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pharmacogenomics

While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

According to the DOJ, the company also accepted a 25-year ban on participating in any federal healthcare program.

The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."

The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.

The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.

Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.

While the FDA has expressed concerns about PGx testing, CEO Erik Hennings said the company has taken measures to limit the risk of consumer harm.

CPIC wants to issue guidelines for non-actionable genes, standardize PGx terms, and work with groups like ClinGen and ClinVar to expand use of its guidelines.

Organizations including Quest, J&J, Medecision, and the ACCP have formed the Get the Medications Right (GTMRx) Institute to promote PGx testing.

With 10,000 of Mayo's patients now sequenced for 77 genes, a subset of this information is being used to inform care while the bulk of the data is spurring research projects.

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