VANCOUVER, British Columbia — At the Association for Molecular Pathology annual meeting here this week, leadership briefed members on what to expect as the association's lawsuit challenging the US Food and Drug Administration's final rule on laboratory-developed test regulation unfolds.
While both the assembled panel and attendees appeared to be in lockstep regarding the lawsuit's justification, uncertainty swirled around how laboratory professionals should prepare as new regulations begin to take effect in the early spring of next year.
"We're in limbo right now, as many of you are," AMP CEO Laurie Menser said. "There's a lot of room with how [the rule] is written that really hasn't been defined. Right now, our focus is, one, on the lawsuit, two, the alternative strategies to defeat the final rule, and three, helping our members prepare for this to be implemented."
The challenge on that front, Menser added, is that "it's unclear to [AMP] what resources you're going to need to meet the FDA requirements. There's going to be this giant gap that we can't provide for you, and that info you're going to have to get from FDA."
Karen Kaul, a past president of AMP and chair of the Department of Pathology and Laboratory Medicine at NorthShore Hospitals in Illinois, who has filed supporting materials in the AMP lawsuit, called the FDA rule "an existential threat to laboratory medicine" that will "radically change" the field and do "a tremendous amount of damage to the way medicine is practiced in this country."
In addition, AMP has calculated that the harm of the final rule to laboratory professionals, patients, and the economy in general would be significant, totaling approximately $113.9 billion in one-time compliance costs and up to $14.3 billion in annual recurring costs. AMP also claims the rule will have a significant negative impact on innovation, patient access, and supply chains.
Hence, AMP's decision to file a lawsuit was not taken lightly, Menser noted. "It's not an insubstantial amount of money to sue the federal government," she said, but added that "there's no use sitting on your rainy-day fund when it's about to pour."
AMP, along with Texas-based pathologist Michael Laposata, filed its lawsuit against the FDA on Aug. 19, looking to overturn the agency's final rule on LDTs, made public on May 6 of this year, which essentially asserts that these tests are in vitro diagnostic products subject to the FDA's oversight.
It is the second lawsuit to challenge the FDA rule, after the American Clinical Laboratory Association (ACLA) and its member company HealthTrackRx sued the agency in May.
According to attorney Roger Klein, a faculty fellow at the Center for Law, Science, and Innovation at Arizona State University Law School and an ex officio member of the AMP Professional Relations Committee, the core legal issues of the two lawsuits are quite similar — first and foremost, whether the Federal Food, Drug, and Cosmetic Act that gives the FDA authority to oversee the safety of drugs, medical devices, and cosmetics also applies to laboratories that assert that they are providing a service as opposed to marketing diagnostic products.
In addition, both lawsuits are challenging whether the FDA has jurisdiction at all over LDTs. The agency asserts that it does, saying that for more than three decades, it has been practicing enforcement discretion until the complexity and frequency of LDTs recently reached a tipping point requiring greater oversight.
On May 6, 2025, the FDA's enforcement discretion "phaseout process" is set to begin, taking place in five stages over the next four years. At its conclusion, the agency will expect that all laboratory-made IVD test systems comply with all applicable FDCA and regulatory requirements unless they fall within a "targeted enforcement discretion policy."
"This is law, so you should be preparing," said Eric Konnick, chair of AMP's Professional Relations Committee and an associate professor at the University of Washington.
He noted that laboratories are going to have to begin making decisions about various software systems and launch them well before May 6 in order to comply with the first stage of the phaseout. This stage requires labs to report certain device-related adverse events and product problems to the agency, report any correction or removal of a medical device if it was initiated to reduce a health risk posed by the device, and have a quality system in place to receive, review, and evaluate complaints.
Lingering questions
In a lively Q&A session following the panelists' presentations, attendees raised questions regarding both the lawsuit and what labs need to do to prepare for the implementation of the new rule, assuming it moves ahead as planned.
One major point of discussion regarded organizations that have come out in support of either AMP/ACLA or the FDA since the suits have been filed. In October, the Association for Diagnostics & Laboratory Medicine, the National Independent Laboratory Association, the American Association of Bioanalysts, the American Society for Clinical Pathology, the American Society for Microbiology, and the Infectious Disease Society of America filed an amicus brief supporting the challenge to the FDA rule.
In addition, earlier this month, six organizations represented by and including Public Citizen filed amicus briefs supporting the FDA's decision. Most notably, this included the American Society of Clinical Oncology, along with the American Cancer Society Cancer Action Network, Friends of Cancer Research, the National Brain Tumor Society, and the Ovarian Cancer Research Alliance.
Although this wasn't a complete surprise, as most of these organizations expressed support for the FDA rule when it was introduced, one attendee noted that it was "quite unbelievable" that various patient groups and especially ASCO have come out in favor of the FDA rule and asked the panelists if there is any way that AMP could try to influence these organizations in the other direction.
Kaul noted that regular conversations with oncologists on her healthcare team have revealed that many of them are thankful for what Kaul's lab does on a daily basis, and a significant portion of them are "totally ignorant as to what's going on" with the FDA rule. She noted that the lab industry's communications about this do not seem to be reaching practicing oncologists, and as such, there is a "big disconnect."
Klein agreed that the difference between what type of testing laboratories are doing and what companies are doing with FDA-regulated in vitro diagnostics needs to be better explained, and several other attendees chimed in that communication and data demonstrating the safety and importance of LDTs are two major areas where the lab industry has fallen short.
Meanwhile, another attendee from a large, national reference laboratory wondered who will decide if a test modification needs to be submitted to the FDA and whether that decision should be made internally and with FDA guidance.
Konnick noted that this is ambiguous right now, and that the FDA has said it will provide additional guidance for all of this over the next year.
"This really speaks to the impracticability of the new rule," Klein said. "[FDA members] have definitely set themselves up for a very challenging task to try and undertake."
Another audience member from a molecular biology reagents and research tools manufacturer wondered what companies like his can do to help the situation.
Konnick noted that as the rule progresses, it would be helpful if manufacturers of RUO reagent kits that are clearly intended for use in LDTs could begin looking into clearing these through the FDA as medical devices moving forward. "Over the years, there have been many things that look like IVDs but are RUO, and that has gotten the agency's attention," he said.