by: Erica N. White, J.D.; Jennifer L. Piatt, J.D.

The 2023-24 U.S. Supreme Court term contains multiple cases with significant nation-wide impacts on public health, including FDA powers to regulate specific medications, supremacy of federal emergency health care laws, and judicial deference to administrative agency interpretations generally. Previously, in its 2022-23 term, the Court drastically changed the public health landscape nationally, issuing far-reaching opinions limiting civil rights initiatives, expanding First Amendment protections, strictly controlling the reach of federal administrative agencies, and generally protecting commercial or industry interests over clear threats to the public’s health. 

The Center for Public Health Law & Policy at ASU’s Sandra Day O’Connor College of Law, in its second annual assessment, identified the 2022-23 term’s “top 10” Supreme Court public health-related actions. 

Several cases impacted civil rights. In companion cases brought against Harvard University and the University of North Carolina-Chapel Hill, the Court overruled decades-old affirmative action precedent. Projected limitations on race considerations in public and private allocations extend past the education sector. However, the Court rejected Alabama’s attempts to racially gerrymander its voting districts based on likely Voting Rights Act violations, leaving the law in place. However, the Court rejected notions that treaties with the Navajo Nation implicated affirmative federal duties to defend the Tribe’s water rights, even as the Colorado River is historically depleted.

The Court remains hesitant to apply existing statutory laws to the internet. Despite the platforms’ use by known terrorists, the Court declined to extend liabilities to internet platforms Google and Twitter for mere use of the websites. Similarly, the Court found that individuals making threatening social media messages could not be found criminally liable without a heightened “true threat” showing. The Court continued its expansion of First Amendment protections by favoring a Colorado website developer’s discrimination against customers based on their sexual orientation or gender identity. 

The Court continued its hostile treatment of administrative authorities while upholding strong executive authorities over immigration. The Court struck down the Biden-Harris Administration’s student loan forgiveness plan in August 2023 as too politically and economically significant for agencies to regulate absent specific legislation, exceeding the Department of Education’s statutory authority. However, the Court declined to extend standing to Texas and Louisiana in challenges to the Biden-Harris Administration’s immigration policies, finding no ability for states to contest executive immigration prosecutorial authorities. And, the Court upheld private actions pursuant to a federal nursing home reform statute, finding “unambiguous” individual recovery rights in the law. 

“Shadow docket” Court action during the 2022-23 term was also significant. In April 2023, the Court stayed a Texas federal court decision condemning mifepristone, part of the two-drug “abortion pill” regime, as unconstitutionally approved by FDA. The Court will undoubtedly assess this case more fully during the upcoming term, and its decision may impact not only abortifacients, but the FDA’s overall scheme to approve safe and effective drugs for circulation in interstate commerce.

Following the conclusion of the Court’s 2023-24 term in late June 2024, public health legal scholars will re-visit the term, providing analysis and predictions of the impacts going into the following 2024-25 term.

By: Max Mashal, Juris Doctor Candidate (Class of 2025), Sandra Day O’Connor College of Law at Arizona State University

Introduction

On September 29, 2023, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would classify laboratory-developed tests (LDTs) as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA) by amending the definition of in vitro diagnostic products (IVDs) under 21 C.F.R. § 809.3(a).[1] If this rule is implemented, LDTs will now have to meet the same regulatory standards as other FDA-regulated medical devices.[2]

Laboratory-Developed Tests

Laboratory-developed tests are in vitro diagnostic products that are designed, manufactured, and used within a single clinical laboratory which meets certain laboratory requirements (including CLIA certification).[3] Until recently, LDTs were mainly used for rare diseases and low-volume testing.[4] Now, they are widely-used by a more diverse population, thanks to high-tech instrumentation and software.[5] LDTs can now be used to diagnose and treat complex diseases, act as companion diagnostics for personalized medicine, and can be rapidly adapted to address emergency responses.[6]

However, unlike other IVDs, LDTs have not historically been subject to the FDA’s regulatory oversight.[7] The FDA has exercised enforcement discretion over LDTs for decades, allowing them to enter the market without FDA approval or clearance.[8] This has created a regulatory gap that poses significant risks to public health, as some LDTs may be inaccurate, unsafe, or ineffective.[9]

Phasing Out the FDA’s Enforcement Discretion Policy

Under the proposed rule, the FDA would implement a phased approach to end its enforcement discretion policy over a period of one to four years after the publication of the final rule.[10] The transition period would vary depending on the risk level of the LDTs, with high-risk tests being subject to premarket review earlier than moderate-risk or low-risk tests.[11] The FDA estimates that about 50% of the current LDTs are low-risk tests that may be exempt from premarket review under the new regulations.[12]

Under the proposed rule, the FDA has structured the phaseout policy as follows:

• One Year After Publication: The FDA’s general enforcement discretion approach would end with respect to Medical Device Reporting (MDR) requirements, as well as correction and removal reporting requirements.
• Two Years After Publication: Enforcement discretion would also end for other requirements. This would exclude MDR, correction and removal reporting, Quality System (QS) regulations, and premarket review. LDTs will then need to comply with FDA regulations related to registration, listing, labeling, and investigational device exemptions.
• Three Years After Publication: Enforcement discretion would end for QS requirements.
• Three and a Half Years After Publication:[13] Enforcement discretion would end for premarket review requirements for high-risk IVDs, subjecting Class III LDTs to full Pre-Market Approval requirements under the FDCA.
• Four Years After Publication:[14] Enforcement discretion would end with respect to premarket review requirements for moderate and low risk IVDs needing premarket review. Class II and certain Class I LDTs would need to meet full 510(k) premarket and de novo requirements under the FDCA. The proposed rule suggests the FDA will not enforce actions against LDTs for which 510(k)s and de novo applications are submitted within this four-year period until the FDA review concludes.

Closing the Theranos Loophole

The FDA’s proposed rule aims to ensure the safety and effectiveness of LDTs, foster innovation, and align with evolving healthcare needs. It also intends to close a loophole which has been exploited by companies like Theranos, a startup that claimed to offer revolutionary blood tests that could perform hundreds of analyses with a single drop of blood.[15] Theranos’ tests were found to be unreliable, inaccurate, and fraudulent, putting patients at risk of misdiagnosis and mistreatment.[16] The company was able to market its tests without FDA approval by exploiting this regulatory loophole for LDTs.[17] The FDA’s proposed rule is intended to prevent such cases from happening again by requiring all LDTs to comply with the same regulatory standards as other medical devices.[18]

Conclusion

The FDA’s proposed rule is expected to face challenges and legal disputes from stakeholders who may oppose the agency’s authority over LDTs or fear the impact of the proposed regulations on their businesses.[19] The public comment period for the proposed rule closed on December 04, 2023.[20]

[1] Medical Devices; Laboratory Developed Tests, Federal Register (2023), https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests (last visited Oct 11, 2023).

[2] Harsh Parikh et al., FDA proposes new regulations to increase oversight of Laboratory Developed Tests, Nixon Peabody LLP, https://www.nixonpeabody.com/insights/alerts/2023/10/11/fda-proposes-new-regulations-to-increase-oversight-of-laboratory-developed-tests (last visited Dec 18, 2023).

[3] Center for Devices and Radiological Health, Laboratory Developed Tests, FDA (2023), https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests (last visited Oct 11, 2023).

[4] Office of the Commissioner, FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests, FDA (2023), https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests (last visited Oct 11, 2023).

[5] Federal Register, supra note 1, at 3.

[6] An introduction to diagnostic testing in laboratories—US, https://www.thermofisher.com/us/en/home/clinical/clinical-genomics/molecular-diagnostics/diagnostic-testing-laboratories-intro.html (last visited Dec 18, 2023).

[7] Federal Register, supra note 1, at 3.

[8] Office of the Commissioner, supra note 4.

[9] Id.

[10] Federal Register, supra note 1, at 19.

[11] Id.

[12] Id. at 8; See also Inside FDA’s Proposed Rule to Regulate LDTs, https://www.thefdagroup.com/blog/fda-proposed-rule-ldt (last visited Dec 18, 2023).

[13] But no earlier than October 1, 2027.

[14] But no earlier than April 1, 2028.

[15] Kezia Parkins, The Theranos saga: a wake-up call for the lab-developed test market, (2022), https://www.medicaldevice-network.com/features/theranos-ldt-regulation/ (last visited Oct 11, 2023).

[16] Id.

[17] Id.

[18] See Office of the Commissioner, supra note 4.

[19] Gregory Levine, Joshua Oyster & Michael Purcell, Regulation Without Legislation: FDA Proposes Rule to Regulate Laboratory Developed Tests and End Historical Enforcement Discretion Policy | Insights | Ropes & Gray LLP, (2023), https://www.ropesgray.com/en/insights/alerts/2023/10/regulation-without-legislation-fda-proposes-rule-to-regulate-laboratory-developed-tests (last visited Oct 11, 2023).

[20] Federal Register, supra note 1, at 2; Center for Devices and Radiological Health, supra note 4.