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.
Dan, do you think Shuren will address the video controversy? It is unusual for a video on a technical FDA topic to garner 4000 views. It is also on the first page of search results for his name.
http://www.youtube.com/watch?v=YI-m2Cucdoo
The FDA must have been taken aback by the strength of resistance to their proposed restrictions. They are also in trouble as the Republicans have specifically targeted them for budget cuts after hearing about how their activity last year directly cost Pathway Genomics the ability to create 100 jobs.
http://blog.pathway.com/pathway-genomics-participates-in-round-table-discussion-with-top-congressional-leaders/
Joshua Sharfstein stepped down in January rather than become a pinata for the House. What do you think of Jeffrey Shuren’s future at the agency?
I believe in personal responsibility and extremely minimal government involvement in things that can very easily be run and maintained by personal interest.
I want the FDA to only regulate that the data is accurate and to be able to punish false advertisers. Leave the government regulations out of our bodies and let us decide what’s best for own needs.