James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Genome Web, in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation,” by Adam Bonislawski.

Following is an excerpt:

Following the failure to legislatively clarify who gets to regulate laboratory-developed tests and after months of anticipation, the US Food and Drug Administration on Friday issued a proposed rule for the oversight of laboratory-developed tests that will surely meet resistance from all corners of the clinical lab and diagnostics markets.

The rule would amend FDA regulations to make explicit that LDTs are in vitro diagnostics (IVDs) and that all IVDs are medical devices and therefore overseen by FDA under the Federal Food, Drug, and Cosmetic Act (FDCA).

Additionally, FDA said it is changing agency policy to phase out what it described as an "enforcement discretion approach" to LDTs and to provide greater oversight of these tests, though the rule indicates the possibility of carve-outs for several categories of test, including manual tests designed and performed in a single laboratory; tests currently marketed as LDTs; and LDTs offered by academic medical centers.

FDA has for more than three decades maintained that LDTs are medical devices that fall under its authority according to the FDCA, an assertion it once again made in the new proposed rule. The agency has by and large refrained from exerting this supposed authority, though, adopting what it has called a policy of enforcement discretion.

In recent years, however, FDA has argued — including in the new proposed rule — that its policy of enforcement discretion is no longer appropriate given the increasing complexity of LDTs and their ubiquity throughout the healthcare system, including for the diagnoses and management of life-threatening conditions. It has also noted that a number of vendors offer their tests as LDTs as a way of avoiding FDA regulation, even though these tests are marketed to large and diverse customer bases much like traditional IVDs.

In 2014, the agency released a pair of draft guidances in which it said it would require registration of LDTs and premarket approval of certain higher-risk LDTs. The agency received substantial pushback from the clinical lab and diagnostics industries, which questioned its authority over the tests, and two years later, following the election of President Donald Trump, the agency halted its LDT regulation plans.

More recently, much of the action around LDT regulation shifted to Congress, where lawmakers worked to craft legislation — most notably the Verifying Accurate Leading-edge IVCT Development (VALID) Act — that would have given the FDA authority over LDTs. However, in the aftermath of Congress's failed attempts to pass such legislation, FDA announced that it would resume its own efforts to regulate LDTs.

James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C, said that compared to previous stabs at LDT regulation like VALID and the 2014 draft guidances, the proposed rule is "basically the strongest approach possible."

The rule "is much more black and white and simpler," he said. "Before, their strategy had been sort of preemptively nuanced with lots of exceptions and longer phase-in times and all of that."

Potential exceptions …

FDA also requested that commentors address the question of whether the agency should maintain enforcement discretion for LDTs that have undergone evaluation by certain third-party reviewers such at the New York State Department of Health.

Boiani said, however, that he doesn't see these provisions as indications of flexibility on the agency's part.

"I didn't parse that as [FDA] saying it is going to offer flexibility or allow for a lot of exemptions," he said. …

Legal fight looming

Whether or not the notion of potential exemptions assuages the concerns of some opponents of LDT regulation, the proposed rule will likely face legal challenges. Boiani said that in the proposed rule FDA made one of its more thorough arguments to date that it can legally regulate LDTs, but its authority to oversee these tests remains unclear and turns on a number of legal issues.

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