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.
Next steps
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.
Authored by Randy J. Prebula, Susan D. Tiedy-Stevenson, Jennifer A. Henderson, and Erkang Ai