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FDA Lab Test Rule May Be Finalized by May 2024 to Avoid Republican Challenge, McMillin Says

December 4, 2023

Bobby McMillin, Managing Director of the firm’s Legislative & Public Policy practice, was recently quoted in the Inside Health Policy article, “LDT Rule Must Be Finalized By May To Avoid Congressional Scrutiny.” The article discusses the U.S. Food and Drug Administration’s (FDA) recent rule that allows the agency to assert greater regulatory oversight over laboratory developed tests (LDTs).

McMillin told Inside Health Policy that the FDA may push to get the rule finalized before May 2024. Any further delay could give Republican critics of the rule the opportunity to unwind it through the Congressional Review Act should they win the presidency and both Houses of Congress in 2024’s elections. “If I were the administration, I would want to make sure any potentially controversial major rules, including LDTs, are finalized by Memorial Day if not earlier,” McMillin said.

Read the full article.