There was a meaningful update from the U.S. Department of Health and Human Services (HHS) yesterday regarding FDA’s regulation of laboratory-developed tests (LDTs). Specifically, HHS reversed its policy change from last year, and gave FDA the ability to regulate LDTs.
- What are LDTs? Generally, LDTs refer to tests that are developed within a single laboratory for use within that laboratory. However, there is no set definition for this term. FDA proposed a relatively narrow definition in a guidance document in 2014, but this has not been finalized. LDTs can be distinguished from medical devices in that medical devices (e.g., in vitro diagnostics) may be developed by multiple parties, and distributed for use outside of a single laboratory. But again, the boundary for what is an LDT can be vague.
- What happened before? Recall that in August 2021, HHS limited FDA’s authority to regulate LDTs, stating that FDA must engage in notice-and-comment rule-making before subjecting LDTs to premarket reviews. Considering that notice-and-comment rule-making takes years to accomplish (if at all), practically speaking, this meant that FDA would not be able to regulate LDTs. It also meant that there would be a potential regulatory vacuum for LDTs other than regulation under CLIA (and in fact, companies took advantage of this). Publications reported then that there were significant disagreements between HHS and FDA over this decision; ultimately, HHS overrode FDA and issued the decision.
- What does this mean? Given the prior history (and other factors) and the new administration, we expected that FDA would try to regain the authority to regulate LDTs. In fact, the fight over whether FDA has the authority to regulate LDTs has been ongoing for decades, and it was clear that this was not one that the agency would give up on easily. And the change finally happened yesterday. The new HHS Secretary – Xavier Becerra – said that it is withdrawing the Trump-era policy that limited FDA’s ability to subject LDTs to premarket reviews. Note that the statement focuses on COVID-19 tests; however, its implications expand beyond just COVID-19 tests.
- What happens now? For now, as with everything LDT, it is unclear what will happen next. My best guess is that rather than immediately wielding this authority, FDA may reserve its newly-regained authority for the most onerous violations (e.g., inaccurate COVID-19 tests with wild claims) and engage in a careful policy making process. Congress may also act to clarify the legal framework for LDTs by enacting new laws (e.g., VALID Act introduced in 2020). Again, it is not clear for now, but generally speaking, this could represent the strengthening of FDA’s authority to regulate LDTs in the coming years.