FDA grants 23andMe clearance to offer interpretive drug information
The US Food and Drug Administration (FDA) granted 23andMe a 510(k) clearance that allows the company to offer a pharmacogenetics report on two medications: clopidogrel (prescribed for certain heart conditions) and citalopram (a depression medication). With the new clearance, 23andMe can provide interpretive drug information to customers for two medications without a confirmatory testing. 23andMe Chief Legal and Regulatory Officer Kathy Hibbs said that the clearance is a testament to the clinical validity of 23andMe results. In the decision, the FDA stated that the 23andMe pharmacogenetic report is a safe and effective consumer product that can support customers with certain genotypes to understand how their body may respond to certain medications and encourage conversations with their healthcare provider.