Regardless of your politics or mine, on January 20th a new administration will assume leadership of our country. A few months ago, if you told me I would be hearing “The Cubs won the World Series” and “Donald J. Trump will be our next President,” I would have thought the likelihood of either or both happening would be unlikely. It has been quite seachange of events since November. Although too early to think about the next election process, I am predicting the Cubs to win the World Series in 2017.
Under this new administration in Washington, we might expect that the Food and Drug Administration (FDA) will likely not pursue regulating laboratory developed tests (LDTs). While the FDA has long held this power within its purview, it has not exercised it for many years. For laboratories across the country, discussion of the FDA regulating LDTs, and what it would mean in terms of compliance, has long been a topic of interest. Historically, laboratories have relied upon the Center for Medicare and Medicaid Service (CMS), under the Clinical Laboratory Improvements Amendment (CLIA), to conduct reviews and inspections to ensure safe testing.
In 2014, the FDA published a draft rule outlining a framework through which the agency could expand its jurisdiction over molecular tests to also include LDTs. Digital pathology has also been mentioned in public forums as potentially falling into these frameworks.
In 2015, the FDA issued a report citing 20 examples where LDTs may have caused patient harm.
Initially these tests were simple and scarce, and the agency did not see a reason to intervene. But over the past decade, these tests have become more numerous, more complex and heavily marketed. As a result, the FDA started down this road.
In recent weeks, the FDA has backed off from a plan to issue final guidance for the regulation of LDTs.
Republicans in Congress, who believe such oversight unnecessary, applauded the decision. Patient advocates and research groups, concerned about the validity and accuracy of such tests, are hopeful a new administration will take up their cause.
Cost estimates of subjecting a single academic medical center-developed test for FDA approval have been reported to cost as much as tens of millions of dollars, potentially limiting laboratories to develop new tests for patients for everything from prenatal assays to cancer diagnostics.
There is no official statement from the FDA on the potential timing of any new guidance.
No doubt this is a challenging area in the era of personalized and predictive medicine – with high potential and equally high risks.
With the incoming President and Republican congress, the FDA is unlikely to play a role in this space. Laboratories will continue to self-validate and self-regulate LDTs without direct FDA oversight under the current auspices of CLIA.
Time will tell, but perhaps LDTs will be an area ripe for development, validation, testing and commercialization. New tests will be brought to market with less cost and less oversight.
Time will tell. Pitchers and catchers report in a few months. The Cubs may win the World Series again before this debate gets sorted out as to what is in the best-shared interests of innovation and safe patient care.