September 11, 2014

FDA Avoiding OMB-Mandated Economic Review of Lab-Developed Test Regulation?

From: GenomeWeb/Pharmacogenomics Reporter

Legislators Question FDA, Stakeholders on How LDT Oversight Impacts Industry, Patients, Innovation

By Turna Ray

NEW YORK (GenomeWeb) – Members of the US Congress today grilled a US Food and Drug Administration official regarding the agency’s legal authority to regulate lab-developed tests (LDTs), asking whether new requirements would trigger additional costs and taxes upon laboratories, and whether the FDA itself had the necessary resources to take on this enormous task.


Need for economic analysis

Noting that oversight of LDTs represents a significant shift in its policies, some legislators pressed FDA about whether it should issue a rule, instead of a guidance, to implement its regulatory plan. In contrast to guidance, in issuing a rule the FDA would need to provide more justification for its policy changes, for example, showing what the economic impact of the proposed regulatory plans would be.


Burgess hinted several times during the hearing that the FDA was issuing guidance in order to avoid an economic impact survey by the Office of Management and Budget. “Are we going with guidance, because [rule-making] actually triggers a response from the OMB as to the financial impact” of the policy changes, Burgess posited. “If the onus is so severe, then why not go through a more … established pathway and let’s do the economic analysis.”

The extent of harm

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