23andMe’s Anne Wojcicki Says FDA Order Seriously ‘Slowed Up’ Gene Test Sales

The U.S. Food and Drug Administration (FDA) has

succeeded in stifling sales for innovative genetic testing company
23andMe. “It has slowed up the number of people signing up,”
23andMe co-founder Anne Wojcicki said during a speech at
music/tech/everything festival South by Southwest (SXSW) on
Sunday.

In late 2013,
the FDA sent 23andMe
a letter ordering it to “immediately discontinue
marketing” of its home genetic tests or face “seizure, injunction,
and civil money penalties.”

The
public largely supports direct-to-consumer sales of gene screening
tests, which for as little as $99 can reveal information such
as ancestry and the presence of hereditary diseases and conditions.
But the FDA worried that consumers may make unwise medical
decisions based on their results. The FDA wants to stop consumers
from accessing important health information for their own good,
see?

Meanwhile, in foreign countries, scholars and government
agencies are going ahead and partnering with 23andMe to continue
moving medicine into the 21st century. At the SXSW
panel, Wojcicki said 23andMe now has 650,000 people in its
database and is “being inundated with requests from academics and
foreign partners.”

Genetics is going to become extremely cheap and part of our
daily life, she said. In China, the Beijing Genome Institute is now
the largest genome testing firm in the world, and Saudi Arabia, the
UK and others are all strong in this area.

Wojcicki also talked about how genetic screening can be used to
reduce health care costs and shift focus from disease treatment to
prevention. This, however, makes it unpopular with both
pharmaceutical companies and their buddies in the FDA, who have
more motive to make sick people better than to keep well people
from getting sick. Wojcicki said she was told by one doctor that,
“the problem with 23andMe is that you generate non-billable
information.” 

Non-billable, private information—23andMe allows
consumers to access their genetic info without a physician,
insurance company, or government middleman (which is probably
another strike against it in the FDA’s eyes). “Everyone has the
right to their genetic information and to use it,” said Wojcicki.
For now, however, 23andMe doesn’t have the right to tell you how to
get that information.