saying that "AdvaMedDx is disappointed that FDA final guidance on LDT oversight is not forthcoming at this time." Echoing the sentiments of Chairman Upton, 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 Aborted
Although welcome, the delay represents a reprieve, not a permanent scrapping of FDA LDT regulation.
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 user fee negotiations slated for 2017, it could take a significant period of time for a revised regulatory approach to emerge, given the new administration’s need to get its new HHS Secretary and other people sworn in. "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 that various stakeholders favor modernization of CLIA in addition to or in place of heightened FDA involvement in LDT oversight, 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."
Takeaway: Labs get at least a temporary reprieve from increased oversight of laboratory-developed tests as the FDA waits for the new administration and further congressional and stakeholder input.