Feb 5, 2016 - News

The FDA Wants To Hear Your Opinion

If you have an opinion about genetic testing and the best way to return those results, the U.S. Food and Drug Administration (FDA) 23andMe_Logo_blogwants to hear it at a daylong workshop scheduled for March 2nd.how

The meeting offers the FDA a chance to get perspectives from the public and medical professionals on how best to convey genetic test results in a way that meets the needs of both patients and practitioners.

The meeting comes on the heels of the ambitious Precision Medicine Initiative, announced during last year’s State of the Union address. Genetic testing and patient access and engagement are key components of the initiative.

As such the FDA is “considering new approaches in its regulation” of certain types of genetic testing, according to the Federal Register.

What: Patient and Medical Professional Perspectives on the Return of Genetic Test Results

When: March 2, 2016 from 8 a.m. to 4 p.m.

Where: FDA’s White Oak Campus
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503)
Silver Spring, MD 20993

For more information go here.

As part of the run-up to the meeting, the agency has offered up several case studies with different scenarios involving genetic testing. For instance, how to handle reporting on variants associated with different levels of risks for Alzheimer’s disease, or how to report on results that might include conflicting information or that have limited evidence.

The FDA wants to hear opinions on how best health care professionals should handle this kind of information.

You have three ways to participate:

  1. Attend. People who want to attend and give their comments in person must register for the event, which has limited seating. The workshop is scheduled to begin at 8 a.m. ET March 2nd at the FDA’s White Oak Campus in Silver Springs, Maryland.
  2. Watch Webcast. The meeting will also be Webcast. Comments can be sent in the mail addressed to Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, and Rm. 1061, Rockville, MD 20852.
  3. Submit comments online. Comments can also be submitted online by March 31st. All submissions, whether done through the mail or online must include reference to: “Docket No.  FDA-2015-N-4809 for `Patient and Medical Professional Perspectives on the Return of Genetic Test Results; Public Workshop; Request for Comments.’”


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