Bass, Berry & Sims attorney Heather Pearson provided insight on how the recent Supreme Court’s Loper Bright decision overturning the Chevron deference could impact the ways that companies may be able to challenge the U.S. Food and Drug Administration’s (FDA) regulation of laboratory-developed tests (LDTs) as medical devices.
“Under Chevron . . . the FDA would be able to establish a ‘preferred interpretation’ [of an ambiguous statute] and all courts looking at the issue would have to defer to this interpretation,” said Heather. “Arguably, this . . . would allow for consistency across the regulatory landscape. Because Loper ended this deference, it will now be up to each individual judge . . . to assess what Congress actually meant when it passed a particular law.”
Heather noted that while Skidmore deference still exists, it gives far more leeway to courts than Chevron deference in deciding what a statute means. As noted in the article, the Skidmore deference “stems from a 1944 Supreme Court case where the justices concluded that courts could rely on a federal agency’s decisions made in good faith and based on specialized experience ‘to which courts and litigants [could] properly resort for guidance.’” “Unlike Chevron, which required a court to defer to an agency’s interpretation of its own ambiguous statute, Skidmore provides more room for a judge to independently assess the reasons behind an agency’s proposed interpretation,” Heather added.
The full article, “How Could the End of Chevron Impact the FDA and LDTs?” was published in the August 2024 edition of G2 Intelligence’s Lab Industry Advisor and is available online (subscription required).