'Do the Right Thing'

January 19, 2016

At the FDA, Janet Woodcock '70 blazes the pathway to safe and effective drugs.

It isn’t easy maneuvering around the sprawling, well-manicured White Oak Campus in Silver Spring, Md., where Janet Woodcock '70 presides over the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). The mazelike layout of the campus gives one indication of just how complex Woodcock’s job is directing CDER, whose mission is ensuring that drugs are safe, effective and available.

Finding one’s way to the proper high-rise building and then through the security phalanx and up to her sixth-floor office takes time. Everything about Woodcock’s vast area of responsibility takes time. Managing 45 offices and a staff of 5,000 government employees, this research-scientist-turned-CEO oversees the approval of all prescription and nonprescription drugs in the United States.

On their way to her office, visitors pass through a room where exotic orchids are arrayed on workers’ desks. To the right is a walkway to another building, which is lined with large, leafy green plants, grown and bestowed, as were the orchids, by Woodcock, an inveterate gardener.

Woodcock greets visitors in her large corner office, with its beige wood furniture and a balcony that overlooks the White Oak grounds. Prominent on the walls are photos of her two daughters and art by the one who’s in medical school now. Petite with short brown hair tucked behind her ears, Woodcock has an easy, warm manner and a steady smile as she speaks.

When asked how long it takes to get a drug approved, she spends a patient 10 minutes explaining every step.

The Long Road

Going from research conducted in university science labs to the pharmaceutical company-funded predrug development stage can take years. Next comes drug discovery in the pharmaceutical labs. More years. Then there’s the clinical phase — testing in animals, then in humans. Summing it up, she says, "If you go really far back, when you’re first identifying what causes a disease, it might be 25 years until you get [the drug] into people."

That’s why many Nobel laureates, such as the three scientists lauded in October for developing drugs to treat parasitic diseases, are in their 80s. "With the Nobel, you can’t just discover something," she confirms. "It has to have made a difference. Sometimes that takes 25 to 40 years. So the Nobel is a good measure. One of my goals is to accelerate our part of the process — to make it as efficient as possible but to still get all the information."

Once the drug companies successfully pass the trials stage, she says, "they assemble all the information, which includes how they make the drug, where they make it — plus details on the pharmacology, toxicology and human studies. Then they draft a label. That’s called a new drug application. Our review process takes six to 10 months, which is very short compared to [all the years spent in development]."

A program she started for breakthrough drugs has fast tracked some that have been, she says, "real game changers for serious diseases. We’ve been approving them in something like three months."

"The science of drug development is really changing now and is very promising," she says. "We’ll be able to crack some of these diseases and treat people who were previously untreatable. Every year we’re approving drugs that do that or cure diseases, like hepatitis C, that were intractable before."

Among other new advances that come under her purview are printable drugs, created by 3-D printers. "We just approved our first printed drug, for epilepsy," she says. "Drug manufacturing is one of the new frontiers. The rigorous chemistry training I got at Bucknell has served me in good stead supervising all of that.

"Sequencing the human genome has caused a big revolution in how drugs are developed and administered," she adds. "That scientific revolution has been pretty fast, given that the sequencing of the human genome was 15 years ago." Her job involves, "great science all the time. Of course, it’s all mixed up with lawsuits all the time," she adds with a smile.

Quest for Lower Prices

While the FDA reviews drug-development data, it doesn’t fund drug research. That’s on the pharmaceutical companies’ dime. The FDA also "has no role in how drugs are priced," says Woodcock. She invokes former FDA Commissioner Mark McClellan’s concerns about affordability.

"That was back in 2004," she recalls. "I wrote a report in which I discussed what we could do in FDA-regulated phases to make drug trials and development programs more efficient and effective. We’ve done a huge amount with public-private partnerships to simplify trials and we’re still working on that." She’s also counting on innovations such as electronic health records. "We can help reduce the time needed for trials", she says. "I believe we can lower the cost of developing drugs through some of these measures."

One of Woodcock’s top challenges in drug development and regulation is figuring out why some people experience adverse reactions to new drugs and others don’t. Sequencing the human genome has brought about tissue typing to detect if someone has a rare allele that could react adversely to a drug. "We’re trying to understand the biological basis of different human responses to drugs," Woodcock says.

Strictly Science

During her 30 years with the FDA, Woodcock has worked under several presidential administrations. While presidents may express interest in certain topics — for Obama, it’s been the epidemic in prescription opioid abuse, she says — the FDA has been largely immune to the political winds. "The fundamental work is very scientific and we like to keep it that way," Woodcock says. “We’re more successful the more we keep it strictly based on policy and the science that we have.”

Woodcock came to the FDA in 1986 as a part-time drug reviewer. A rheumatologist and new mom, she’d been on the faculty at the University of California, San Francisco doing research in rheumatology when her husband got a job at the National Institutes of Health in Bethesda, Md.

"I was hired by a biologic center, because I had experience doing research on monoclonal antibodies, which were very experimental," she explains. Because this was the height of the AIDS epidemic and she was helping to regulate a therapeutic vaccine, "I got thrown into media things right away. 'Oh, you can do 60 Minutes.'

"Pretty soon I was supervising the whole IND [Investigational New Drugs] Division at CDER and then I was deputy director," she says. She’s been CDER director since 1994, except for a few years when she served as the FDA’s deputy commissioner and chief medical officer.

When asked how she manages to lead an operation of 5,000 people, she says, "I’ve always been looked to as a leader. At Bucknell, they made me captain of the cheerleaders. I was terrible at it, but I’ve always been somebody that people look to and ask, 'What’s the next step?' "

Besides providing Woodcock a physical outlet for four years as a cheerleader, Bucknell gave her a scholarship and "a really rigorous education," she says. "All the parts of it have really helped me. Medical school [at Northwestern University] was fairly straightforward for me."

One of Woodcock’s chemistry-major requirements at Bucknell was particularly memorable. "We had to blow our own vessels and I probably would have inhaled molten glass or done something horrible if not for my lab partners. So I thank them for helping me and allowing me to graduate."

She’s no longer cheerleading, but she maintains her lifelong penchant for physical activity. "I do aerobics and have taken up running again," she says. "And I go hiking all the time" — recently in Iceland and Banff. And then there’s her gardening — flowers, fruit and vegetables — at her place in rural Brookeville, Md. "Having grown up in Pennsylvania [near Altoona], I like the country," she says. "My job is so intense that when I go home I just want to go out in my garden. I garden a lot."

Beaking News

Woodcock’s straightforward, candid manner makes her a natural spokesperson for the FDA. If you read or watch the national news, including newsmagazine shows, you’ve probably seen her explain the benefits of biosimilars, generic versions of biologic drugs (CBS News, March 9, 2015). Or address the overuse of prescription painkillers or opioids, as she did in Time in June ("No one anticipated the clinical community would take to this and start giving it out like water.").

The opioid addiction problem is immense. According to Time, 9.4 million Americans take opioids for long-term pain and 2.1 million are estimated to be addicted and potentially turning to the black market. Woodcock contends that the FDA is working with states and physician communities to address the problem and has written guidelines on "abuse-deterrent formulations — versions of the pills that you can’t snort very well or can’t inject. We’ve done a variety of different steps to mitigate the epidemic."

The FDA’s approval of the narcotic painkiller OxyContin for use in children caused a stir this fall, as some lawmakers and politicians claimed the move could lead to more OxyContin prescriptions, further fueling the prescription opioid epidemic.

Woodcock boldly told The New York Times, "There are children in need. It would be unethical not to have the right dose information. It has been a real scandal that children in the United States receive drugs without proper evidence of their dosage and safety."

Because she is dealing with breaking issues in public health she’s had to respond quickly. "You can never predict a crisis." Woodcock reflected on a 2008 catastrophe, when an estimated 150 Americans died from contaminated doses of the bloodthinner heparin, which had been manufactured in China. "We responded quickly and that was complicated," she says.

Woodcock’s comment is sought on hot topics in the major media nearly every week. In the last few months, for instance, she’s addressed the approval of the new female libido pill, Addyi and the FDA’s call for new labels on over-the-counter painkillers, such as ibuprofen and naproxen, that warn of increased risk for heart attack and stroke.

"Over-the-counter drugs have to be safe enough for people to be able to misuse them in various ways," she says. "People aren’t going to follow the label instructions. The drugs have to have a good margin of safety or they shouldn’t be [sold] over the counter."

Under Pressure

Besides the pressure of responding to media calls, there’s the pressure applied by drug companies and desperate patients who want the FDA to expedite drug approval. "Our salvation is that we have scientific standards and we try to stick to them," she says. "The patients have trouble understanding that, but the industry understands pretty well, though they may not be happy about it."

Woodcock frequently meets with groups affected — parents whose children are dying or dying patients — to explain the drug-development process. "That is our duty as public servants," she says. "But we can’t satisfy their need for something if there’s nothing out there.

"Everybody has an opinion — Congress, the [presidential]administration, the media, the patients, drug companies," she continues to say. "Long ago, it bothered me more when people were shouting. But to maintain in this job, you have to get to a point where you just do the right thing, do the right thing. Analyze the situation. Do the right thing."