Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, was quoted in an article titled "23andMe Gets a $1.4M NIH Grant, Still Awaits FDA Approval."
Following is an excerpt:
Late last year the FDA barred 23andMe from dispensing health information products to consumers based on analysis of their DNA.
23andMe's latest Washington win comes in the form of a new grant from the National Institutes of Health (NIH). The company will use the $1.4 million grant to access the whole human DNA sequence and discover rare variants associated with various types of diseases. Some of it will improve and expand the online survey tools 23andMe uses to gather health and ancestry information from users.
But Epstein Becker Green attorney Brad Thompson warns that the NIH's decision to make the grant says nothing about 23andMe's progress with the FDA. Thompson helps medical device makers and others work with the FDA on compliance issues.
"People tend to lump the federal government altogether and act as though they share one brain, when quite the opposite is true," Thompson says in an email to VentureBeat. "It is a common everyday occurrence that one federal agency might invest in a new technology that another federal agency views with skepticism. So the NIH investment means nothing with regard to FDA."
