FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) to provide the agency's view of the current science in pharmacogenetics. A patient's genetic makeup can play an important role in predicting how a person will respond to specific medications. Pharmacogenetic testing promises to aid clinicians in selecting or dosing some medications for certain individuals, but the U.S. Food and Drug Administration (FDA) has expressed concern that claims for the results of these tests have not been supported by sufficient scientific evidence. The collaboration is intended to assure that claims made about genetic test results used to tailor individual therapies are based on sound science.
On February 20, 2020, FDA announced the initiative, described as a "Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications," to address the agency's ongoing concern with certain genetic test companies' and laboratories' claims of clinically relevant associations between test results and individual patient responses to medications.
In the recent past, FDA has expressed concerns about insufficient scientific support for using pharmacogenetic tests to inform prescribing. In 2018, the agency issued a safety communication warning consumers about "direct-to-consumer" firms offering genetic tests with claims unsupported by FDA-approved labeling or other scientific evidence about the use of the results to manage medication treatment.
As part of the Collaborative Review initiative, FDA has created a new web-based resource that includes a table of pharmacogenetic associations for which the data support therapeutic management recommendations. The agency opened a docket for public comment and invites stakeholders to provide feedback on pharmacogenetics associations that should or should not be included in the table.
In the announcement of the Collaborative Review initiative, FDA made clear its ongoing safety concerns and interest in regulating laboratory developed tests (LDTs), stating,
The FDA is committed to continuing to work with Congress on a broader legislative solution to the oversight of in vitro clinical tests generally (including LDTs), which would modernize our regulation of these tests. In the meantime, the FDA should not and cannot stand idly by when safety issues arise.
Companies and laboratories marketing pharmacogenetics tests need to be careful about any promotional claims or scientific communications that may go beyond consistency with FDA-approved labeling.
We will continue to track FDA's regulatory activities concerning these types of genetic tests and LDTs. Please contact us if you need assistance with submissions to the docket, review of claims, or any related negotiations with the agency to assure that marketed products are in compliance.
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