As election results approach and speculation mounts amid concerns that Donald Trump if elected to a second term would once again ax FDA’s oversight of lab-developed tests (LDTs), Public Citizen, joined by five other organizations, submitted an amicus curiae brief Monday (Nov. 4) laying out legal arguments for why FDA should continue to regulate LDTs as medical devices.
The brief was filed in opposition to the American Clinical Laboratory Association’s lawsuit in the U.S. District Court in the Eastern District of Texas challenging the Biden FDA’s move to reinstate oversight of LDTs.
The major consumer advocacy group’s amicus brief backs FDA’s LDT rule, arguing that a successful challenge by the plaintiffs could jeopardize patient safety by undermining the reliability of tests critical for diagnosing and treating cancer and other medical conditions.
“And because laboratory developed tests play an increasingly critical role in the diagnosis and treatment of disease, FDA regulation is needed to ensure that devices manufactured by laboratories are safe and effective, just as devices manufactured by other entities must be,” Public Citizen says in a Monday press release on its brief.
Joining Public Citizen in the brief are the American Cancer Society Cancer Action Network, American Society of Clinical Oncology, Friends of Cancer Research, National Brain Tumor Society, and Ovarian Cancer Research Alliance.
“Interpreting the term ‘device’ in the FDCA to exclude laboratory developed tests, as the plaintiffs here urge, would undermine the framework that Congress created for assuring patient safety,” the amicus brief says. “The Court should reject that reading and uphold the FDA’s rule as the best interpretation of the plain language of the statutory definition.”
GOP presidential candidate Donald Trump axed FDA’s oversight of the tests when he was previously president, and the ranking Republican on the Senate health committee has alleged FDA’s regulatory bid to reassert its jurisdiction is illegal.
In the brief, Public Citizen cites a recent report that predicts that the international market for LDTs will grow at an annual rate exceeding 7% from 2024 to 2030, with the U.S. market experiencing the fastest growth during this period.
Public Citizen says many of these tests are produced by laboratory corporations that accept patient specimens nationwide and process large volumes in single facilities.
With laboratories handling vast numbers of samples, even one inaccurate test can impact thousands of lives, the consumer rights group says.
Considering these factors, FDA concluded that the risks associated with most LDTs are significantly higher now than when it began implementing the Medical Device Regulation Act in 1976, noting that many of these tests resemble other in vitro diagnostic products not previously subject to its enforcement discretion.
Public Citizen argues that as the medical profession increasingly depends on sophisticated LDTs, FDA’s previous hands-off approach no longer aligns with the Food, Drug and Cosmetic Act (FCCA) mandate to ensure medical devices are safe and effective.
The tests are critical for high-stakes medical decisions, and inaccurate results can lead to severe consequences, including the spread of disease, missed or misdiagnoses, ineffective treatments with harmful side effects, and the omission of life-saving therapies, the Public Citizen brief says. The Centers for Disease Control and Prevention estimates that preventable diagnostic errors result in 40,000 to 80,000 deaths each year.
The brief cites that the New York Department of Health’s Clinical Laboratory Evaluation Program provided insights from its experience regulating LDTs, revealing that over half of the tests submitted could not be approved based on the initial applications.
Additionally, around 10% of tests not initially approved required four or more review rounds. Reasons for non-approval included design flaws, insufficient validation data, and process issues that raised concerns about result reliability, according to the brief.
“In light of the foregoing and other record evidence, the FDA had ample justification to end its enforcement discretion and regulate laboratory developed tests as “devices” under the FDCA,” the amicus brief says.
In January, CMS and FDA published a joint statement backing the LDT rule and stating their respective authority over diagnostic tests is complementary and that FDA is in the right position to regulate LDTs. Similarly, in the amicus brief Public Citizen says, “CMS does not and cannot fill the FDA’s role in this area.”
FDA finalized the LDT rule in April with some concessions to the barrage of negative feedback it received from industry stakeholders, including adding more categories of tests that will continue to receive enforcement discretion. While FDA says the exemptions are necessary to avoid discouraging companies from producing LDTs and ensure patient access to critical tests, a legal expert told Inside Health Policy that the real reason could be to prevent FDA from running out of resources to enforce its new requirements.
A health care expert speculated in September that Congress may slip a provision into an expected lame-duck health package to block FDA from moving forward with its LDT rule. FDA is already facing two lawsuits on the rule that could offer a first glimpse of post-Chevron arguments concerning FDA authority. — Maaisha Osman (mosman@iwpnews.com)
https://insidehealthpolicy.com/daily-news/public-citizen-lays-out-legal-arguments-fda-keeping-ldt-role
