Alumni Profile: Modernizing Medicines

FDA stalwart Janet Woodcock looks to the future of drug making and regulation.

by BRIDGET M. KUEHN | illustration by JACQUI OAKLEY

Janet Woodcock, ’77 MD

Janet Woodcock, ’77 MD, is one of the most powerful women in the pharmaceutical sector.

As director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), she has final say on which drugs are approved for use in the United States and oversees how the agency manages emergent drug risks. During her 30-year-plus career, she’s found herself at the center of some of the biggest controversies in medicine — including the investigation of contaminated heparin and debates about side effects from blockbuster drugs like antidepressants and nonsteroidal anti-inflammatory drugs. She’s served at the agency through six U.S. presidents and testified before Congress more than 50 times.

“It’s an ongoing intellectual challenge,” Woodcock says. “It’s the intersection of science and medicine and law and policy.”

She’s been both applauded and criticized for her work modernizing the agency and for promoting more cooperation with the pharmaceutical industry. She helped ensure that the FDA was using the most advanced tools and science to evaluate new drugs through the Critical Path Initiative launched in 2004. She also collaborated with Congress and the Obama administration to craft the 21st Century Cures Act passed in 2016, which will provide the agency with $500 million over nine years to further accelerate the development of new drugs, among other things.

It’s an ongoing intellectual challenge. It’s the intersection of science and medicine and law and policy.

Her approach to drug safety is pragmatic.

“None of them are completely safe,” she says. “They all cause side effects. The question is: Can you manage them and keep the benefits outweighing the risks?”

To help the agency better track the safety of drugs over their lifespans, she launched the FDA’s Sentinel Initiative and the Safe Use/Safety First program in 2009. She was also a proponent of the Risk Evaluation and Mitigation Strategy, which the FDA uses to keep physicians updated on emerging drug risks and to develop safety plans with drug makers.

Having a good foundation in chemistry and general biology from her undergraduate degree at Bucknell University and her medical degree at Feinberg have proved critical to Woodcock’s career.

“I got a very nice solid education in medicine at Northwestern,” she says. “All my training, I use every day.”

Woodcock says she wasn’t looking for a career in regulation when she first started at the FDA in 1986, just a job that would be suitable for her. She had relocated to Maryland with her husband and their 3-month-old child after her husband took a job in the area. The agency was interested in her experience investigating monoclonal antibodies. She landed a position in the Division of Biological and Investigational New Drugs at the FDA’s Center for Biologics Evaluation and Research in the midst of the biotech revolution.

“I didn’t know anything about the FDA,” she recalls. “I couldn’t believe the kind of things they were involved in because they’re right at the forefront as science is going into humans.”

Over the years, Woodcock has served in many director-level positions, and as the agency’s deputy commissioner. During her tenure, the agency has had to adapt to a rapidly changing drug market.

“The generic industry has exploded over the time I’ve been here, and now 90 percent of prescriptions dispensed in the country are generic,” she says. To make sure the agency keeps pace, she helped bring about a program that charges generic drug makers user fees to cover some of the costs of FDA oversight.

Currently, Woodcock is also serving as acting director of the Office of New Drugs, where she is working to modernize the way its staff reviews new drug applications. She explains that in the past applications would arrive as a “tractor trailer-load worth of papers” and staff would review them, making handwritten notes. Now, standardized data arrive electronically.

With rising costs and growing drug shortages becoming pressing concerns, Woodcock and her colleagues are also striving to improve how the pharmaceutical industry makes drugs. She says that many drug manufacturers have continued to use processes that are essentially a scaled-up version of drug compounding.

“They just continue this very old-fashioned method,” she explains. “It’s quite expensive, and it’s quite prone to errors and problems.”

Meanwhile, manufacturers of chemicals, food and other products have moved on to more sophisticated, efficient and precise processes that lead to uniform results. For example, she notes, every M&M candy has a uniform coating. So, she and her colleagues are helping pharmaceutical manufacturers get up to speed through the Pharmaceutical Quality for the 21st Century program, which was launched about a decade ago.

 

“It’ll take time because there’s investment involved in switching to more advanced manufacturing techniques,” she says.

While her list of policy accomplishments is long, Woodcock says she’s most proud of her role in building the CDER into an organization capable of keeping up with rapid changes in science, medicine and politics.

“My biggest accomplishment is turning the CDER into an organization that can continue to deal with the numerous challenges that we face all the time,” she says.

WOODCOCK’S CAREER TRAJECTORY

1977

  • Graduated Northwestern with MD

1986

  • Joined the FDA’s Center for Biologics Evaluation and Research
  • Served as director of the Office of Therapeutics Research and Review
  • Oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis

1994

  • Became director of the FDA’s Center for Drug Evaluation and Research, a role she has held off and on for two decades now
  • Led the FDA’s effort to modernize drug manufacturing and regulation
  • Launched initiative to move medical discoveries from laboratories to consumers more efficiently
  • Introduced programs to improve drug safety management