Janet Woodcock

Janet Woodcock (born August 29, 1948) is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). 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. 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.”

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research 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.

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

Woodcock informs Congress and other government bodies about the FDA and its concerns in order to guide policy recommendations and legislation. She has been praised for her directness.

Critical Path Initiative 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 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. 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 implementation of the Generic Drug User Fee Amendments of 2012, which built upon the Prescription Drug User Fee Act by requiring generic drug manufacturers to fund increased FDA investigations of offshore manufacturing plants. This equalized the regulatory burden of American generic drug manufacturers.a major reorganization of the generic drug program.

21st Century Cures Act Woodcock has also supported the 21st Century Cures Act.

Controversy

Opioid crisis On January 27, 2021, a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock's position as Acting Commissioner of the FDA. The letter said in part that "as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history." Examples of improper opioid decisions mentioned in the letter include "approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years old." 2018, Health Visionary Award, Society for Women's Health Research 2017, inaugural Leadership Award, Reagan-Udall Foundation, for "lifetime contributions and service to the field of regulatory science and public health." 2017, Florence Kelley Consumer Leadership Award, National Consumers League 2016, Innovators in Health Awards, NEHI (Network for Excellence in Health Innovation) 2016, Ellen V. Sigal Advocacy Leadership Award, Friends of Cancer Research 2015, Lifetime Achievement Award, Institute for Safe Medication Practices, given to “an individual who has had a significant career history of making ongoing contributions to patient safety and has had a major impact on safe medication practices.” 2021, included in a list of ten scientists who had had important roles in scientific developments in 2021 compiled by the scientific journal Nature.