On July 8, 2020, WLF filed comments with the FDA in support of the Citizen Petition of the Coalition to Preserve Access to Pharmacogenomics (PGx) information. By identifying likely gene-drug interactions, PGx testing allows a physician to make better informed prescribing decisions, which should lead to better health outcomes and lower healthcare costs. The Coalition’s petition thus raises legitimate questions about the FDA’s ongoing campaign to “suppress communications by clinical laboratories and software providers about the role of PGx in the metabolism of, and response to, specific drugs.” WLF’s comments make clear that the FDA’s suppression campaign not only threatens to undermine the public health, it also runs afoul of the Constitution. By prohibiting clinical labs and software providers from sharing accurate gene-drug testing data with physicians, the FDA directly infringes on truthful, non-misleading speech.


WLF’s Comment to FDA on PGx Labs