Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Mr. Gutierrez,
I’ve recently learned that the FDA has determined the
genetic test kit from 23andMe are “intended for use in the diagnosis…” as per
21 U.S.C. 321(h). Does the FDA truly
think the public will take a $99 test and use it as the sole basis for
self-diagnoses?
“… if the BRCA-related risk assessment for breast or ovarian
cancer reports a false positive, it could lead a patient to undergo
prophylactic surgery…”
It seems your office believes women wouldn’t consult their
physician when alerted by this test and or physicians wouldn’t seek
confirmation before prophylactic surgery. Are you kidding? I’ve read your recent
letter to 23andMe and your argument is flawed and goes against the mission of
the FDA:
“… responsible for advancing the public health by helping to
speed innovations that make medicines more effective, safer, and more
affordable and by helping the public get the accurate, science-based
information they need to use medicines and foods to maintain and improve their
health.”
Regardless of spin you are essentially banning affordable
genetic screening. Your actions have
consequences and history will be your judge.
I spent four hundred dollars to get my family tested. Had that cost been just 50% more I wouldn’t
have done it. Requiring premarket
approval for genetic screening will further destroy this fledgling
industry and is NOT aligned with the rapidly changing technology of this field.
Your letter states that you have conducted 14 face-to-face
and teleconference meetings, sent hundreds of emails, and dozens of
letters. Which begs the question - was
23andMe at those meetings and responding to your emails and letters? Clearly 23andMe isn’t trying to avoid the
FDA and their use of CLIA certified labs indicates they have taken steps to
comply with FDA guidelines.
While false positives have consequences that I’ve personally
witnessed the net benefit of mass screenings is too great to ignore and I
couldn’t imagine a more effective way to rapidly determine accuracy than to let
the testing proceed with a strong “Surgeon General’s” like warning that the
results are preliminary.
Sincerely,
Dave
