Congress, FDA cracking down on direct-to-consumer genomics

1 minute read

It’s been a busy week for DNA news. In the DNA arrest database example, Congress seems to have no problem with more testing. In the case of personal genomics companies, Congress seems ready to move toward more government control of the industry – announcing hearings in the wake of FDA inquiries into direct-to-consumer genomics testing.

Most of the best reporting is being done outside the mainstream press, particularly by Dan Vorhaus of Genomics Law Report (“Breaking: Congress to Investigate DTC Genetic Testing”, “FDA Puts the Brakes on Pathway-Walgreens Pairing; Whats Next for DTC?”, “Of Drugstores and Devices: Parsing the FDAs Evolving DTC ‘Policy’”).

Some have expected government action in this area for several years now, so the current moves by Congress and the FDA are not surprising. But it’s not clear why the Pathway Genomics Walgreens announcement set off their alarms. Here’s Vorhaus:

So what is it, exactly, about the Pathway/Walgreens partnership that prompted the FDA to act so quickly and publicly? Would the FDAs response have been different if Pathway had partnered with Wal-Mart? With And if we get all the way to, how different is this from what Pathway was already doing: selling its test directly to consumers through a publicly accessible website?

GenomeWeb also has good coverage of the developing story: “First Walgreens, Now House Calls: The Increasingly Bizarre Predicament of DTC Genetic Testing”. Daniel MacArthur has a summary post listing the developments and providing some commentary: “Where to next for personal genomics?”