Company: Pacira Pharmaceuticals:
Title: Chief Administrative Officer, General Counsel and Secretary
When Kristen Williams got a call from a former colleague about taking on the in-house legal work for Pacira, she knew generally what to expect if she got back into the biotech biome. The two had worked together before, at a biotech bought out by a larger drugmaker.
Williams intended only to do some legal consulting for Pacira and then return to raising her three young children. What she didn’t envision was that she not only would stay on, but that she would find herself suing the FDA.
It is a risky maneuver for even a large company to sue the pharma industry overlord, a regulator that has ultimate power over any drugmaker. It's particularly risky for a company that relies on a single approved product. But when the FDA slapped restrictions on the small company’s marketing, Williams knew it was the right thing to do.
“Suing the FDA is something you do as the last resort,” she said recently. “We felt so strongly that in this instance, they were wrong and we were right.”
With the board’s approval Williams took action, and it worked.
The closely watched legal battle started in September 2014, when the FDA issued a warning letter to Pacira for promoting its surgery pain drug Exparel for pain relief in surgeries that the FDA said were not listed on its label. The FDA cited the fact that the drug’s 2011 approval was based specifically on studies in bunionectomies and hemorrhoidectomies.
But Pacira countered, saying that approach was consistent with the FDA's guidance for analgesics seeking a broad indication. Exparel also was approved for "administration into the surgical site to produce postsurgical analgesia,” the company pointed out, and its label does not specify any limitations to use based on surgery type.
For a year, the company followed the various recourses for appealing the FDA’s action, but to no avail. That only thing left to do was to sue.
There was some fortuitous timing involved. A month before Williams’ company filed its lawsuit, the FDA lost a free-speech marketing ruling in a case brought by fish-oil drug maker Amarin. When the Pacira case popped up, the FDA moved quickly to head off the chance for another defeat. Just weeks after Pacira sued, the FDA reconsidered its position and rescinded the warning letter. By December, the matter was resolved, and Exparel won the label language Pacira had requested
It was a legal fight that required a fine balance, and, acknowledging that she is generalizing about gender a bit, Williams said she thinks some of her “female traits” helped the company navigate a very delicate situation. As a lawyer, she never saw herself as hard-nosed litigator, but as a problem-solver. She thinks that because of that approach, the company’s relationship with the FDA remains solid despite the litigation.
“You try to do it as respectfully as possible,” given the situation, Williams said.
“You take the high road,” she went on. “It was a very amicable conversation with them. We very quickly got the right people to the table. We could have taken a gloating attitude or said they were a horrible agency for the action, but we didn’t.”
When Williams initially got involved with Pacira in 2011, she planned on helping the startup get its legal department in place and then hand it off to someone else. “I had just had my third child in a short time. I had a 4-year-old, a 3-year-old, and a 4-week-old child at home.” And home was just outside Denver, whereas Pacira was split between offices in New Jersey, and manufacturing and R&D in California.
But in short order she got “sucked in” to Pacira. Williams fell for the product, the people and their passion. The leadership, in turn, was quite impressed with her “customer service approach” to all matters, legal and otherwise. They named her chief administrative officer, in addition to her general counsel role. She now oversees HR, IT and compliance.
As a smaller, but growing company with a biotech frame of mind, Pacira accommodated her family needs. Williams, 42, still “technically lives in Denver,” where her husband is a general counsel in the mining industry, but obviously spends much of her time on one coast or the other, or in the U.K., where Pacira is setting up additional manufacturing operations.
Pacira has grown to a workforce of more than 500 employees and a leadership team of 7. As part of her HR oversight role, Williams has initiated programs to cross-pollinate the company, like having sales folks from New Jersey visit the manufacturing and R&D operations in San Diego, so each can understand the vital part the other group plays.
Because Pacira is such an embracing place, she has felt no need to do anything special for women, she said.
“We have a really great culture. I don’t know what it is. It’s really natural here. It is informal, instead of forced, if that makes sense,” Williams said.
Two women serve on Pacira’s board but Williams is the only female in the leadership group.
Overall, it has been easy for the company to bring in a lot of women, Williams said. There are women VPs, and plenty of women engineers and scientists. In fact, women in R&D and manufacturing are out preaching to the world about the opportunities for females in pharma.
Pacira is taking that pitch to younger audiences as well. It has program with middle school girls to bring them into the California facilities and show them what Pacira is doing. “It is a very natural, very great company to work for as a woman,” she said.
Williams knows that start-ups and biotechs are probably more accommodating than Big Pharma. “Pfizer wouldn’t hire me and let me live in Denver,” she said.
Still, she understands that it is not personally easy for many women to master the life-work balancing act necessary to the C level in biopharma. But she thinks business is getting a little smarter about figuring out how to accommodate those things.
“It is so hard, when recruiting, to find the right person, period,” Williams said. “By increasing the pool, and taking a look at women, you increase the chances of finding that right person.”