After a Point-Blank Rejection Letter From the FDA, This Founder Went Back to the Drawing Board Cindy Whitehead spent years working on a treatment for low sexual desire in women. When the FDA rejected her drug, she disputed the decision with the stories of affected women -- and won.
By Hayden Field •
In the Women Entrepreneur series My Worst Moment, female founders look back on the most difficult, gut-wrenching, almost-made-them-give-up experience they've had while building their businesses -- and how they recovered.
After over an hour, Cindy Whitehead still couldn't move from an airport bench. She was in shock. By way of a fax, a text and a phone call, she'd just discovered that the FDA had rejected her new drug application for Addyi -- the treatment for low sexual desire in women that she and her team had worked on for years. Whitehead, founder of Sprout Pharmaceuticals, thought it was the end of her business, which couldn't have been further from the truth. Here, Whitehead tells us how it happened -- and how she, with the help of women affected by low sexual desire across the country, turned things around.
This interview has been edited for length and clarity.
"After years of building Sprout Pharmaceuticals to achieve a breakthrough for women by getting the first-ever drug approved for female sexual desire, I faced the worst moment of all: When I found out that the FDA had rejected Sprout's new drug application for Addyi with the data of more than 11,000 women.
I was traveling back into Raleigh, and I had just been on a business trip up in New York. As soon as I landed, I had a text: "Call me." I called the office, and they gave me the news that a letter from the FDA had come through. We had been turned down. I was blindsided. Outside of [airport] security, I sat down on a bench right near the exit. I couldn't move for a while -- maybe two hours -- because, at that moment, the whole business felt like it had gone up in smoke. Time stood still.
That rejection signaled the end of my business. My fate felt entirely in their hands despite the evidence -- we had submitted studies to the FDA in which we'd demonstrated scientifically what we'd been asked to prove. The letter didn't come with a lot of guidance, but their "no" was essentially the notion that the benefit the drug offered was only modest. The average number of sexual events women experienced per month after taking the drug was one -- but if you adjust and look at only people who responded to the drug, the average was four to six. What I think was happening there is that "modest" sounds like "minimal" -- but for females with this condition, "modest" is meaningful.
For example, I don't administer an antidepressant to make a patient euphoric -- I use an antidepressant to restore a patient to a normal they once knew. It's exactly the same for women with hypoactive sexual desire disorder (HSDD). You're not making women hypersexual -- in fact, that would be an undesirable outcome. But the condition was threatening women's self-confidence, relationships -- in many cases, they had broken marriages. In science, and in these decisions particularly, everything comes down to benefit risk. If I assign no value to the benefit of something, then any risk would be too great. I saw the decision as a value judgment in terms of the worthiness of this condition to treat. It was a wake up call for how differently we in America approach male/female health, and I hadn't anticipated the subjectivity. Why were we making the judgment to how much improvement for these women was "enough"?
It felt like an eternity that I was sitting on that bench, because I knew that no matter how long I sat there, I wasn't going to have the epiphany of how to fix it. I hadn't a clue what I was going to do next. Finally, I picked myself up to head to the office.
I told my team immediately and without hiding my emotion. I was blindsided; they were going to be too. That's not the time for a pep talk -- it's the time for group therapy if you have a culture of honesty. People talked about losing the cause they cared deeply for -- so much blood, sweat and tears put into it -- and the prospects of us shutting down. We all agreed to take the weekend and totally disconnect.
I went home and took to the bed with a lot of tears. I think those tears were about letting people down. To start over meant millions of additional dollars that I would have to go ask for from people who were expecting a good outcome. It was daunting, and it seemed insurmountable. And then the next morning, the sun comes back up, and you've got to figure out what you're going to do next. As therapy, I went to my inbox and re-read all the notes from women suffering with this medical condition. Women who were losing their marriages and their lives as they knew them. Email by email, I reminded myself why I had to stay the course. I met one patient in person who had been in the clinical trials -- she cried alongside me and told me her story. For her, I decided, this is why I'm going to fight.
On Monday, I told my team that I'd made the decision we were going to dispute the FDA. The path was full of twists and turns, but I was determined to have people hear what the actual women suffering with the condition had to say. To the credit of the FDA, they opened their doors and listened -- via a public meeting where they let patients share their personal stories and asked them questions. Once we assigned value to treating this condition, the outcomes of our trials had more meaning. A panel of 24 scientific experts reviewed the data and voted 3 to 1 to approve the drug. When they read the vote, a room full of women erupted in cheers. Witnessing that, I had truly gone from the lowest low to the highest high.
From this experience, I learned to, in the toughest of times, always return to the heart of why you're doing something. It might take time, but the side of right usually wins. From a self-reflection perspective, I learned the power of my own resolve. And from a global perspective, I learned the power of women advocating for themselves and each other. I had the most incredible front-row seat to women who were -- from every walk of life, from every corner of the United States -- brave enough to come to a federal agency, open the doors of their figurative bedroom and share their most personal struggles in the interest of changing that for all women. While the road less traveled is scary at the outset, you will be amazed by all the people who come and walk beside you once you have the courage to take it."
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