Janet Woodcock


Janet Woodcock is an American doctor of medicine and the current director of the Center for Drug Evaluation and Research, a department of the U.S. Food and Drug Administration. She joined the FDA in 1986, and has held a number of senior leadership positions there including terms as the Director of CDER from 1994-2004 and 2007–present. She has been described by the National Consumers League as "a passionate advocate for American patients and consumers, an ally to patient advocacy groups, and a fearless leader at the FDA."
Woodcock has overseen the modernization and streamlining of CDER and FDA, introducing new initiatives to improve the timeliness and transparency of FDA procedures, and the safety, quality and effectiveness of drugs. She informs the United States Congress and other government bodies about the FDA and its concerns, helping to develop policy recommendations and legislation.
In 2015, Woodcock received a Lifetime Achievement Award from the Institute for Safe Medication Practices, in recognition of “a significant career history of making ongoing contributions to patient safety.”
She has also received the 2019 Biotechnology Heritage Award.

Medical training

Woodcock received a Bachelor of Science in Chemistry from Bucknell University in 1970, and earned her Doctor of Medicine from the Feinberg School of Medicine at Northwestern University Medical School in 1977. She worked at the Hershey Medical Center at Pennsylvania State University and the Veterans Administration Medical Center of the University of California, San Francisco, earning certifications in Internal medicine and Rheumatology.

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research

Woodcock joined the U.S. Food and Drug Administration in 1986, as the Director of the Division of Biological Investigational New Drugs in the Center for Biologics Evaluation and Research. As of September, 1990, she became Acting Deputy Director of CBER. She became Acting Director of the Office of Therapeutics Research and Review as of November 1992, and was confirmed as Director of the Office of Therapeutics Research and Review as of November 1993.

Center for Drug Evaluation and Research

From May 1994 to April 2004 Woodcock served as Director of the Center for Drug Evaluation and Research of the FDA.

Office of the Commissioner

From April 2004 to July 2005, Woodcock was Acting Deputy Commissioner for Operations at the FDA.
From July 2005 to January 2007, she served as Deputy Commissioner for Operations and Chief Operating Officer of the FDA.
From January 2007 to March 2008, she served as Deputy Commissioner and Chief Medical Officer of the FDA.

Center for Drug Evaluation and Research

From October 2007 to March 2008, Woodcock also served as Acting Director of the Center for Drug Evaluation and Research. As of March, 2008, she became Director of CDER.
In addition to being the Director of CDER, she has concurrently served as Acting Director of the Office of Product Quality from October 2014 to September 2015; and as Acting Director of the Office of New Drugs from January 2017 to December 2018.

Contributions

As Director of the Office of Therapeutics Research and Review, Woodcock covered the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis.
As Director of CDER, beginning in 1994, Woodcock has been instrumental in the modernization of CDER and FDA, streamlining review processes, improving standards, transitioning to electronic formats for submissions and decision-making processes, and making regulatory procedures, policies, and decisions publicly available and transparent. She has supported the development of systems which encourage a high degree of participation by consumers, patients, and their advocates.
Woodcock informs Congress and other government bodies about the FDA and its concerns, helping to develop policy recommendations and legislation. She has testified before congress on at least 50 occasions, under six different U. S. presidents.
She has been praised for her directness.

Pharmaceutical Quality for the 21st Century

In 2000 Woodcock introduced the concept of risk management to the FDA's analysis of drug safety.
In 2002, she led the Pharmaceutical Quality for the 21st Century Initiative using a risk based approach to modernize pharmaceutical manufacturing and regulation.

Critical Path Initiative

Beginning with the publication of Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products
she has led the US Food and Drug Administration's Critical Path Initiative in an attempt to improve "development processes, the quality of evidence generated during development, and the outcomes of clinical use of these products."
Through public-private partnerships and the creation of consortia, the initiative seeks to apply advances in genomics, advanced imaging, and other technologies to the process of modern drug development. The goal is to more rapidly develop new medical discoveries in the laboratory and make them available to patients in need.

Safe Use and Safety First

Woodcock has also worked to improve the quality, effectiveness and safety of drugs through the Safe Use and Safety First initiatives, introduced in 2007–2008. Drug safety is viewed from a life-cycle perspective, examining each stage of the product life cycle.

FDA Adverse Event Reporting System (FAERS)

In 2012, the FDA rolled out the FDA Adverse Event Reporting System, replacing the earlier AERS system. FAERS is an online database that is used by the FDA for safety surveillance of all approved drugs and therapeutic biologic products. FAERS helps to track adverse event and medication error reports from health care professionals and consumers. It is used in combination with MedWatch and the Vaccine Adverse Event Reporting System is to identify potential safety concerns.

Sentinel Initiative

Another monitoring system, the Sentinel System, became fully operational in 2016. Woodcock launched the Sentinel Initiative in 2008 in response to passage of the Food and Drug Administration Amendments Act of 2007. The first Annual Sentinel Initiative Public Workshop was held in 2009, with subsequent yearly workshops to bring together possible stakeholders and explore a broad range of perspectives and issues. In 2009, the pilot program Mini‐Sentinel was launched. In 2014, expansion to a full system began.
The Sentinel System draws on existing databases of private health care insurers and providers to actively monitor for safety issues as they are developing, rather than relying on later third-hand reports. Woodcock has stated that the approach could “revolutionize” product safety.

Generic drug programs

In 2012 Woodcock oversaw a major reorganization of the generic drug program. The first generic drug user fee program, Generic Drug User Fee Amendments of 2012, was signed into law on July 9, 2012.
GDUFA was designed to build upon the 20-year-old Prescription Drug User Fee Act and improve the generic drug review and approval process.

21st Century Cures Act

Woodcock has also supported the 21st Century Cures Act.

Awards

Dr. Woodcock has received a great many awards, including the following: