Bloomberg Law Quotes Nathan Brown on FDA and Clinical Diagnostics

Akin Gump health care and life sciences partner Nathan Brown was quoted by Bloomberg Law for its article “FDA Action on Clinical Diagnostics Poised to Gain Steam in 2023.” The article discusses the likelihood that the Food and Drug Administration (FDA) will restart its efforts to oversee diagnostic tests from laboratories after Congress neglected to act on legislation that would require FDA to regulate them.

On the topic of FDA using existing regulations to develop a concept close to that of the neglected legislation, Brown, who served both at FDA and on the Senate Health, Education, Labor and Pensions Committee, said that a rulemaking exercise might include addressing the criteria for what constitutes a laboratory-developed test, or LDT.

He gave as an example the agency possibly outlining, through rulemaking, the circumstances under which an LDT would need to go through the premarket review process.

Brown noted that FDA is also likely to see if could begin to take actions against certain LDTs that raise concerns about performance or safety, adding, “Depending on the details, taking action in the absence of rulemaking may also engender pushback or even legal challenges.”