The FDA and DTC: Time to Set the Record Straight

Earlier this month an FDA advisory panel met for two days to consider a range of issues pertaining to clinical direct-to-consumer (DTC) genetic testing. The non-voting advisory panel’s discussion (pdf), including whether certain genetic tests or categories of tests should be made available only through qualified healthcare professionals, sparked considerable controversy (see here for a collection of links) and confusion.

In response, the FDA agreed to reopen the public docket in order to receive additional public input on scientific issues concerning DTC genetic tests. The docket will reopen tomorrow and will remain open through May 2nd (pdf).

For those with an interest in the FDA’s oversight of DTC genetic testing, this is the first of several opportunities to be heard. In addition to the newly reopened public docket, the FDA has also announced its next “town hall discussion” with top officials from the Center for Devices and Radiological Health (CDRH), the FDA center responsible for the regulation of medical devices, including genetic tests. Both CDRH director Jeffrey Shuren and OIVD Director Alberto Gutierrez are scheduled to participate in a public question-and-answer session on May 5th in Orlando, FL.  An additional town hall discussion is slated for San Francisco, CA later in the year. The Genomics Law Report will post additional details for that meeting as they are made available.