Some Of The Most Powerful Women In Tech Tackle FDA Regulations
At Fortune’s Most Powerful Women conference in San Francisco, two female tech executives discuss battling the FDA — and winning.
23andMe CEO Anne Wojcicki on stage with Fortune's Pattie Sellers at the Most Powerful Women Next Gen Summit in San Francisco.
High-powered women from across a number of industries gathered at the RItz Carlton in San Francisco on Tuesday evening to kick off Fortune's Next Gen Most Powerful Women conference. The conference, which focuses on tech, includes executives from companies like TaskRabbit, Google, Facebook, Stripe, Instagram, GoDaddy, and more, plus a number of startup founders. The CEO of SoulCycle received a round of spontaneous applause just for being present, and jokes about spin class were met with raucous laughter.
The evening's programming featured one-on-one interviews with health tech CEOs, including 23andMe's Anne Wojcicki and Sprout Pharmaceutical's Cindy Whitehead. Both companies have struggled with with FDA approval in the past, and each was asked to discuss how they dealt with regulatory obstacles.
After two years of waiting, 23andMe finally won approval from the FDA in February, and started selling the tests again five weeks ago. CEO Anne Wojcicki said, during that time, she never lost focus on the company's core mission — bringing genetic information and healthcare directly to consumers.
"I think honestly one of the smartest things we do is, we don't read our press," she said. "We keep getting this feedback, our investors, people who were part of the raise — the vision has not changed for 23andMe. It has been so obvious that what we said we were going to do is exactly what we're executing on. When we had the FDA warning letter and other issues, they're just bumps. It's just a problem to solve. What we've learned is, we can solve those problems. Nothing was insurmountable, it was just a question of figuring out the situation. We just buckled down. As soon as we got our warning letter, I spent ten days in my pajamas on the phone with lawyers getting feedback."
Wojcicki went on to say that while direct to consumer sales of 23andMe test kits will always be the core of the company's business, data from over a million users will increasingly power the companies drug research and development arm. Within five to ten years, she said, it's possible that the company's major source of revenue could shift toward drug discovery.
Sprout Pharmaceuticals CEO Cindy Whitehead.
Sprout is a very different kind of company. First of all, the drug it's known for — Addyi, a female sexual desire enhancer — isn't something the company discovered itself. CEO Cindy Whitehead was working for a company that sold "one of the male sexual health drugs," and was frustrated when she saw executives passing up on the chance to fund a similar solution for women. "They weren't walking away on the basis of science. The science and emerging understanding is spectacular," she said.
The problem, Whitehead said, is that people see male sexual dysfunction as biological, while female sexual dysfunction is psychological. And, indeed, Addyi is a "chronic drug" that treats Hypoactive Sexual Desire Disorder, which is classified as a mental disorder. "Addyi is an everyday drug that works on key chemicals in the brain — that's very different than a blood flow issue," Whitehead said. Addyi, which has gained a lot of attention as "the female Viagra," was rejected twice by the FDA before finally winning approval in August. When asked if she was surprised by the controversy the drug has stirred, Whitehead was dismissive. "No," she said, laughing. "It's women and sex."