USA – Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

Law firm Hyman, Phelps & McNamara (HP&M) last week filed a citizen petition on behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information, requesting that the US Food and Drug Administration (FDA) allow laboratories to provide gene-drug interaction information in genetic test reports.

Background

The petition comes after FDA in 2018 and 2019 took action to crack down on unapproved genetic tests that offered gene-drug interaction information either directly to consumers or to patients via their physicians. In 2018, FDA issued a safety communication and statement advising that “clinical evidence is not currently available for these genetic tests or software programs and, therefore, these claims are not supported for most medications.”
 
Then, in April 2019, the agency warned Virginia-based Inova Genomics Laboratory over its MediMap tests for predicting medication response after the company declined to remove claims regarding drug response information from labeling and promotional materials. The company had previously argued that its tests are laboratory developed tests (LDTs) and are not subject to premarket review or labeling requirements…