Drugs

WLF Wants Access to PGx Information

Washington Legal Foundation has submitted a comment to FDA supporting the citizen petition of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information. The letter says FDA is running a suppression campaign that not only threatens the public health but also runs afoul of the Constitution.

“By prohibiting clinical labs and software providers from sharing gene-drug testing data with physicians,” it says, “FDA directly infringes on truthful, non-misleading speech. If challenged in federal court, FDA would need to show that it has a compelling government interest in suppressing that speech. FDA cannot possibly meet that burden.”

The WLF comment amplifies its position that:

dissemination of PGx data is constitutionally protected scientific speech;
suppressing the dissemination of PGx data constitutes an impermissible content- and viewpoint-based restriction; and
FDA’s suppression of PGx data cannot survive strict scrutiny under the First Amendment.

“Under the First Amendment,” WLF says, “FDA’s fear that a physician might make an ‘inappropriate’ prescribing decision if she has access to accurate PGx test results cannot justify suppressing that information. PGx test results, which include patient-specific PGx information intended solely for use by physicians treating their patients, constitute core scientific speech entitled to full First Amendment protection. FDA cannot supply the requisite governmental interest in suppressing such speech. And even if it could, it has chosen the most restrictive means available to accomplish its aims. FDA should stop inserting itself between doctors and their patients and abandon its campaign to suppress the dissemination of PGx data.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome