Health Groups Ask FDA to Withdraw Lab Test Guidance

The AMA and nearly 40 other organizations Nov. 18 sent a letter to the Food and Drug Administration asking it to withdraw draft guidance documents on laboratory developed tests and to instead commence formal notice and comment rulemaking on the matter. In a related move, the American Clinical Laboratory Association, which co-signed the AMA letter, Nov. 18 announced it has retained two attorneys to represent it in opposing the FDA’s LDT draft guidance. The AMA’s letter said “guidance documents do not carry the legal certainty and weight of regulations that provide the regulated [entity] reasonable assurances and ability to comply with the FDA’s requirements.” According to the AMA letter, “Protections afforded by the notice and comment rulemaking process include the requirement that the Agency respond to all stakeholder comments and undertake an economic impact analysis of the new regulatory oversight to assess the estimated burden on the regulated.” Responding to stakeholder comments and conducting an economic impact analysis “are critical exercises to address widely-held concerns with the lack of specificity and clarity in the proposed guidance that undermine the ability of impacted stakeholders to provide constructive and informed feedback on the proposed changes,” the letter said.