2024 Paul A. Volcker Career Achievement

Janet Woodcock 

Transformed the Food and Drug Administration’s drug review process to expand access to generic medicines and promising medications to treat severe, life-threatening diseases.

When Janet Woodcock became head of the Food and Drug Administration’s Center for Drug Evaluation and Research in 1994, the agency was keeping key drug review documents on microfiche and storing miles of paper records. 

Over the 30 years that followed, whether leading the center or in the FDA commissioner’s office, Woodcock was a key driver of internal and external change who created what is seen as the worldwide gold standard for drug regulation and fostered a climate of innovation that has led to rapid advances in treatments of serious illnesses. 

“Dr. Woodcock transformed how FDA does its work, adding efficiency without compromising the high-quality work that is required of the agency,” said Andrea Palm, deputy secretary of the Department of Health and Human Services. 

For Howard Sklamberg, who worked with Woodcock at FDA from 2010 to 2017, Woodcock is considered “the most consequential public health official over the last 30 years.” 

“She is a force of nature,” said FDA’s Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and a 2021 Sammies honoree. 

Internally, Woodcock oversaw a modernization of FDA’s practices that ensured it was ready to work alongside a rapidly changing pharmaceutical industry—forcing changes in everything from paperwork processing to IT systems, reorganizing parts of the agency to promote greater efficiency and changing its relationship with drug companies. 

All this internal change enabled FDA to reshape an industry in multiple critical ways. 

“Thanks to Janet, the FDA is more prepared today for the next generation of medical innovation and breakthrough technologies that will help make lives better for millions of Americans,” said former North Carolina Sen. Richard Burr. 

Sustainable reviews for generic drugs 

Until 2012, FDA only collected what are called user fees from drug companies to help cover the cost of its evaluations of new, branded drugs. It relied on annual appropriations from Congress to fund its review of generic drugs. 

Over time, as drug development accelerated, those fees were insufficient to handle the glut of generic drugs seeking approval, meaning approvals could take many months or years to complete. 

Seeing the negative impact of these delays on consumers, and the unsustainable nature of the system for FDA itself, Woodcock advocated for and received from Congress the ability to institute user fees for generic drugs. The result is a system that today brings generic drugs to market faster, saving consumers millions because, as Sklamberg notes, “the first and second generics have a dramatic impact on the price.” 

Accelerated drug reviews 

What Woodcock is perhaps most recognized for is her effort to modernize FDA’s drug review process, which accelerated review of promising drugs, especially those that would treat rare or severe illnesses such as cancer. 

“There are all sorts of cures for diseases now that simply did not exist when she became [CDER] director,” said Sklamberg. “A lot of diseases were death sentences back then. People take for granted that many of those conditions can now be treated.” 

Much of the law guiding the regulatory structure for drug reviews was written at a time when today’s precision medicine, biologic therapies and other cutting-edge treatments could not have even been imagined. The resulting process did not account for things like using real-world evidence for existing drugs needing new approvals or the inability to conduct timely and sound clinical trials for treatments for diseases that impact small numbers of people. 

Informed in part by her early-career experience with treatments for AIDS, Woodcock pushed for alternative methods of evaluating promising and highly needed drugs when more conventional approaches were not feasible or would be too slow. 

Critics argue that this system enabled risky drugs to enter the market and point to instances where FDA approvals granted under these accelerated reviews were later rescinded when the drugs proved to be ineffective. But Woodcock believes that people with debilitating or life-threatening illnesses should not be made to wait a decade or more for a treatment that could help them now. 

“My job was to serve the patients,” Woodcock said. “If there is a breakthrough therapy, patients deserve to get that as soon as possible.”