genomeboy.com

I can’t help but wonder if these guys are forced to blog about the FDA as some kind of punishment. That said, they are doing a brilliant job so far. Today’s post features an extended riff on the ongoing regulatory kerfuffle surrounding consumer genomics companies. What struck me was how markedly the FDA’s stance has changed from the heady and idyllic days of 2007-2008:

Federal regulators were favorably disposed to the industry at the outset. Before launching their product, 23andMe met with then FDA Commissioner Andrew von Eschenbach, who “encouraged [them] to proceed”. Several more startups were even approached by senior FDA officer Lawrence Lesko to officially collaborate on a study of genetic influences on drug response. Lesko, the Director of FDA’s Office of Clinical Pharmacology, gave a presentation at Temple University where he mentioned 23andMe’s potential to improve “access to genetic testing” and enable a “new, educated generation of health care providers and patients.”