From tiny Woodburn, Ind., to Washington, D.C., Food and Drug Administration Commissioner Dr. Jane E. Henney never faced a hurdle she couldn’t leap.

The New Physician, November 1999

She was homecoming queen. If you know any facts about Jane E. Henney, this is probably not one of them. It’s not that it’s a great secret, a diamond of a tidbit unearthed from the past. Just four words notable for their simplicity. One of the nation’s most accomplished women doctors, with a résumé as ongoing as her Midwestern roots, once stood before her peers at Manchester College in Indiana wrapped in the swath of the traditional female popularity contest. A tiara of tradition.

It is, quite probably, a disservice to old-school feminists to begin a story about the rise of the first woman commissioner of the Food and Drug Administration (FDA) in this way. A crown, some flowers, the idea of a man presenting you on his arm while leading you down a path—too much style, not enough substance. But this is not a narrative about fitting a mold, or not fitting a mold. It’s about a woman who grew with her small-town values, who worked hard, loved fairness but not politics and dreamed big even when dreaming seemed impossible.

Doc Niswander saw the dreaming in action—in fleeting, riotous, exuberant action—one day in 1968. He peered out the window of his house near the Manchester campus where he taught anatomy and physiology, and there was quite a sight: Janie Henney, smile stretching and legs flying, beating a path like Achilles to his door with a golden ticket in her hand.

“She had just pulled it out of her mailbox,” Doc says. “It was her letter of acceptance to medical school.”

Tradition, it is safe to say, faded to the background of Henney’s life that day, replaced with a little something the rare folks among us embrace. It’s called Passion, with a capital “P.”

A LEADER FROM THE START

Now Henney sits as comfortably as a teenager in jeans on the couch of her office—only with decidedly more grace—swinging one leg vertically in front of the coffee table. She is a tall, thin woman of 52, her hair pulled back in a bun, her forehead creased with only the kind of wrinkles that seem to speak more of unending youth than of old age. Since she won a hard-fought nomination to the top FDA post 13 months ago by dazzling the Senate Labor and Human Relations Committee with her thorough intellect, Henney, an oncologist by specialty, has kept a quiet profile, rarely speaking to the press. She prefers to be less a mouthpiece of the FDA than a doer.

Though her friends call her a pioneer, she seems more like a woman with unfinished business to take care of in public health—business that began with the Student American Medical Association (SAMA), the precursor to the American Medical Student Association (AMSA). Henney first stepped into the public-health arena while a student at the Indiana University School of Medicine, where she became a leader in her SAMA chapter. She never looked back.

“At that point in time, medical students really didn’t have many opportunities early on to get clinical experience outside the tertiary care center,” she recalls. “So what we did was place students for the summer, particularly between their freshman and sophomore years, in smaller communities. We teamed them up with local physicians, who not only let them get involved in what they did in their practice every day, but also involved them in all the other ways a physician is called upon to be a leader in the communities in which they serve.”

The Medical Education Community Orientation [MECO] initiative had humble enough beginnings in Middle America. It began with a small grant from the Sears Foundation, but grew to become SAMA/ AMSA’s historically largest community health program. Thanks in part to an article Henney wrote for the Journal of the Indiana State Medical Association in November 1971, the program garnered enough attention in the region that Henney and her cohorts obtained a full grant to take it national.

“The real success of the program, I think, came when those grants ran out,” she says, “and many of the states had become so enamored with the program that it started to institutionalize either at the medical school or within the state legislature. They wanted to keep the program going. So even though AMSA’s involvement was still a presence, it had ownership at a far different level. Being from a small town, MECO was something I was just naturally drawn to. It was enormously fulfilling.”

In addition to the leadership skills AMSA honed in Henney, who in later years served as president of the AMSA Foundation, she got a little something more out of the experience than simple knowledge.

“I had the opportunity, and the very rich opportunity, to meet medical students from all over the country, people I never would have met if I had gone through the typical grind of going to school, going to clinic, meeting the students who were in my own classes and no others,” she says. “I would say that the friendships I developed in that medical student association are as strong as some of the friendships I developed in college or medical school. And I still retain them.”

In fact, Henney will celebrate her 20th wedding anniversary next June with one of those friendships: her husband, Dr. Robert Graham, former executive vice president of the American Academy of Family Physicians.

EMBRACING ENORMITY

Upright. Professional. These are the words most often used to describe her. That, and beautiful. “She never dated much in college,” Niswander says in disbelief. “She was very devoted to her work.” These days, Henney devotes herself to the agency. It’s a tremendous amount of responsibility, greater perhaps than the general public realizes. But responsibility is as central and binding to Henney’s very core as is the air she breathes. Always has been.

“The way we learn from problems that are unsolvable, the way we can turn something hopeless into something possible—she thrives on that,” says friend Jo Young Switzer, vice president of academic affairs at Manchester and a former classmate.

“Actually,” Henney confirms, “that’s part of the enjoyment of the job, the enormity of it. I really love complexity. I enjoy working with people. So making complex things work and working with strong and dedicated people on behalf of others—it’s a dream.”

Indeed, wherever she has been, be it as the vice president for health sciences for the University of New Mexico School of Medicine, the interim dean/vice chancellor for the University of Kansas School of Medicine, or the deputy director of the National Cancer Institute, Henney has been a problem-solver.

One of the greatest quagmires the FDA regularly encounters is finding the budget to reign over its vast jurisdiction, which includes everything from pharmaceuticals to artificial sweeteners. During her last go-around at the FDA, when she was the deputy commissioner for operations from 1992–94, Henney was instrumental in revitalizing the agency’s drug and biologics review system through the Drug User Fee Act of 1992. Henney calls the law “proof certain that when the agency is provided with adequate resources, it is up to the challenges it is given.” By infusing the review system with funds from fees paid by drug companies whose products were waiting for approval, the FDA sped up the process of getting life-saving medicines to doctors and the public.

But opinions are plentiful, and even a tool as seemingly useful as the user-fee program battled criticism as Henney traveled through the FDA head confirmation process. One conservative think-tank observer, Henry I. Miller, wrote in The Wall Street Journal: “Dr. Henney is a quintessential Clinton choice: a true believer in arrogant, intrusive, damn- the-expenses government regulation. While she was the deputy commissioner, the regulatory burden on drug companies grew….”

But Henney proves what those close to her contend: that she will steadfastly, if graciously, stick to her guns.

“It’s not like any of our decisions are easy,” she says. “But are they important? Do you feel like you’re making a difference? That’s the thrill of any job. Do some people think you’re wrong at everything you do? Yes. Do some people think you’re a great heroine? Yes. But you have to set your own internal satisfaction and your own comfort with your decision-making. Otherwise, this job could drive you crazy.”

One decision Henney wishes the FDA had been able to avoid were a rash of drug and product recalls over the past year—and five drugs since 1997.

“What we found in a nutshell was that the speed of the review really had not been the problem,” she says, punctuating each word with an arm outstretched toward her interviewer. “The problem most often was that once they got into the marketplace, they were used in larger settings than ever would be used in a study setting, or they were used in ways that were never contemplated by the indications that were on the label.

“And no matter what we did as an agency in terms of how to inform individuals or health professionals of how to use these products, they continued to be used in a way where the risk started to outweigh the benefit. And so we were forced to the final endgame of not just putting out more information on a label or in educational materials, but in actually having to say, ‘We can’t have this. It’s gotta be recalled.’”

For Henney, it’s an endgame to be abhorred, to be prevented in any way possible. Everything, she says, has some sort of risk, because once her agency gives a product the nod, it goes into the open marketplace, where physicians and patients handle their own risk management.

“The challenge that we will present medical students at the FDA in coming years is also a great opportunity,” she says. “The onslaught of new products is going to be even greater. One of the first orders of business, then, for future physicians is to reach a comfort level and a knowledge level with those products that they are going to use on behalf of their patients. That means making sure they are well used and appropriately prescribed, and that they well inform their patients about those products. That is the key.”

Her comments, those of a federal agency head—those of policy and implementation and efficacy and all those other ’tions and ’acies—are rather freshly interrupted by the sort of wishful, hopeful, I-believe-we-can-do-this smiles not often seen in bureaucracy. Perhaps this is because she fancies herself less of a bureaucrat than a peoplecrat. Folks with passion will do such things, as if to remind the rest of us that there is a human face behind everything we do. And yet, it’s true, she and the agency she heads do command 25 cents of every dollar your loan money spends, 25 cents of every dollar your mother spends, one quarter of the contents of the pockets of everyone you treat or will treat.

So shouldn’t she be as well known as Alan Greenspan? Shouldn’t we be watching her briefcase for marketplace indicators?

Henney gives a laugh that comes from her toes. “Well, there are pluses and minuses to that happening,” she says in an ironic, throaty voice. Then, with a graceful, state-dinner tone: “I have had the privilege, ever since I started my career, of working for very public institutions. Dealing with the public arena is something I’m accustomed to. The impact of the FDA, however, is very different, because the FDA really does impact every single individual in this country every single day.

“I don’t think it’s important that ‘Jane Henney’ be on the lips of every single American, or that her name be known, but that people have an appreciation for what this organization does on behalf of the public health.”

That’s quite a departure from the very public face her predecessor at the FDA, Dr. David Kessler, brought to the vanilla-bean-inspired office in Rockville, Maryland. Kessler, who left in 1997 to head the Yale University School of Medicine, thrust the role of FDA commissioner into the political spotlight with his efforts to commandeer nicotine product regulation as an agency duty. Criticism of Kessler’s publicity-minded agenda frequently ruffled feathers on Capitol Hill and elsewhere.

“Our budget suffered terribly over the last five years with David in charge,” says Linda Suydam, a senior associate commissioner at the FDA and chief of staff for the Office of Tobacco and Public Affairs. “People on the Hill were very upset with him. Dr. Henney is more open, more contemplative. They are two very different people. She loves to make organizations run efficiently; he was not much for structure.

“There are advantages and disadvantages to being high-profile. You can galvanize the public to certain issues, but you can also galvanize opponents,” Suydam says.

Therein lies one of Henney’s largest challenges as commissioner. The politics. Industry wants quick reviews of products for more revenue. Physicians want quick reviews of drugs for better patient results. Congress wants whatever the little old lady in Peoria wants, which is a little of both. And the FDA’s job is to want everything everyone else wants, as safely as humanly possible. Pressure? Nah.

“There’s always a balancing of forces and interests that go on when you’re dealing with a regulatory agency of any type,” she says. “But I find that if we make our decisions here at the FDA and make sure they are firmly grounded in science, we stand on firmer ground. We make decisions that are in the interest of public health. Sometimes that’s as disruptive and unpopular to consumers as it is to industry, but if we’re not in a place where we can defend a decision based on scientific evidence, then we very quickly lose a position of strength.”

She has—if not the in-your-face, “fight authority” chutzpah of a Mellencamp muse—the Midwestern, three-stoplight, Little-Pink-House security of her mind and its contents. If Jane Henney’s FDA is political, and it surely must be if reachable by an exit off the Washington Beltway, it is so only by peripheral coincidence. That, say friends, is why she will be remembered as the “most qualified FDA commissioner in history” and a woman with very few enemies.

“She brings integrity to whatever she does,” Switzer says. “You know that whatever she’s associated with is going to be fair and sensitive to the needs of all groups of people. She’s not buffeted by fads or trends. She brings a lot of small-town with her wherever she goes.”

‘WELL, WHY NOT?’

It is a timeless refrain, of course, in stories like these. Small-town values. Small-town wisdom. Small-town dreams….

“I can remember going to the doctor in my small town, Dr. Mosier,” says Henney with a wistful smile, “and being fascinated by what went on in a physician’s office. It was the kind of office that still had all of those amber pill bottles on the wall, and he was the quintessential sort of Norman Rockwell physician. He took care of everybody. When you went to the doctor, you dragged your dolls, you took your dogs…and he just sort of paid attention to it all. He was just a wonderful and revered person in the community.”

Henney drew her strength from the people she knew in tiny Woodburn, Indiana, population 512. A friend of the family died of breast cancer, a woman whom Henney calls “a town heroine.” She was drawn to the woman’s courage; it taught her much of inspiration. And then there was her mother, who Henney refers to as “Rosie, the Riveter.”

“My mother so desired to go to college, to have a career, but she truly was living in a time when that wasn’t possible. She became a secretary, but she wanted a college education—probably so bad she could taste it. But she came from a family with nine children and lived on a farm. There wasn’t enough money. So from the time we could even think we were hearing something, she rammed into her kids: ‘Education, Education!’ It was a very strong value.”

So strong, in fact, that Henney was on track to become a schoolteacher at Manchester College.

“Really, when I was growing up, there were three paths you could take as a woman. You could become a nurse, you could be a schoolteacher or you could be a secretary. Even to be a social worker, an occupational therapist, a travel agent….

I mean, those occupations, for a person from a small town, just didn’t exist, let alone thinking about entering one of the professions like law, medicine, business. It’s not what women were expected to do, even if they thought about it.”

But while she took English and social-science classes, Henney was also taking her fair share of life-science courses—and loving them, and wondering….

And so one day she walked into Emerson “Doc” Niswander’s office and laid it out on the table for him. She was thinking about it. She was thinking about what she really wanted to do, and she was thinking that, well…it wasn’t teaching. It was doctoring.

What was his response to this bold young woman hoping to become one of 12 women enrolled in Indiana University’s medical school class of 250? “Well,” Niswander told her, “why not?”

“And I couldn’t come up with any ideas as to why not,” Henney remembers now with wonder in her voice. “I knew I was doing as well in my classes as the premeds were. I knew I wanted to. So I’d figure out a way.”

For his efforts, Doc, now 85 and retired from teaching, received a golden ticket of his own: to Washington, D.C., last January to see his star pupil sworn in as the first female FDA commissioner in history. And to hear her acknowledge in her speech his three simple words to her so many years ago, right there in front of the president of the United States.

“At the time,” Niswander recalls from Henney’s student years, “none of us thought about her being a leader in the public-health world. But she didn’t either. Her main aim was just to get into medical school.”

My, how things change.

“I think it’s always significant when an individual breaks a barrier, and it’s a real honor to know I’m the first female to be FDA commissioner. But,” Henney says with a sly smile, “I guess I take more pleasure in knowing that I won’t be the last.”

Like Dr. Mosier, she has become a revered person in the small towns where she got her start, whether it’s Woodburn or Manchester.

Jo Young Switzer lived on the same hall as Henney at Manchester, where Henney now serves on the board of trustees. Switzer says that whenever Henney is in town, students are anxious to hear what she has to say—and Henney is anxious to share her wisdom. She recalls that, at the height of her nomination process, Henney came to Manchester and spent 90 minutes chatting casually with 40 students from all fields of study, explaining what gave her the skills to make the shift from practicing to administrating to leading. All the classes she took, she said, including those education courses that would have put her in front of a classroom instead of an examining room, gave her the breadth of knowledge to climb to her position today.

“She hooked it right to their own experience,” Switzer says.

Recently, Henney was in town for a board meeting, and she was met with a great surprise. Out of the 1,100 students at the college, 600 of them had convened to sign an enormous card for her. Switzer recalls that one student had written these oh-so-reverent words: “You’re just too awesome!”

“I said, ‘She would never talk like that,’” Switzer says, tickled at the very thought. “She’s much more formal. But I suspect that this was a young woman who might aspire to follow in Jane’s footsteps one day.”

Riotous, exuberant, Achilles-like footsteps, no doubt. And with a crown fit for a commish.

Copyright 1999 American Medical Student Association