Juelsgaard Intellectual Property and Innovation Clinic students (pictured below) Yale Fu (JD ‘15), Hyosang (Mark) Kim (JD ‘16), and Marta Belcher (JD ‘15) submitted comments to the Food and Drug Administration (FDA) on behalf of three Stanford pharmacogenomics researchers on February 2, 2015. Responding to the FDA’s draft guidance on regulating Laboratory Developed Tests (LDTs), the comments urge FDA to avoid regulation that could stifle innovation in pioneering pharmacogenomics laboratories.
The comments were submitted on behalf of Pharmacogenomics Knowledgebase (PharmGKB) researchers Russ Altman (MD, PhD), Teri Klein (PhD), and Michelle Whirl-Carrillo (PhD). Pharmacogenomics focuses on using individual patients’ genetic data to predict the likely effectiveness and side effects of particular drugs on each patient. This growing field seeks to help physicians make prescription decisions. PharmGKB, managed by Stanford University and funded by the National Institutes of Health, is a publicly available resource that aggregates, curates, integrates, and disseminates knowledge regarding the impact of human genetic variation on drug response.
Historically, the FDA has not exercised regulatory authority over LDTs. Unlike direct-to-consumer genetic tests like 23andMe, LDTs are designed, manufactured, and used within a single laboratory. In June 2014, the FDA issued a draft guidance proposing to regulate LDTs, followed by a request for public comments on the guidance in October 2014. The proposal raised some concerns among pharmacogenomic laboratories and researchers because the proposed regulations could hinder clinical implementation of pharmacogenomic tests, which could be marketed as LDTs.
The comments urge the FDA to minimize regulation on pharmacogenomic tests and avoid overburdening a growing field that promises to improve patients’ health and well being. The FDA’s proposed regulation, with its broad definitions and unclear classification systems, could increase financial risk in the new technological frontier and push investors away from pharmacogenomics. Furthermore, the regulation would conflict with the White House’s recent Precision Medicine Initiative, which has made personalized medicine a national priority with $215 million in proposed research investments.
The comments submitted by the clinic emphasize that the potential burdens are neither justified nor necessary because pharmacogenomics inherently pose little risk to patient welfare. Pharmacogenomic tests differ from diagnostic genomic tests in that they do not diagnose disease risk. Pharmacogenomics-based decisions rely on extensive physician involvement and the field’s own rigorous, self-developed guidelines, which ensure effectiveness and reliability. The comments therefore warn FDA against regulating pharmacogenomics under the same framework as other LDTs.