Posted 17 November 2015
By Michael Mezher
The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs).
Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests."
Unlike traditional IVDs, LDTs are developed and used within a single laboratory. According to FDA, these tests historically were "relatively simple tests generally confined to local labs, and often used for rare conditions." However, over time FDA says LDTs have grown more complex and have greater potential to impact patients.
In 2014, FDA announced it would no longer exercise its enforcement discretion on LDTs, saying it would regulate the tests as medical devices, similar to how the agency regulates in vitro diagnostics (IVDs).
The agency spelled out its plans in a draft guidance, Framework for Regulatory Oversight of Laboratory Developed Tests, in which it proposed a risk-based approach to regulating LDTs, based on three risk classes: high-, moderate- and low-risk LDTs.
Kicking off the hearing, Committee Chairman Joseph Pitts (R-PA) said: "I'm far less interested in litigating the boundaries of current FDA or CMS legal authority, than in hearing from our witnesses about how such authority could be clarified or improved."
Ahead of the hearing, the Energy & Commerce Committee released a draft discussion bill that echoes many of the principles contained in FDA's draft guidance, including that "FDA would regulate test development activities in a risk-based manner, and CMS would regulate lab operations."
However, some members argued against FDA increasing its oversight of LDTs. Rep. Michael Burgess (R-TX) said FDA's proposal would "stifle" innovation, saying it is "crucial that we do not slow innovation or create unnecessary regulatory hurdles … requiring premarket review by the FDA will impose new and arguably unnecessary requirements and costs on clinical laboratories, hospitals and doctors."
Other proposals have suggested dividing oversight of LDTs between FDA and CMS based on the type of test. Shuren rejected this approach, saying "such a system is going to lead to inefficiencies. It's going to lead to inconsistent standards treating the same test differently depending upon who makes the test … if we're going to assure that tests work we need one unified system."
Shuren also highlighted the importance of having one agency tasked with reviewing LDTs, saying "when someone makes a test and another lab … makes a similar test we learn from that and sometimes identify … common problems and … feed that back to test developers … if you split it between two different agencies we're going to lose all that learning."
When asked what standard FDA would hold LDTs to, Shuren said the agency "would apply the same standard we apply to in vitro diagnostic tests that are not made by a lab."
Risks Posed by LDTs
Some members questioned whether LDTs really posed enough concern to necessitate greater regulation.
Responding to these concerns, Shuren pointed members to a report issued by FDA on Monday which highlighted 20 cases where LDTs posed a direct risk to patients when they did not meet their performance specifications.
Shuren also said that detecting issues with LDTs is difficult because the agency does not have systems in place to monitor the tests. However, he said that for some already cleared LDTs, their developers "started to identify problems [after] they put in the systems … in place."