Genetics Entrepreneur Compares FDA to DMV

(p. 1) MOUNTAIN VIEW, Calif. — In 2007, Anne Wojcicki, then 33, lassoed the moon.
She was getting her new company, 23andMe, a mail-order genetics testing firm, off the ground with her “Party ’til you spit” celebrity get-togethers.
She married Sergey Brin, the cute co-founder of Google, also 33 and already one of the richest men in America, at a top-secret Esther Williams extravaganza in the Bahamas. The bride in a white bathing suit and the groom in a black one, they swam to a sandbar in the Bahamas and got hitched in the middle of the sparkling aquamarine ocean.
Soon after the marriage, as Mr. Brin accumulated more power, a yacht, and a fleet of jets, Ms. Wojcicki became pregnant with the first of their two children and Google invested millions in her start-up, named after the 23 paired chromosomes that consist of our DNA.
But six years later, the Silicon Valley fairy tale was shattered by two public humiliations: Mr. Brin got involved with a beautiful young Englishwoman named Amanda Ro-(p. 12)senberg, who provided a public face for Google Glass — an attachment that broke up his marriage. And the Food and Drug Administration shut down the primary function of Ms. Wojcicki’s business, calling her D.N.A. spit vial “an unapproved medical device” and imposing stricter rules for consumer genetic testing. Her business, once so ripe with promise to tackle health issues, was curtailed to its ancestry testing division.
. . .
“In some ways, when you have that many bad things happen, it’s a sense of disbelief,” she says. “This was one of those situations where there’s two aspects. A divorce and the F.D.A. There was no workaround in either. So it was one of the first times in my life where you have to accept, you have to actually change. Like, I need to come up with a different way of approaching both of these relationships.”
. . .
(p. 13) She’s focused for now on her children, her new Bengal cats and her company, which has more than three million customers and its own drug-development program. It started selling kits in CVS and Target, got the F.D.A.’s permission to resume giving consumers health reports on 10 conditions, including Parkinson’s and Alzheimer’s, and the $99 ancestry kit won a spot as one of “Oprah’s favorite things” this year, with Oprah calling it “The Ultimate Selfie.” Fast Company portrayed Ms. Wojcicki as the Comeback Kid of tech.
She realized that she had a treasure trove of DNA data and began teaming with Genentech and Procter & Gamble, which started mining it to make breakthroughs in Parkinson’s, depression and skin care.
In many ways, her struggle with the F.D.A. was a microcosm of the increasingly tense battle between hidebound regulatory agencies and freewheeling tech companies.
Although some people thought Ms. Wojcicki would have to sell her company, she healed the breach with the F.D.A. the same way she healed the breach with Mr. Brin. She did not huff away and seethe and backbite. She “put one foot ahead of the other,” as her mother advises, hired the best regulatory experts and found a respectful new configuration for the relationship.
“We were not communicating in the right way,” she says of the period the F.D.A. felt it was being ignored. “We were not showing Silicon Valley arrogance. We just were running around with our shoes on in a Japanese house. We were not a cultural fit and we weren’t expressing what we were trying to do in the right way.
“Some companies are trying to circumvent the regulators. We weren’t. We just got caught in the cross hairs. We clearly pissed them off. It took us a long time to generate a lot of data to prove that our intentions actually were right. But I feel like we’re doing the right thing in terms of proving that the customer is capable of getting this information on their own.
“I see it from the F.D.A. perspective. It’s a new product. It’s genetics. It’s direct to consumer. It caused anxiety. So, you know, the onus was on us.”
She had to explain to her team: “Listen, when you go to the D.M.V., you don’t argue about the vision test. You don’t say, ‘Oh, I just had a vision test. I don’t need to do the vision test.’ Like, you just do it. The F.D.A. is in charge of public safety, and I have a respect for the job that they have to do. And we’re just going to do the job that they’re asking us to do.”

For the full story, see:
Maureen Dowd. “‘Adapt and Evolve.” The New York Times, SundayStyles Section (Sunday, Nov. 19, 2017): 1 & 12-13.
(Note: ellipses added.)
(Note: the online version of the story has the date Nov. 18, 2017, and has the title “‘The Doyenne of DNA Says: Just Chillax With Your Ex.”)

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