Science Group Sues FDA Over New Laboratory-Developed Test Rule
Written by: Alistair J. McIntyre & Agnes Juang, Ph.D.
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs).[1] The rule, which became effective on July 5, 2024,[2] explicitly categorizes in vitro LDTs intended for clinical use as medical devices, placing such LDTs within the purview of the FDA.[3] The complaint was filed in the Southern District of Texas. AMP’s suit follows another suit filed by a trade association, the American Clinical Laboratory Association, targeting the same rule.[4]
As we previously discussed, the FDA had historically opted for discretionary non-enforcement of requirements for most LDTs. The recent rule provides for a four-year, five-stage period during which the FDA will phase out this discretionary approach for many LDTs. [5] During this time, the FDA will begin implementing medical device reporting requirements for such LDTs.[6]
The Complaint estimates that, if implemented, the new LDT rule could cost up to $114 billion in one-time expenditures and $14.31 billion in annual recurring costs.[7] The global in vitro diagnostic market is estimated to be about $82.4 billion.[8] In vitro diagnostic development was accelerated during the COVID-19 pandemic, perhaps partly due to a facilitative regulatory environment.[9]
In its complaint, AMP argues that the Food, Drug, and Cosmetic Act (“FDCA”) and Clinical Laboratory Improvement Amendments of 1988 establish congressional intent that LDTs are not under the FDA’s authority.[10] AMP explicitly invokes the “major questions doctrine” in alleging that Congress did not clearly wish to assign to the FDA a question of such economic significance.[11]
AMP, founded in 1995, is a non-profit group focusing on molecular pathology. AMP has over 2,900 members, including individuals from academic and community medical centers, government, and industry.[12]
[1] See Complaint, Association for Molecular Pathology v. FDA, No. 3:24-cv-00241 (S.D. Tex.) (the “Complaint”; available at https://www.amp.org/AMP/assets/File/advocacy/AMPvFDA_Complaint_8.19.2024.pdf).
[2] 21 C.F.R. § 809 (available at https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf).
[3] Id.
[4] See American Clinical Laboratory Association v. FDA, No. 4:24-cv-479 (E.D. Texas) (available at https://www.acla.com/wp-content/uploads/2024/06/ACLA-LDT-Complaint.pdf).
[5] 21 C.F.R. § 809, Docket No. FDA-2023-N-2177 at 26–27.
[6] See id.
[7] See Complaint at 61.
[8] Global IVD Market Size, Share, Trends, COVID-19 Impact and Growth Forecast Report, Market Data Forecast (visited April 30, 2024) (https://www.marketdataforecast.com/market-reports/global-in-vitro-diagnostics-market) (estimate for the global IVD market in 2024).
[9] See Oyewole, Anne et al., COVID-19 Impact on Diagnostic Innovations: Emerging Trends and Implications, Diagnostics 11(2): 182 (January 27, 2021) (https://doi.org/10.3390/diagnostics11020182).
[10] See Complaint at 4.
[11] See Complaint at 59.
[12] See About, AMP.org (visited September 3, 2024) (https://www.amp.org/about/who-we-are/); Complaint at 7.