Janet Woodcock

Janet Woodcock (born August 29, 1948) is an American physician serving as Principal Deputy Commissioner of Food and Drugs, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA).

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 (1978-1981) and the Veterans Administration Medical Center of the University of California, San Francisco (1982-1985), earning certifications in Internal medicine (1981) and Rheumatology (1984).

She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.

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.

Woodcock joined the U.S. Food and Drug Administration (FDA) in 1986, as the Director of the Division of Biological Investigational New Drugs in the Center for Biologics Evaluation and Research (CBER).

As of September, 1990, she became Acting Deputy Director of CBER.

She became Acting Director of the Office of Therapeutics Research and Review (part of CBER) as of November 1992, and was confirmed as Director of the Office of Therapeutics Research and Review as of November 1993.

As Director of the Office of Therapeutics Research and Review (1992–1994), Woodcock covered the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis.

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

As Director of CDER, beginning in 1994, Woodcock oversaw the modernization of CDER and FDA, streamlining review processes and standards, transitioning to electronic formats for submissions and decision-making processes, and making regulatory procedures, policies, and decisions publicly available.

She has supported the development of systems which encourage a high degree of participation by consumers, patients, and their advocates.

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

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.

From April 2004 to July 2005, Woodcock was Acting Deputy Commissioner for Operations at the FDA.

Beginning with the publication of Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products (2004)

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.

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.

From October 2007 to March 2008, Woodcock also served as Acting Director of the Center for Drug Evaluation and Research (CDER).

As of March, 2008, she became Director of CDER, a position which she held until April 12, 2021.

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.

- Representative John Dingell (D-Mich.), 2008

In 2012, the FDA rolled out the FDA Adverse Event Reporting System (FAERS), 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 (physicians, pharmacists, nurses and others) and consumers (patients, family members, lawyers and others).

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.

On April 12, 2021, Woodcock transitioned from her role as Director of CDER to Principal Medical Advisor to the Commissioner, while continuing to serve as Acting Commissioner.

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.”

- Janet Woodcock, 2018

Woodcock informs Congress and other government bodies about the FDA and its concerns in order to guide 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.

"“Again, I want it known that I appreciate Dr. Woodcock’s candor,” intoned Mr. Dingell, whose committee has jurisdiction over the FDA. “To her credit, she has stepped forth in the midst of a public health crisis to deal honestly with Congress. How I wish others in the administration showed the same vigor, responsiveness, and leadership.”"

She has also received the 2019 Biotechnology Heritage Award.