James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in 360Dx, in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom,” by Adam Bonislawski. (Read the full version – subscription required.)

Following is an excerpt:

The US Food and Drug Administration appears determined to move quickly on its proposed rule covering regulation of laboratory-developed tests (LDTs).

The agency has rebuffed calls from various stakeholders to extend its public comment period, prompting some observers to suggest it is hurrying to get the rule on the books both to prevent it from being undone by a change in administration and to keep its implementation aligned with the next renewal of the Medical Device User Fee Amendments in 2027. …

James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C., said that it is "certainly possible that there will be challenges that weave in the expediency as an explanation for why any final rule should be invalidated."

Boiani suggested that such an argument around expedience would more likely come into play in disputes around particular details of the rule as opposed to the broader question of whether the FDA has the authority to regulate LDTs under the medical device framework it uses for in vitro diagnostics, which, he noted, has been thoroughly discussed over the last several decades.

"FDA can point to years and years of statements, advisories, warning letters, etc., that have consistently asserted that fundamental position," Boiani said.

As for why the agency is moving quickly on LDT rulemaking despite stakeholder requests for more time, Boiani said he thinks the looming 2024 elections are "undoubtedly" a driver. He noted that the election of President Donald Trump in 2016 effectively ended the FDA's efforts to regulate LDTs by guidance, and that given this history, the agency "will want to get this in the [Code of Federal Regulations] before November of next year."

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