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# Petition Seeks to Stop FDA Enforcement on PGx Info
- URL: https://www.fdaweb.com/petition-seeks-to-stop-fda-enforcement-on-pgx-info/
- Published: 2020-01-10T12:00:00.000Z
- Updated: 2026-09-14T15:58:13.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145822

The Coalition to Preserve Access to Pharmacogenomics (PGx) Information has petitioned FDA urging it to stop enforcement actions against genetic tests that claim to predict a patient’s response to specific medications. Over the past year, the agency has warned several companies about claims made for specific genetic tests. It also issued a [safety communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624725.htm?ref=fdaweb.com) cautioning that changing drug treatment based on results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for patients.  

The coalition’s 1/9[ citizen petition](https://www.360dx.com/sites/default/files/citizen%5Fpetition%5F-%5Fcoalition%5Fto%5Fpreserve%5Faccess%5Fto%5Fpgx%5Finformation%5F00615870.pdf?ref=fdaweb.com) says FDA’s efforts to restrict PGx information is “unlawful” and “poses a significant risk to public health by denying physicians access to truthful scientific information that can help them treat their patients. FDA’s approach is also incompatible with the goals and principles of personalized medicine. FDA has publicly espoused the value of personalized medicine generally and PGx in particular. FDA’s repeated attacks on PGx, however, are incompatible with the goal of increased utilization of PGx data in clinical decision-making.”  

The petition also asks FDA to revise the earlier safety communication clarifying that laboratories and software providers may communicate information about gene-drug interactions as part of genetic test reports to the extent such information is supported by adequate evidence and is not contraindicated by information in drug labels with PGx information. Additionally, it asks the agency under First Amendment protections to “permit clinical laboratories to include medication-specific information in PGx test reports that is (**1**) included in FDA-approved drug labels or (**2**) that is supported by adequate evidence of PGx gene-drug associations without clearance or approval of a premarket submission.”